Barrett s Esophagus. Radiofrequency Ablation with the HALO Technology A Reference Book

Size: px

Start display at page:

Download "Barrett s Esophagus. Radiofrequency Ablation with the HALO Technology A Reference Book"

Walter Parks
5 years ago
Views:

1 Radiofrequency Ablation with the HALO Technology A Reference Book

540 Oakmead Parkway, Sunnyvale, CA 94085 What is Barrett s esophagus?

2 540 Oakmead Parkway, Sunnyvale, CA What is Barrett s esophagus? Barrett s esophagus is a change that occurs within the cellular lining of the esophagus; the swallowing tube that carries foods and liquids from the mouth to the stomach. Barrett s esophagus is associated with an increased risk for developing esophageal cancer. Diaphragm Approximately 3.3 million adults in the United States have Barrett s esophagus.1,2 How does Barrett s esophagus develop? Esophagus Gastroesophageal reflux disease (GERD) is a disorder in which stomach acid and enzymes cause injury to the esophageal lining; producing symptoms such as heartburn, regurgitation, and chest pain. In some patients, the damage and inflammation associated with GERD can result in genetic changes which cause the cells to change from esophageal cells to intestinal cells. This change can be seen during an endoscopy procedure and is deemed Barrett s esophagus. Gastric Contents Barrett s Tissue 3 Gastroesophageal Junction It is estimated that 13% of the people who have chronic acid reflux also have.4 Stomach

540 Oakmead Parkway, Sunnyvale, CA 94085 How is Diagnosed?

3 540 Oakmead Parkway, Sunnyvale, CA How is Diagnosed? Normal Esophagus Barrett s Tissue Endoscopy (Esophagoscopy) A small flexible tube with a light at the end (the endoscope) is passed through the mouth and into the esophagus. This tube has a camera that allows the physician to look at the lining of the esophagus. 3 Endoscope Endoscopy is a non-surgical procedure and is typically performed using conscious sedation medications. Stomach Endoscopic Biopsy During the endoscopy, a sample of the tissue may also be obtained by the physician to confirm diagnosis as well as grade or further define the severity of the cellular changes. Tissue Normal Tissue Endoscopic visual of Barrett s within the esophagus. The Barrett s tissue is salmon-colored compared to the pink- colored normal tissue.

540 Oakmead Parkway, Sunnyvale, CA 94085 5-7 Biopsy samples from Barrett s esophagus tissue are examined

Low-grade Dysplasia Cellular abnormalities are more pronounced with the nuclei of the cells (dark blue)

Adenocarcinoma (esophageal cancer) Adenocarcinoma The abnormal cells have begun to change in size, shape,

4 540 Oakmead Parkway, Sunnyvale, CA Biopsy samples from Barrett s esophagus tissue are examined under a microscope by a pathologist to confirm the diagnosis and grade the severity of cellular changes (dysplasia). Intestinal Metaplasia (IM), or Non-dysplastic (NDBE) Intestinal Metaplasia Low-grade Dysplasia (LGD) Low-grade Dysplasia Cellular abnormalities are more pronounced with the nuclei of the cells (dark blue) being larger and more irregularly positioned. Adenocarcinoma (esophageal cancer) Adenocarcinoma The abnormal cells have begun to change in size, shape, or organization. High-grade Dysplasia (HGD) High-grade Dysplasia The earliest stage of Barrett s esophagus. Normal flat (squamous) cells are replaced with glandular intestinal cells. The most disorganized cell appearance with invasion of the cells into deeper tissue layers.

540 Oakmead Parkway, Sunnyvale, CA 94085 Radiofrequency Ablation of 8,9 In conjunction with an endoscopy, the HALO360+ or the HALO90 ablation catheter delivers radiofrequency energy to the targeted

5 540 Oakmead Parkway, Sunnyvale, CA Radiofrequency Ablation of 8,9 In conjunction with an endoscopy, the HALO360+ or the HALO90 ablation catheter delivers radiofrequency energy to the targeted tissue. Standardization of the electrode pattern, energy, power, and pressure against the tissue results in controlled ablation depth and uniform treatment. HALO360+ catheter is introduced over a guidewire Ablation Ablation is a general term that refers to the heating of unwanted or diseased cells to the point of cell death. Ablation has also been used for the control of bleeding (hemostasis). HALO Ablation Technology Ablation Effect The HALO technology delivers radiofrequency energy in a unique way, optimizing the removal of unwanted diseased tissue yet minimizing injury to normal esophagus tissue. Larger circumferential areas of Barrett s tissue are treated with the balloon-based + HALO360 ablation catheter, while smaller focal areas of Barrett s tissue are treated with the endoscope-mounted HALO90 catheter. Ablation Effect HALO90 catheter is mounted on the endoscope

540 Oakmead Parkway, Sunnyvale, CA 94085 Before the procedure Patients should follow the instructions provided by the physician or the nursing staff before the procedure.

