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    Center of Excellence for Treatment of Barrett's Esophagus

    A Multidisciplinary Program By A Team of Excellence
    20 Years of Experience in Managing Over 1000 Barrett's Patients

    MISSION

    We strive to provide state-of-the-art treatments for management of Barrett's esophagus.

    We are dedicated to achieving the best treatment outcomes and patient satisfaction through a partnership between healthcare providers, research institutions, and support services.

    We will continue to provide training and education for physicians and healthcare providers to advance the treatments for Barrett's esophagus. 

    VISION

    We will be the leaders in the application of endoscopic treatments for Barrett's esophagus.


     

    Thompson Cancer Survival Center
    Knoxville, Tennessee

    Contact us with specific questions
    Phone: (865) 541-1433
    Fax: (865) 541-1585



    What is Gastroesophageal reflux disease (GERD)?
    Back to Top

    Gastroesophageal reflux disease (GERD) is the chronic backflow of stomach contents into the esophagus. While the tissue lining of the stomach is able to handle digestive contents such as acid, the lining of the esophagus is not. As a result, when stomach contents back up into the esophagus, it can cause a burning sensation commonly referred to as heartburn, the major symptom of GERD. In addition to heartburn, other symptoms associated with GERD include regurgitation, chest pain, hoarseness, wheezing, and chronic cough. A major complication of GERD is Barrett's esophagus, a premalignant condition of the esophagus.

    More than 15 million Americans suffer from daily heartburn. Until recently, treatment options for GERD have been limited to chronic drug therapy or anti-reflux surgery. While prescription medications help suppress acid production, they do not prevent the physical backflow of gastric contents into the esophagus. Anti-reflux surgery is effective in addressing the root cause of GERD by correcting the weakened valve mechanism; however, such surgery requires general anesthesia, multiple incisions and a recovery period lasting several days. An endoscopic procedure called full thickness plication is now available that can reduce or eliminate the need for prescription medication in most patients.


    What is Barrett's Esophagus? Back to Top

    Barrett's esophagus is a precancerous condition that develops in approximately 10% of patients who have gastroesophageal reflux disease (GERD). In Barrett's esophagus, the normal cells that line the esophagus, called squamous cells, turn into a type of cell called specialized columnar cells or Barrett's esophagus.

    Diagnosis of Barrett's esophagus involves an endoscopy procedure to look at the lining of the esophagus and biopsies to examine samples of suspect tissue. To do an endoscopy, your doctor gently guides a long, thin tube called an endoscope through the mouth and into the esophagus. The endoscope contains a camera and light that allows the doctor to see the lining of the esophagus and to remove a small tissue sample, called a biopsy. The biopsy will be examined in a lab to see whether the normal squamous cells have been replaced with Barrett's cells.

    Once the cells in the lining of the esophagus have turned into Barrett's cells, they will not revert back to normal. In about 5% of patients, Barrett's cells may develop abnormal changes called dysplasia. Over several years, the dysplasia may progress to adenocarcinoma (cancer) of esophagus. Patients with Barrett's esophagus are 30-40 times more likely to develop esophageal cancer than the normal population.

    There are different grades of dysplasia. Most patients will not develop any dysplasia within their Barrett's esophagus. Barrett's esophagus without dysplasia is also called intestinal metaplasia. In some patients, the Barrett's cells may progress to low grade dysplasia which is worse than intestinal metaplasia. Barrett's cells may become more dysplastic and develop into high grade dysplasia. High grade dysplasia is very similar to carcinoma in situ, or superficial cancer. Carcinoma in situ will eventually develop into invasive esophageal cancer if not treated.


    What are the treatment options for Barrett's esophagus? Back to Top

    Treatment options for Barrett's patients depend on the grade of dysplasia. The Center provides a variety of treatment options for patients with or without dysplasia. Until recently, the only treatment for patients with high grade dysplasia was esophagectomy, or surgical removal of the esophagus. The Center utilizes several outpatient endoscopic procedures for treatment of Barrett's esophagus to include Photodynamic Therapy (PDT), Radiofrequency ablation (BÂRRX procedure), Cryotherapy, Thermal laser ablation and Endoscopic Mucosal Resection (EMR). An option for patients who do not have any dysplasia (have intestinal metaplasia) is observation with regular endoscopy and biopsies. If dysplasia is detected, treatment option may be offered.

    Patients who have nodular disease (small lumps) within their Barrett's esophagus, may be candidates for a procedure called Endoscopic Mucosal Resection (EMR) followed by either PDT, BARRX, cryotherapy, laser ablation or additional EMR. An endoscopic ultrasound (EUS) of the nodular area is sometimes performed to determine whether endoscopic ablation procedures are appropriate for the patient.


    What is Photodynamic Therapy (PDT)? Back to Top

    • How Does Photodynamic Therapy Work?
    Photodynamic therapy (PDT) is a treatment that uses a combination of photosensitizer (a light-activated drug) and laser light to destroy abnormal cells. PDT patients are injected with a photosensitizer to render their tissue extremely sensitive to laser light. The lesion is then illuminated with a laser light of proper power and wavelength (color). The interaction of laser light and the photosensitizer causes a chemical reaction, killing the abnormal cells. Photodynamic therapy can be used to reduce the tumor mass in patients with advanced esophageal cancer. However, a primary use of PDT is as an alternative to esophagectomy (the surgical removal of the esophagus) for patients with high-grade dysplasia and early cancer in Barrett's esophagus.

    • Photodymanic Therapy For Barrett's Esophagus
     

    Three Generations of PDT Balloons
    Until recently, the standard treatment for patients with high-grade dysplasia was esophagectomy. This is an invasive surgical procedure associated with a 3.4%-19% mortality rate and significant morbidity. Typically, patients require several weeks of hospitalization and full recovery may take months.

    Photodynamic therapy is an alternative outpatient endoscopic procedure for patients with high-grade dysplasia in Barrett's esophagus. During PDT, patients are injected with a photosensitizer (Photofrin). Laser light is delivered two to three days later using a specially designed light delivery balloon. A side effect of Photofrin is light sensitivity. Patients must avoid direct exposure to sunlight and bright lights for about 4-6 weeks. The primary complication of PDT for Barrett's esophagus is esophageal stricture, scarring and narrowing of the esophageal lumen. This occurs in approximately 20% of patients and is managed by dilation. We are currently working on reducing or eliminating the stricture formation.

