What is Gastroesophageal reflux disease (GERD)?

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Gastroesophageal reflux disease (GERD) is the chronic backflow of stomach contents into the esophagus. While the tissue lining 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?

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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?

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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 out-patient 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)?

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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

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-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?

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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.

What is Endoscopic Mucosal Resection (EMR)?

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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?

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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?

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CSA Medical CryoSpray unit Endoscopic view during freezing

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?

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pH Capsule Delivery System Receiver

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

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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.

Components of The Center Of Excellence

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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.

Lodging for Patients

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Team of Excellence

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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

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

Publications By Our Staff

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Listed in reverse chronological order.

Biographical Information

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Biographical Information for Clinical and Pre-clinical Research Staff

Bergein F. Overholt, M.D., FACP, MACG
Dr. 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
Dr. 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.
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
Dr. 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
Ms. 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

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