6 540 Oakmead Parkway, Sunnyvale, CA Before the procedure Patients should follow the instructions provided by the physician or the nursing staff before the procedure. The following pre-procedure instructions were provided to patients in recently conducted clinical trials: No eating or drinking after midnight the day before the procedure. Arrange to have someone drive the patient home after the procedure. If a patient takes aspirin or blood thinning medication, he or she will receive instructions from their doctor when to stop taking them 7 days before each endoscopy (a patient must check with the prescribing physician before stopping any medication). The day of the procedure The treatment is typically performed in an outpatient setting and no incisions are involved. Ablation is performed in conjunction with an upper endoscopy procedure. While the actual procedure time in clinical studies has been less than 30 minutes, there is preparation required prior to the start of the procedure, and patients are monitored for a specific time afterwards. 8,9

540 Oakmead Parkway, Sunnyvale, CA 94085 8 After the Ablation Procedure Before the Procedure Symptoms Patients may experience some chest discomfort and difficulty swallowing for several days after

7 540 Oakmead Parkway, Sunnyvale, CA After the Ablation Procedure Before the Procedure Symptoms Patients may experience some chest discomfort and difficulty swallowing for several days after the procedure, both of which are managed with medications provided by the physician. In clinical trials, these symptoms typically resolved within 3-4 days. Patients are provided with anti-acid medications to promote healing of the esophagus. 8,9 DISCHARGE INSTRUCTIONS BASED ON CLINICAL TRIALS 10 It is very important that a patient follows the discharge instructions provided by the physician or the nursing staff after the procedure to ensure limited time of discomfort and ensure proper healing of the esophagus. Example of the image seen from the endoscope. The diseased tissue is shown in red. Follow-up Maximize anti-secretory regimen (for example, esomeprazole or Nexium 40 mg twice per day for 1-3 months, followed by at least 40 mg per day thereafter). Antacid/lidocaine mixture per oral prn. Liquid acetaminophen with or without codeine per oral prn. Anti-emetic medication per rectum prn. Sucralfate oral suspension, one gram up to 4 times per day. Full liquid diet for 24 hours, then advancing to soft diet for 1 week. Avoid aspirin or non-steroidal anti-inflammatory medications for 7 days (per physicians instructions). Patient instructed to contact treating physician immediately for significant chest pain, difficulty swallowing, fever, bleeding, abdominal pain, difficulty breathing, vomiting or other warning signs provided by the physician, so that the physician may complete the appropriate diagnostic work-up (contrast radiography, CT scan, or endoscopy) and/or provide the appropriate therapeutic intervention in order to avoid further complications. If the patient seeks care for a digestive issue from any healthcare personnel in the 6 months following the ablation procedure, other than the treating physician, the treating physician should be consulted before any treatment is initiated. THE INFORMATION PROVIDED IS INTENDED ONLY AS A GUIDE OR SAMPLE FOR PHYSICIANS AND NURSES WHO PROVIDE INSTRUCTION TO PATIENTS AFTER ESOPHAGOSCOPY AND ABLATION OF ESOPHAGEAL TISSUE. THIS INFORMATION IS NOT INTENDED TO INSTRUCT THE HEALTH CARE PROFESSIONAL IN THE PRACTICE OF MEDICINE AND SHOULD NOT REPLACE PROFESSIONAL JUDGMENT. ALTHOUGH WE SUPPLY THIS INFORMATION TO THE BEST OF OUR KNOWLEDGE, IT IS ALWAYS THE HEALTH CARE PROFESSIONAL S RESPONSIBILITY TO CREATE THEIR OWN VERSION OF THIS INFORMATION ACCORDING TO INDIVIDUAL PATIENT REQUIREMENTS, FACILITY POLICY, PHYSICIAN PREFERENCE, AND STANDARD OF CARE. Re-growth of healthy tissue occurs within two months within the treated area.