    The PDT balloon, which is necessary for effective delivery of laser light to Barrett's esophagus, was clinically developed and tested at the Laser Center, where all the treatments are performed. The Laser Center is considered a world leader in the use of balloon-PDT for Barrett's esophagus.













     


    What is BÂRRX procedure for Barrett's esophagus? Back to Top

       BÂRRX Halo360 System
      
    BÂRRX Halo90 System
    BÂRRX procedure ( Radiofrequency Ablation) is a new endoscopic technique used for treatment of patients with Barrett's esophagus with or without dysplasia. Barrett's esophagus without dysplasia is also called intestinal metaplasia.

    During the procedure, the exact diameter of the esophagus is measured using an automated dilation catheter. Then using a proper sized ablation catheter called HALO360, radiofrequency (RF) energy is delivered to a 3 cm circumferential segment of the Barrett's esophagus. Delivery of energy is automated and takes a few seconds. The energy is adjusted to allow a limited depth of injury to destroy the Barrett's cells without destroying the normal tissue in the deeper layer. The ablation may be repeated until the entire length of the Barrett's segment is treated.

    Short segments or small patches of Barrett's esophagus may be treated using a probe called HALO90. HALO90 probe is the size of a small postage stamp. The HALO90 probe is attached to the end of the endoscope before the endoscopy procedure. The endoscope/probe is passed into the esophagus where the Barrett's esophagus is visualized. The RF energy is then delivered to the Barrett's mucosa.

    Following the procedure, patients may experience mild pain and/or nausea for several days. These symptoms are easily controlled with medications. Patients must stop taking all blood thinners several days before and after the procedure (number of days depends on the type of blood thinner). Patients are advised to stay on clear liquids for 24 hours followed by a soft food diet for several days after the procedure.

    The procedure is performed on an outpatient basis under moderate sedation. Typically, the procedure takes about 15-20 minutes and is well tolerated by patients. There is a small risk of developing esophageal stricture after this procedure which may depend on the length of treated area.

    About three months after the treatment, patients need to have an endoscopy with biopsies performed to evaluate the effectiveness of the treatment. Several additional follow-up endoscopies are recommended. In a clinical study, 75% of patients treated were clear of their Barrett's esophagus at 6 months. In the remaining 25% of patients, greater than 90% of Barrett's tissue was removed. Effective proton pump inhibitor (PPI) therapy is critical to control the acid reflux during the healing process.

    BÂRRX Ablation System: RF generator and ablation catheter

    Schematic of HALO 360 Balloon Ablation Device
    HALO90 probe

     
      Barrett's esophagus immediately after BÂRRX ablationEndoscopic view after sloughing



    What is Endoscopic Mucosal Resection (EMR)? Back to Top

    Endoscopic Mucosal Resection (EMR) is a procedure that is available for removal of small nodules within the Barrett's segment. These nodules are typically a sign of disease progression and should be removed before they become invasive cancer. Using Duette® Multi-Band Mucosectomy device, the nodules are removed by endoscopically placing a tiny rubber band around the nodule, making it easier to grasp. Then, an electrosurgical snare is used to cut and remove the nodule. EMR may also be used for treatment of small areas non-nodular Barrett's esophagus with dyspalsia.

    EMR is performed during a routine endoscopy under moderate sedation. Several weeks after the site of EMR has healed, patients may receive PDT, BARRX, laser ablation, cryotherapy, or additional EMR, depending on the results of the pathology. An advantage of EMR technique is that not only the nodule is removed, a pathological examination of the nodule is also obtained, which helps in determining the depth of abnormal cells. This helps in staging the progression of disease in Barrett's patients.


    What is endoscopic thermal ablation? Back to Top

    Endoscopic thermal ablation is an outpatient procedure that uses a laser (or non laser) source to thermally burn Barrett's tissue. The Center provides an Nd:YAG laser with contact probe to accurately treat small areas of Barrett's esophagus that are not suitable for photodynamic therapy, BÂRRX or cryotherapy. Nd:YAG laser is also used during the follow-up endoscopy of patients who return with small islands of Barrett's mucosa. Bipolar or monopolar electrocoagulation techniques are also available and may be used at the discretion of physician.


    What is Cryotherapy? Back to Top

    Cryotherapy is an outpatient endoscopic procedure that uses extreme cold for targeted treatment of focal or large areas of esophagus under direct visualization.

    The Center provides cryotherapy for management of Barrett's esophagus using the CSA Medical liquid nitrogen CryoSpray System (-196°C). The system delivers low pressure liquid nitrogen to the area using a small open-tipped catheter passed through an endoscope.

    Rapid delivery of repetitive freeze-thaw cycles initiates delayed injury which may be apparent 24-48 hours after the treatment. This procedure has been shown in clinical studies to destroy pre-cancerous and cancerous cells with subsequent regrowth of normal esophageal lining.



    The procedure takes a few minutes, is well tolerated, and patients may return to normal activity the same day.






    What is Bravo pH Monitoring? Back to Top

    Accurate diagnosis of gastroesophageal reflux disease (GERD) is critical before an effective treatment is initiated.

    The Center uses the world's first catheter-free test for GERD diagnosis called the Bravo® pH Monitoring System.

    Using the Bravo system, a miniature pH capsule, approximately the size of a gel cap, is temporarily attached to the wall of your esophagus during a routine endoscopy.

    The capsule measures pH levels in the esophagus continuously for 48 hours and transmits the data wirelessly to a portable receiver worn on the patient's waistband. There's no cumbersome catheter or visible wires. After the capsule stops transmitting data, the patient returns the receiver to the Laser Center. The pH data is then retrieved from the receiver. Several days after completion of the study, the capsule spontaneously sloughs off the wall of the esophagus and is passed through the gastrointestinal tract.

    These pH measurements allow the physician to effectively evaluate the acid reflux symptoms and recommend treatment options. The Bravo pH monitoring system allows patients to continue normal activities during the test period, so the patient can eat and drink normally, bathe, sleep comfortably, and maintain daily life.

    Patients are restricted from undergoing an MRI (Magnetic Resonance Imaging) for thirty days after the Bravo procedure.





    About the Center of Excellence     Back to Top

    Background

    The Center of Excellence for treatment of Barrett's esophagus is an alliance of numerous professionals from several clinical institutions, research organizations, and supporting services, which together form the Components of the Center of Excellence. A complete list of the Components and their roles in the program is provided later in this section.

    The Center of Excellence combines the expertise of a variety of disciplines to provide comprehensive and well coordinated care for patients, as well as to conduct pre-clinical and clinical research. This partnership has resulted in the introduction of new treatments for patients and the development of new technologies for early detection of cancer.

    Photodynamic therapy for Barrett's esophagus with high grade dysplasia was pioneered in 1990 at the Laser Center, located on the 4th floor of the Thompson Cancer Survival Center. Since then, the treatment has been improved through application of several generations of light delivery balloons. The Laser Center was one of the first institutions introducing BÂRRX procedure for treatment of Barrett's esophagus and has treated more patients than any other center. Over two decades of experience has resulted in excellent treatment outcomes in our patients (see Publications By Our Staff).

    State-Of-The-Art Treatment and Technology 

    State-Of-The-Art Treatment and Technology The center is a state-of-the-art outpatient endoscopy facility equipped to provide an array of treatment options for patients with Barrett's esophagus to include Photodynamic Therapy, BARRX procedure, Cryotherapy, Nd;YAG contact laser treatment, Endoscopic Mucosal Resection (EMR) and bipolar or monopolar electrocoagulation. Diagnostic procedures such as Endoscopic Ultrasound (EUS) for staging of disease as well as Bravo pH monitoring for GERD patients are also used routinely.

    International Leadership

    The Laser Center is internationally known as a leader in the treatments for Barrett's esophagus. The Laser Center has gained this reputation as a result of innovations in protocol development, excellent treatment outcomes in a large number of patients, numerous publications, and multiple presentations. The light delivery balloon for PDT was initially tested in our laboratory at the University of Tennessee's College of Veterinary Medicine. The clinical development of the balloon followed at the Laser Center. This work led to a multicenter international study for treatment of HGD in Barrett's esophagus, which was conducted under the direction of the Medical Director of the Center of Excellence.

    Distribution of Patients Referred to Laser Center

    Click on image above for larger version

    Patients are referred to the Laser Center from all areas of the United States and from other countries. To date, patients have traveled to the Laser Center from 41 states and several foreign countries. In fact, 25% of patients enrolled under the multicenter international PDT study have been treated at the Laser Center. The Laser Center is routinely invited to participate in pre-clinical and clinical trials of new treatments. The clinical staff regularly chair and moderate national and international conferences and serve as reviewers for medical and scientific journals where related papers are published.

    Clinical and Pre-Clinical Research

    The Center of Excellence is committed to improving patient care and treatment outcomes through clinical and pre-clinical research.

    The clinical research program has been active since 1989 in collaboration with Clinical Trials Department, located on the 7th floor of the Thompson Cancer Survival Center. Clinical studies have been conducted using numerous photodynamic therapy protocols and ablation procedures. Through clinical research, the Laser Center has obtained extensive experience in applying PDT for a variety of conditions such as Barrett's esophagus (BE), esophageal cancer, lung cancer, skin cancer, metastatic breast cancer, Kaposi's sarcoma, and other cutaneous cancers.

    The Medical Director of the Center of Excellence has an Investigational New Drug (IND) filed with the Food and Drug Administration (FDA) for clinical studies using Photofrin. All of the research on BE, esophageal cancer, and skin cancer has been conducted under this IND. The development and testing of the light delivery balloon for PDT of Barrett's esophagus was also conducted under this IND.

    The pre-clinical research program is conducted at the College of Veterinary Medicine, University of Tennessee which has Laboratory space assigned for our collaborative work. The animal studies conducted there were instrumental in the development of the balloon light delivery device for PDT, a critical element in improving treatment outcomes. In addition, the partnership with scientists at the Oak Ridge National Laboratory has resulted in the development of techniques for early detection of cancer in Barrett's esophagus and skin cancers such as basal cell carcinoma and squamous cell carcinoma.

    Our faculty have received funding for clinical and pre-clinical research from:


    And several PDT pharmaceuticals such as:

    Educational Services and Outreach Program

    The Laser Center is a national training facility for treatment of Barrett's esophagus and esophageal cancer where trainees learn the proper application of different treatments. Our hands-on teaching laboratory is located in the College of Veterinary Medicine, where physicians and nurses practice in an animal model. Physicians and nurses from many prestigious medical centers around the country and Europe have been trained here.

    Educational Services and Outreach Program Patient education is strongly emphasized in our program via personal phone discussions between our patients, physicians and staff. An extensive array of brochures and other informative material is mailed to patients before they come for treatment. Prior to the procedure, the nurse contacts the patient and discusses the treatment in detail. Ample opportunity is provided for the patients to ask questions.

    The Laser Center publishes a semiannual newsletter for several thousand physicians and patients around the country. It provides articles about the most recent advances in the treatments for Barrett's esophagus as well as answers to frequently asked questions.

    Outcome Comparison Against External Benchmarks

    Continuous comparison of outcomes against external benchmarks is achieved via publications, presentations, and literature reviews. The faculty have published over 45??clinical and pre-clinical papers in medical and scientific journals along with several book chapters and review articles (see Publications By Our Staff).

    In addition, the faculty routinely present clinical and pre-clinical research papers at the annual meetings of the:
    This allows for face-to-face interaction with other physicians and scientists.

    Our Medical/Nursing Research Library, located on the 3rd floor of the Thompson Cancer Survival Center, conducts monthly searches of the published articles to keep abreast of the latest developments in the field of Barrett's esophagus.

    Excellent Patient Satisfaction

    Excellent Patient Satisfaction All patients are asked to complete a satisfaction survey. Asked to assign an overall satisfaction score of 1 to 10, with 10 being the most satisfied, 93% of the patients have registered a satisfaction score of 10. A pie chart of patient satisfaction scores is shown below (seventy-three patients, January 2001 through August 2002). High scores are the result of over a decade of clinical experience leading to a well-coordinated and well-established patient care process and excellent clinical outcomes.

    Full Range of Clinical Services

    We continuously strive to meet every need of our patients. Ancillary services such as laboratory, radiology and patient and family support are provided within the Thompson Cancer Survival Center. In the rare case of an emergency, inpatient services are available at Fort Sanders Regional Medical Center, across the street from the Thompson Cancer Survival Center.

    Components of The Center Of Excellence

    Back to Top

    Laser Center, Thompson Cancer Survival Center (TCSC)

    Laser Center, Thompson Cancer Survival Center (TCSC) The Laser Center occupies the fourth floor of the Thompson Cancer Survival Center where all clinical procedures are performed. The Laser Center is a state-of-the-art outpatient facility fully equipped to provide a full array of treatment options for Barrett's patients, such as Photodynamic Therapy, BÂRRX, Cryotherapy, EMR, thermal ablation as well as Bravo pH monitoring for patients with gastroesophageal reflux disease (GERD). All procedures are performed under moderate sedation or general anesthesia. The facility consists of the treatment area, recovery area, waiting room, registration area, patient education room, exam rooms, and administrative area. The Laser Center is staffed by laser treatment specialists, physicians, nurses, research staff, and administrative staff.

    Fort Sanders Regional Medical Center (FSRMC)

    Fort Sanders Regional Medical Center is a 556-bed hospital serving Knoxville and surrounding counties and is located across the street from the Thompson Cancer Survival Center. TCSC and the Medical Center provide laboratory, pathology, radiology, cardiology, and oncology services. FSRMC is used if a need for inpatient services arises.

    Gastrointestinal Associates (GIA) / The Endoscopy Center

    Gastrointestinal Associates (GIA)/The Endoscopy Center Gastrointestinal Associates (GIA) consists of thirteen gastroenterologists, a nurse practitioner, nurses and staff. The Endoscopy Center is a licensed ambulatory surgery center (ACS) associated with GIA where endoscopy procedures are performed. It holds the distinction of being the first certified freestanding endoscopic ASC in the nation. The group has been involved in photodynamic therapy for esophageal cancer and dysplasia in Barrett's esophagus since 1989. All screening and follow-up endoscopies for PDT patients are conducted at GIA/The Endoscopy Center, which is within five miles of the Laser Center.

    Clinical Trials Department, Thompson Cancer Survival Center (TCSC)

    Clinical Trials Department provides state-of-the-art clinical research for physicians and patients in the East Tennessee area. The staff includes a team of highly qualified oncology certified nurses who coordinate and perform data management for oncology protocols in cooperation with such NCI research groups as the Southwest Oncology Group, the National Surgical Adjuvant Breast and Bowel Program, and the Clinical Trials Support Unit. In addition, research is conducted in collaboration with several pharmaceutical sponsors and other cancer research centers. There are currently 45 active research protocols. There have been over 1500 patients enrolled in clinical trails since the department began in 1988. Clinical Trials department has been involved with Barrett's research since 1989. The department is located on the 7th floor of the Thompson Cancer Survival Center.

    College of Veterinary Medicine, University of Tennessee (UTCVM)

    The College of Veterinary Medicine at the University of Tennessee is the site of much of the pre-clinical PDT activities. The PDT Laboratory at the College is used for research and development of new techniques and devices as well as for hands-on training during our PDT courses. The Laboratory is equipped with PDT lasers and endoscopy systems similar to those used in our clinical areas. This laboratory was critical in testing and developing the balloon for PDT of Barrett's esophagus. The small animal clinic within UTCVM is the referral center for East Tennessee where client-owned animals have access to the latest in PDT treatments (experimental or approved procedures).

    Advanced Biomedical Science and Technology Group, Oak Ridge National Laboratory (ORNL)

    The Advanced Biomedical Science and Technology Group is a biomedical research division located at Oak Ridge National Laboratory, about 20 miles from the clinical facilities of the Center of Excellence. Scientists at ORNL conduct a variety of biomedical research projects. Currently, the group is involved in projects for non-invasive detection of PDT drugs to optimize treatment protocols. In addition, they have been involved in projects to optically detect dysplasia and early cancer in Barrett's esophagus.

    Covenant HomeCare

    Covenant HomeCare is the home health agency providing care for all PDT patients. The nurses are well trained to provide the individualized care required by these patients. The nurses work closely with the Laser Center staff to assure that the details of each patient's care are individually planned and implemented.

    Medical/Nursing Research Library

    The Medical/Nursing Research Library is located on the third floor of the Thompson Cancer Survival Center. It currently houses more than 5,000 books and subscribes to 175 clinical journals. The library is staffed with two librarians, who are available to provide immediate access to medical journals and up-to-the moment medical literature through library online databases. The library conducts monthly searches of databases for all relevant published papers.

    Fellowship Center

    The Fellowship Center is an outpatient-lodging center created to assist out-of-town patients and family members with housing while the patients receive care at the Thompson Cancer Survival Center or the Fort Sanders Regional Medical Center. The Fellowship Center consists of eighteen fully furnished apartments with laundry facilities. The apartments are provided free of charge to all patients. The services are totally sustained through the generosity of its guests and friends. The Fellowship Center is a member of the National Association of Hospital Hospitality Houses. The Fellowship Center is located within a block of the Laser Center.

    Thompson Cancer Survival Center Foundation

    The Thompson Cancer Survival Center Foundation, established in 1994, extends resources to such projects as therapeutic and diagnostic research, education, and direct patient care. The Foundation has been instrumental in the establishment of the photodynamic therapy program and continues its support through annual grant applications.

    American Laser Foundation

    American Laser Foundation was established in 1981 to enable research, training and education focusing on technologies and treatments utilizing lasers in the diagnosis and management of human diseases. American Laser Foundation provides support through grant applications.


    Lodging for Patients Back to Top

    For out-of-town patients and their family members, furnished apartments are provided at the Fellowship Center at no cost, eliminating hotel expenses. The Fellowship Center is located within a block of the Laser Center. The Fellowship Center provides transportation to and from the clinical areas.








    Team of Excellence Back to Top

    Team of Excellence Excellence may only be achieved by a multidisciplinary approach to patient care. Our Team of Excellence is a group of highly motivated and experienced physicians, scientists, nurses, technicians, and supporting staff with a common goal of delivering the best care to our patients. In addition, our patients constitute an important part of our team. In fact, our patients have been the best advocates of the program.

    The members of the Center of Excellence and their affiliations are:

    Clinical Staff: Affiliations

    Team of Excellence Bergein F. Overholt, M.D.: Laser Center, GIA, UTCVM
    Masoud Panjehpour, Ph.D.: Laser Center, UTCVM, ORNL
    John M. Haydek, M.D.: Laser Center, GIA
    Raj I Narayani, M.D.: Laser Center, GIA
    Shelly Abrams, BSN: Laser Center
    Mary N. Phan-Brooks, BS: Laser Center
    Vicki Forester, RN: Laser Center
    Mary Ann Whittaker: Laser Center
    Karen Abbott, LPN: GIA
    Kathy Karnes, RN: GIA
    Jennifer Raney, LPN: GIA
    Sue Thompson, RN, BSN, OCN, CCRC: Clinical Trials Department
    Missy Maynatt, BSN: Clinical Trials Department
    Joanne Bohl, RN, BSN, CRNI: Covenant HomeCare
    Kim Rebmann, RN, CRNI: Covenant HomeCare
    B.J. Shelton, RN, BSN, CRNI: Covenant HomeCare

    Preclinical Research Staff: Affiliations

    Masoud Panjehpour, Ph.D.: Laser Center, UTCVM, ORNL
    Bergein F. Overholt, M.D.: Laser Center, GIA, UTCVM
    Mary N. Phan-Brooks: Laser Center
    Robert C. DeNovo, DVM: UTCVM
    Alfred M. Legendre, DVM: UTCVM
    Tammy Moyers, LVMT: UTCVM
    Jimmy Hayes, LVMT: UTCVM
    Tuan Vo-Dinh, Ph.D.: ORNL
    Quan Liu, Ph.D., Postdoctoral Research Associate: ORNL

    Supporting Services Staff: Affiliation

    Sarah Whitley: Fellowship Center
    Wanda Witt: Fellowship Center
    Linda Edwards: Fellowship Center
    Gordon Ball: Fellowship Center
    Nedra Cook: Medical/Nursing Research Library
    Tabor Crombie: Medical/Nursing Research Library
    Sharon Mullens: TCSC Foundation
    Marilyn Bartling: American Laser Foundation


    Publications By Our Staff Back to Top

    Listed in reverse chronological order.

    Does Ablative Therapy for Barrett Esophagus Affect the Depth of Subsequent Esophageal Biopsy as Compared With  Controls?
    Bergein F. Overholt, MD, Patrick J. Dean, MD,
    Joseph A. Galanko, PhD, and Charles J. Lightdale, MD
    Journal of Clinical Gastroenterology,  May 18, 2010

    Requires: Get Adobe
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    The Case for Endoscopic Treatment of Non-dysplastic and Low-Grade Dysplastic Barrett’s Esophagus
    David E. Fleischer, Robert Odze, Bergein F. Overholt, John Carroll, Kenneth J. Chang, Ananya Das, John Goldblum, Daniel Miller, Charles J. Lightdale, Jeffrey Peters, Richard Rothstein, Virender K. Sharma, Daniel Smith, Victor Velanovich, Herbert Wolfsen, George Triadafilopoulos
    March 22, 2010, PubMed
    Requires: Get Adobe
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    Photodynamic therapy for Barrett's esophagus
    Panjehpour M and Overholt BF.
    In "Frontiers of Gastrointestinal Research Vol 27, Interventional and Therapeutic Gastrointestinal Endoscopy",  Klaus Monkemuller, C. Mel Wilcox and Miguel Munoz-Navas, editors. Page 128-139, 2010
    Requires: Get Adobe
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    Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia
    Nicholas J. Shaheen, M.D., M.P.H., Prateek Sharma, M.D., Bergein F. Overholt, M.D.
    The New England Journal of Medicine 2009
    Requires: Get Adobe Reader

    Photodynamic Therapy of Barrett’s Esophagus: Ablation of Barrett’s Mucosa and Reduction in p53 Protein Expression after Treatment.
    Panjehpour M, Coppola D, Overholt BF, Vo-Dinh T, Overholt S.
    Anticancer Research 2008; 28(1B): 485-489.

    Squamous Overgrowth Is Not a Safety Concern for Photodynamic Therapy for Barrett's Esophagus with High-Grade Dysplasia.
    Bronner MP, Overholt BF, Taylor SL, Haggitt RC, et al.
    In: Gastroenterology, Volume 136, Issue 1, Pages 56-64, January 2009

    Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up.
    Fleischer DE, Overholt BF, Sharma VK, Reymunde A, et al.
    In: Gastrointest Endosc. 2008 Nov;68(5):867-76

    Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia.
    Overholt BF, Wang KK, Burdick JS, Lightdale CJ, et al.
    In: Gastrointest Endosc. 2007 Sep;66(3):460-468.

    Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients.
    Sharma VK, Wang KK, Overholt BF, et al.
    In: Gastrointest Endosc. 2007 Feb;65(2):196-9.

    Porfimer Sodium Photodynamic Therapy for Management of Barrett's Esophagus with High Grade Dysplasia
    Masoud Panjehpour, Bergein F. Overholt.
    In: Laser in Surgery and Medicine, 2006, Volume 38, no 5, pages 390-395.

    Photodynamic Therapy for Barrett's High-Grade Dysplasia
    Overholt BF, Panjehpour M, Phan M.
    In: Handbook of Gastroenterologic Procedures / senior editor, Douglas A. Drossman; associate editors, Ian S. Grimm, Nicholas J. Shaheen, 4th edition.
    Lippincott Williams & Wilkins, 2005.

    An Educational Tool for Photodynamic Therapy of Barrett's Esophagus with High-Grade Dysplasia: From Screening through Follow-up
    Phan M, Dyke S, Whittaker MA, Simmerman A, Abrams S, Panjehpour M, Overholt BF.
    Gastroenterology Nursing
    2005 September/October; 28(5): 413-419

    Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial.
    Overholt BF, Lightdale CJ, Wang KK, Canto MI, Burdick S, Haggitt RC, Bronner MP, Taylor SL, Grace MG, Depot M; [On behalf of the International Photodynamic Group for High-Grade Dysplasia in Barrett's Esophagus].
    Gastrointestinal Endoscopy
    2005 Oct;62(4):488-498

    Optimization of light dosimetry for photodynamic therapy of Barrett's esophagus: efficacy vs. incidence of stricture after treatment.
    Panjehpour M, Overholt BF, Phan MN, Haydek JM.
    Gastrointestinal Endoscopy
    2005 Jan;61(1):13-8

    What is the best management strategy for high grade dysplasia in Barrett's oesophagus? A cost effectiveness analysis.
    Shaheen NJ, Inadomi JM, Overholt BF, Sharma P.
    Gut
    2004 Dec;53(12):1736-44

    Development of a fluorescence detection system using optical parametric oscillator (OPO) laser excitation for in vivo diagnosis.
    Song JM, Jagannathan R, Stokes DL, Kasili PM, Panjehpour M, Phan MN, Overholt BF, DeNovo RC, Pan X, Lee RJ, Vo-Dinh T.
    Technol Cancer Res Treat
    2003 Dec;2(6):515-23

    Photodynamic Therapy for Barrett's Esophagus with Dysplasia and/or Early Stage Carcinoma: Long Term Results
    Overholt BF, Panjehpour M, Halberg B
    Gastrointestinal Endoscopy
    2003; 58(2):183-8

    Therapeutic Applications of Lasers in Gastroenterology
    Panjehpour M, Overholt BF.
    Biomedical Photonics Handbook, Chapter 46, CRC Press, 2003

    Photodynamic Therapy Using Verteporfin (benzoporphyrin derivative monoacid ring A, BPD-MA) and 630 nm Laser Light in Canine Esophagus
    Panjehpour M, DeNovo RC, Petersen MG, Overholt BF, Bower R, Rubinchik V, Kelly B.
    Lasers in Surgery and Medicine
    2002;30(1):26-30

    Acid Suppression and Reepithelialization After Ablation of Barrett's Esophagus
    Overholt BF.
    Digestive Diseases
    2000-2001;18(4):232-9

    Evaluating Treatments of Barrett's Esophagus That Shows High-Grade Dysplasia
    Overholt BF.
    American Journal of Managed Care
    2000 Oct;6(16 Suppl):S903-8

    Laser-Induced Fluorescence Spectroscopy for in vivo Diagnosis of Nonmelanoma Skin Cancers
    Panjehpour M, Julius CE, Phan MN, Vo-Dinh T, Overholt S.
    Lasers in Surgery and Medicine
    2002;31(5):367-73

    Results of Photodynamic Therapy for Ablation of Dysplasia and Early Cancer in Barrett's Esophagus and Effect of Oral Steroids on Stricture Formation
    Panjehpour M, Overholt BF, Haydek JM, Lee SG.
    American Journal of Gastroenterology
    2000 Sep;95(9):2177-84

    Light Sources and Delivery Devices for Photodynamic Therapy in the Gastrointestinal Tract
    Panjehpour M, Overholt BF, Haydek JM.
    Gastrointestinal Endoscopy Clinics of North America
    2000 Jul;10(3):513-32

    Photodynamic Therapy in the Management of Barrett's Esophagus With Dysplasia
    Overholt BF, Panjehpour M.
    Journal of Gastrointestinal Surgery
    2000 Mar-Apr;4(2):129-30

    Results of Photodynamic Therapy in Barrett's Esophagus: A review
    Overholt BF.
    Canadian Journal of Gastroenterology
    1999 Jun;13(5):393-6

    Photodynamic Therapy for Barrett's Esophagus: Follow-up in 100 Patients
    Overholt BF, Panjehpour M, Haydek JM.
    Gastrointestinal Endoscopy
    1999 Jan;49(1):1-7

    Photodynamic Therapy in Barrett's Esophagus
    Overholt BF, Panjehpour M.
    Journal of Clinical Laser Medicine & Surgery
    1996 Oct;14(5):245-9

    Laser-induced Fluorescence for Esophageal Cancer and Dysplasia Diagnosis
    Vo-Dinh T, Panjehpour M, Overholt BF.
    Annals of the New York Academy of Sciences
    1998 Feb 9;838:116-22

    Photodynamic Therapy for Barrett's Esophagus: Cardiac Effects
    Overholt BF, Panjehpour M, Ayres M.
    Lasers in Surgery and Medicine
    1997;21(4):317-20

    Photodynamic Therapy for Barrett's Esophagus
    Overholt BF, Panjehpour M.
    Gastrointestinal Endoscopy Clinics of North America
    1997 Apr;7(2):207-20

    Photodynamic Therapy for Barrett's Esophagus: Clinical Update
    Overholt BF, Panjehpour M.
    American Journal of Gastroenterology
    1996 Sep;91(9):1719-23

    Endoscopic Fluorescence Detection of High-Grade Dysplasia in Barrett's Esophagus
    Panjehpour M, Overholt BF, Vo-Dinh T, Haggitt RC, Edwards DH, Buckley FP III.
    Gastroenterology
    1996 Jul;111(1):93-101

    Balloon Photodynamic Therapy of Esophageal Cancer: Effect of Increasing Balloon Size
    Overholt BF, Panjehpour M, DeNovo RC, Peterson MG, Jenkins C.
    Lasers in Surgery & Medicine
    1996;18(3):248-52

    Photodynamic Therapy With Porfimer Sodium Versus Thermal Ablation Therapy With Nd: YAG Laser for Palliation of Esophageal Cancer: a Multicenter Randomized Trial
    Lightdale CJ, Heier SK, Marcon NE, McCaughan JS Jr, Gerdes H, Overholt BF, Sivak MV Jr, Stiegmann GV, Nava HR.
    Gastrointestinal Endoscopy
    1995 Dec;42(6):507-12

    Photodynamic Therapy in Barrett's Esophagus: Reduction of Specialized Mucosa, Ablation of Dysplasia, and Treatment of Superficial Esophageal Cancer
    Overholt BF, Panjehpour M.
    Seminars in Surgical Oncology
    1995 Sep-Oct;11(5):372-6

    Barrett's Esophagus: Photodynamic Therapy for Ablation of Dysplasia, Reduction of Specialized Mucosa, and Treatment of Superficial Esophageal Cancer
    Overholt BF, Panjehpour M.
    Gastrointestinal Endoscopy
    1995 Jul;42(1):64-70

    Spectroscopic Diagnosis of Esophageal Cancer: New Classification Model, Improved Measurement System
    Panjehpour M, Overholt BF, Schmidhammer JL, Farris C, Buckley PF, Vo-Dinh T.
    Gastrointestinal Endoscopy
    1995 Jun;41(6):577-81

    In Vivo Cancer Diagnosis of the Esophagus Using Differential Normalized Fluorescence (DNF) Indices
    Vo-Dinh T, Panjehpour M, Overholt BF, Farris C, Buckley FP 3rd, Sneed R.
    Lasers in Surgery & Medicine
    1995;16(1):41-7

    Photodynamic Therapy for Esophageal Cancer Using a 180 Degrees Windowed Esophageal Balloon
    Overholt BF, Panjehpour M, DeNovo RC, Petersen MG.
    Lasers in Surgery & Medicine
    1994;14(1):27-33

    Tumor Cell-Enhanced Sensitivity of Vascular Endothelial Cells to Photodynamic Therapy
    Yang Z, Lu X, Frazier DL, Panjehpour M, Breider MA.
    Lasers in Surgery & Medicine
    1994;15(4):342-50

    A Centering Balloon for Photodynamic Therapy of Esophageal Cancer Tested in a Canine Model
    Overholt BF, DeNovo RC, Panjehpour M, Petersen MG.
    Gastrointestinal Endoscopy
    1993 Nov-Dec;39(6):782-7

    Comparative Study Between Pulsed and Continuous Wave Lasers for Photofrin Photodynamic Therapy
    Panjehpour M, Overholt BF, DeNovo RC, Petersen MG, Sneed RE.
    Lasers in Surgery & Medicine
    1993;13(3):296-304

    Photodynamic Therapy for Treatment of Early Adenocarcinoma in Barrett's Esophagus
    Overholt B, Panjehpour M, Tefftellar E, Rose M.
    Gastrointestinal Endoscopy
    1993 Jan-Feb;39(1):73-6

    Quantification of Phthalocyanine Concentration in Rat Tissue Using Laser-Induced Fluorescence Spectroscopy
    Panjehpour M, Sneed RE, Frazier DL, Barnhill MA, O'Brien SF, Harb W, Overholt BF.
    Lasers in Surgery & Medicine
    1993;13(1):23-30

    Cytokine Modulation of Endothelial Cell Sensitivity to Photodynamic Therapy
    Breider MA, Lu X, Panjehpour M, Frazier DL.
    Lasers in Surgery & Medicine
    1993;13(3):305-11

    Comparative Pharmacokinetics of the Photosensitizer Tin-Etiopurpurin in Dogs
    and Rats

    Frazier DL, Barnhill MA, Vo-Dinh T, Legendre AM, Overholt BF.
    Journal of Veterinary Pharmacology and Therapeutics
    1992 Sep;15(3):275-81

    Laser and Photodynamic Therapy of Esophageal Cancer
    Overholt BF.
    Seminars in Surgical Oncology
    1992 Jul-Aug;8(4):191-203

    Centering Balloon to Improve Esophageal Photodynamic Therapy
    Panjehpour M, Overholt BF, DeNovo RC, Sneed RE, Petersen MG.
    Lasers in Surgery & Medicine
    1992;12(6):631-8

    Nd:YAG Laser Hyperthermia Treatment of Rat Mammary Adenocarcinoma in Conjunction With Surface Cooling
    Panjehpour M, Wilke AV, Frazier DL, Overholt BF.
    Lasers in Surgery & Medicine
    1991;11(4):356-62

    Nd:YAG Laser-Induced Hyperthermia Treatment of Spontaneously Occurring Veterinary Head and Neck Tumors
    Panjehpour M, Overholt BF, Frazier DL, Klebanow ER.
    Lasers in Surgery & Medicine
    1991;11(4):351-5

    Nd:YAG Laser-Induced Interstitial Hyperthermia Using a Long Frosted Contact Probe
    Panjehpour M, Overholt BF, Milligan AJ, Swaggerty MW, Wilkinson JE, Klebanow ER.
    Lasers in Surgery & Medicine
    1990;10(1):16-24

    Blood Flow Values
    Milligan AJ, Panjehpour M.
    International Journal of Radiation Oncology, Biology, Physics
    1988 May;14(5):1056-7

    Laser Treatment of Esophageal Cancer
    Overholt BF.
    American Journal of Gastroenterology
    1985 Sep;80(9):719-20

    Canine Normal and Tumor Tissue Estimated Blood Flow During Fractionated Hyperthermia
    Milligan AJ, Panjehpour M.
    International Journal of Radiation Oncology, Biology, Physics
    1985 Sep;11(9):1679-84

    Laser Treatment of Upper Gastrointestinal Hemorrhage
    Overholt BF.
    American Journal of Gastroenterology
    1985 Sep;80(9):721-6

    The Relationship of Temperature Profiles to Frequency During Interstitial Hyperthermia
    Milligan AJ, Panjehpour M.
    Association for the Advancement of Medical Instrumentation
    1983 Jul-Aug;17(4):303-6


    Biographical Information Back to Top

    Biographical Information for Clinical and Pre-clinical Research Staff

    Bergein F. Overholt, M.D., FACP, MACG
    Bergein F. Overholt, M.D., FACP, MACGDr. Overholt is the Medical Director of the Center of Excellence. He is a gastroenterologist and the chief of the Laser Center and managing partner of Gastrointestinal Associates. His clinical and pre-clinical research in treatments for Barrett's esophagus have been the pioneering work in the field. He is considered an international leader in the use of PDT for Barrett's esophagus and has lectured and published extensively on the subject. He has served as President of the American Society for Gastrointestinal Endoscopy and the American Society of Outpatient Surgeons, and is a founding member and past President of the Tennessee Society for Gastrointestinal Endoscopy. He has served as Chief of Staff at St. Mary's Medical Center, Knoxville. He is a past Trustee of the American Society of Internal Medicine. He has received numerous professional and civic awards including the distinction of being named Master by the American College of Gastroenterology.
     


    John M. Haydek, M.D., FACP, FACG
    John M. Haydek, M.D., FACP, FACGDr. Haydek is a gastroenterologist at Gastrointestinal Associates. He joined the Laser Center in 1996 to work on photodynamic therapy for Barrett's esophagus. He has coauthored several papers as a result of his research on Barrett's. Dr. Haydek is a Fellow of the American College of Physicians and a Fellow of the American College of Gastroenterology. Prior to his relocation to Knoxville, Dr. Haydek worked as an academic gastroenterologist and assistant professor of medicine at Loyola University Medical Center and Hines V.A. Hospital in Chicago.







    Masoud Panjehpour, Ph.D.
    Masoud Panjehpour, Ph.D.Dr. Panjehpour is the Director of Research at the Laser Center. He is also a Research Associate Professor at the College of Veterinary Medicine and holds a visiting scientist appointment at Oak Ridge National Laboratory. His collaborative work with the College of Veterinary Medicine and Oak Ridge National Laboratory has resulted in several human clinical studies including development of balloon photodynamic therapy and non-invasive detection of cancer using laser induced fluorescence spectroscopy. He lectures extensively on PDT and has published numerous papers and book chapters. He is a member of the American Society for Laser Medicine and Surgery, American Society for Photobiology, the International Society for Optical Engineering (SPIE) and the American Gastroenterological Association.





    Raj I. Narayani, M.D., FACG
    Raj I. Narayani, M.D., FACGDr. Narayani is a gastroenterologist at Gastrointestinal Associates. He joined the Center to treat patients with Barrett's esophagus. He obtained his undergraduate and medical degrees at Vanderbilt University. He completed his Internal Medicine Residency and Gastroenterology Fellowship at the San Antonio Uniformed Services Health Education Consortioum in San Antonio, Texas. He then served as an academic Gastroenterologist at David Grant USAF Medical Center at Travis AFB, California for 4 years before joining GIA in 2005.

    His 10-year military career included an overseas deployment as a Critical Care Aeromedical Physician during Operation Enduring Freedom, and was further highlighted by earning a Meritorius Service Medal in 2005.

    Dr. Narayani is a Fellow of the American College of Gastroenterology and a member of the American Society for Gastrointestinal Endoscopy and American Gastroenterological Association.

    Tuan Vo-Dinh, Ph.D.
    Dr. Vo-Dinh is the Group Leader of the Advance Biomedical Science/Technology Group at Oak Ridge National Laboratory. He is an internationally recognized leader in the field of spectroscopy. He has published extensively and has received numerous awards for his research. His interests are in applications of lasers and light for detection of diseases and for non-invasive detection of PDT drugs in tissue for optimization of treatment parameters.

    Robert C. DeNovo, D.V.M., M.S., D.A.C.V.I.M.
    Dr. DeNovo is a Professor & Head of Department of the Small Animal Clinical Sciences at the College of Veterinary Medicine, University of Tennessee, and a Diplomate of the American College of Veterinary Medicine. He has been involved with the PDT program since 1989, when the preclinical research was initiated at the PDT Laboratory at the College of Veterinary Medicine. He has been instrumental in development of the animal studies and contributed to evaluation of light delivery devices currently in human use.

    Alfred M. Legendre, D.V.M., D.A.C.V.I.M.
    Dr. Legendre is a Professor of Medicine at the College of Veterinary Medicine at University of Tennessee. He is the chief of medical oncology at the small animal clinic. Dr. Legendre is a Diplomate of the American College of Veterinary Internal Medicine. He has been involved with veterinary application of lasers and PDT for treatment of client-owned animals at the small animal clinic.

    Shelly Abrams, RN; Vicki Forester, RN
    Ms. Abrams and Ms. Forester are the Laser Center nurses who coordinate the care of all patients. They start with patient education, obtain all consent forms, order lab work and check results, assist during all procedures, make follow-up calls and communicate all clinical issues with physicians. They are trained in care of conscious sedation patients and are certified in insertion of PICC lines.

    Kathy Karnes, RN
    Ms. Karnes is the Clinical Research Coordinator at Gastrointestinal Associates. She has been the study coordinator for several studies for treatment of Barrett's esophagus. She and her staff coordinate data collection and reporting for all studies conducted at the Center.

    Karen Abbott, LPN
    Ms. Abbott is Dr. Overholt's clinical nurse at GIA. She is responsible for the scheduling of PDT patients for esophageal procedures. She coordinates patient records and labs for review by the doctors and handles scheduling between patients, GIA, and the Laser Center.

    Jennifer Raney, LPN
    Ms. Raney is Dr. Haydek's clinical nurse at GIA. She is responsible for coordinating patient records and scheduling them for planning and follow-up endoscopies after treatments.

    Mary N. Phan-Brooks, BS
    Ms. Phan-Brooks is the Research Associate at the Laser Center. She is responsible for setup and operation of lasers and equipment used for treatments. She assists in treatment of esophageal, lung and skin cancers. She is responsible for collection and analysis of clinical data. She is also involved with the preclinical research conducted at ORNL and UTCVM.

    Sue Thompson, RN; Missy Maynatt, RN
    Ms. Thompson, and Ms. Maynatt are Research Coordinator Nurses at the Clinical Trials Department. They are responsible for coordination and management of data for treatment protocols conducted in collaboration with study sponsors.

    Mary Ann Whittaker
    Mary Ann WhittakerMs. Whittaker is the Project Coordinator for the Laser Center. She is often the first person who speaks to patients who inquire about treatment options. She answers questions about the treatment, mails out packets of information, collects and reviews patients' records, pre-certifies insurance and assists the patients and their families to make their treatment as pleasant as possible.

    Joanne Bohl, RN, BSN, CRNI,
    Kim Rebmann, RN, CRNI,
    B.J. Shelton, RN, BSN, CRNI
    Ms. Bohl, Ms. Rebmann, and Ms. Shelton are nurses at Covenant HomeCare, the home health agency used for our PDT patients. They are in charge of all aspects of home health for patients. They are specifically trained in the care and needs of these patients, including daily assessments and delivery of hydration and medications as needed.

    Tammy Moyers, LVMT, Jimmy Hayes, LVMT
    Ms. Moyers and Mr. Hayes are Licensed Veterinary Medical Technicians at the College of Veterinary Medicine, University of Tennessee. They assist in all preclinical research activities. They are also in charge of the PDT Laboratory used for the hands-on training of physicians and nurses.

    Quan Liu, Ph.D., Postdoctoral Research Associate
    Dr. Liu is a postdoctoral research associate at the Oak Ridge National Laboratory. He is involved with development of optical techniques for detection of dysplasia and early cancer in Barrett's esophagus.


    Contact Information Back to Top

    Center of Excellence for Treatment of Barrett's Esophagus Thompson Cancer Survival Center

    Mary Ann Whittaker
    Project Coordinator
    Laser Center
    Thompson Cancer Survival Center
    1915 White Avenue
    Knoxville, TN 37916

    Phone: (865) 541-1433
    Fax: (865) 541-1585
    Email: Mawhitak@covhlth.com

    Our website is: www.barretts-esophagus.org

    Additional information may be found at: www.gihealthcare.com