540 Oakmead Parkway, Sunnyvale, CA 94085 Treatment & 9 2 month Primary Radiofrequency Ablation (RFA) Procedure with the HALO360 or HALO90 System Follow-up A follow-up appointment is scheduled within

8 540 Oakmead Parkway, Sunnyvale, CA Treatment & 9 2 month Primary Radiofrequency Ablation (RFA) Procedure with the HALO360 or HALO90 System Follow-up A follow-up appointment is scheduled within 2 months to assess the response to the treatment. Endoscopy Visible Barrett s Tissue? NO YES Endoscopy with biopsy* If negative 4 month NO YES Endoscopy with biopsy* If negative In clinical studies, most patients required one circumferential ablation procedure and one or two focal ablation procedures. 8,9 Medical societies recommend surveillance for patients diagnosed with Barrett s esophagus. Patients undergo an upper endoscopy procedure with biopsies on a regular basis for the remainder of their lifetime. The frequency of endoscopy is determined by the grade of the Barrett s esophagus and the treatment regimen dictated by the physician. If positive RFA 6 month Surveillance Endoscopy Endoscopy Visible Barrett s Tissue? If there remains any residual Barrett s tissue, additional ablative therapy may be recommended (see sample from chart). If positive RFA Visible Barrett s Tissue? NO Endoscopy with biopsy* If negative YES GERD RFA Successful elimination of the Barrett s esophagus tissue does not cure pre-existing GERD or associated symptoms. Surveillance per baseline diagnosis & physician judgment * Endoscopic biopsy; a sample of the tissue is obtained by the physician to confirm diagnosis, grade of disease, or further define the severity of the cellular changes. The physician will guide the patient regarding long-term GERD therapy. This information is based on clinical trials. Patient management is at the discretion of the physician.

9 540 Oakmead Parkway, Sunnyvale, CA Clinical Trials Results Complete Response Complete Response Rate for RFA in Published Clinical Trials * 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 98.4% Intestinal Metaplasia >90% Low-grade Dysplasia >90% High-grade Dysplasia * Cure rates based on initial diagnosis and one or more clinical trials. In clinical studies, most patients required one circumferential ablation procedure and one or two focal ablation procedures. Complete response defined per trial (i.e. all biopsies obtained at last visit demonstrate absence of abnormal pathological finding). Clinical evaluations have been completed in the United States and Europe demonstrating the safety and efficacy of the HALO Technology for treating all types of Barrett s tissue. The Ablation of Intestinal Metaplasia (AIM) trial showed that 98.4% of patients with baseline non-dysplastic IM were completely free of all Barrett s tissue at 2.5 years of follow-up. 8 The AIM-LGD and AIM Dysplasia Trials applied RFA in a LGD patient population, and report complete eradication of all dysplasia in >90% of cases. 9,11 Results from several US and European trials have applied RFA in a HGD patient population, and report complete eradication of HGD in >90% of cases. 9,12,13,14 LGD = Low-grade Dysplasia HGD = High-grade Dysplasia AMC = Academic Medical Center

10 540 Oakmead Parkway, Sunnyvale, CA To learn more about Barrett s esophagus go to: /Patients_and_Families IMPORTANT REMINDER: This information is intended only to provide general information and not as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition, contraindications, and possible complications. This treatment is contraindicated in patients who are pregnant, have had prior radiation therapy to the esophagus, esophageal varices at risk for bleeding, eosinophilic esophagitis, or prior Heller myotomy. Possible complications may include: mucosal laceration, perforation of the esophagus requiring surgery, infection, bleeding, and stricture formation requiring dilation. The overall complication rate reported for this procedure is approximately < 0.2% Ronkainen J, Aro P, Storskrubb T, et al. Prevalence of Barrett s esophagus in the general population: an endoscopic study. Gastroenterology 2005; 129: Study provides first estimate of U.S. population affected by Barrett s esophagus. Gastro.org American Gastroenterological Association.< Accessed July 2007 Sharma VK and Fleischer DE. Barrett s esophagus and new therapeutic modalities. Therapy 2007; 4 (6): Westhoff B, Brotze S, Weston A, et al. The frequency of Barrett s esophagus in high-risk patients with chronic gerd. Gastrointestinal Endosc 2005; 61: Sharma P, Falk GW, Weston AP, et al. Dysplasia and cancer in a large multicenter cohort of patients with Barrett s esophagus. Clin Gastroenterol and Hepatol 2006; 4: What is dysplasia. barrettsinfo.com < Accessed July Dysplasia: What is it. John Hopkins website < Accessed July Fleischer DE, Overholt BF, Sharma VK, et al. Endoscopic ablation of Barrett s esophagus: a multicenter study with a 2.5 -year follow-up. Gastrointest Endosc - June 2008 ( /j.gie ) Nicholas J. Shaheen, A Randomized, Multicenter, Sham-Controlled Trial of Radiofrequency Ablation (RFA) for Subjects with (BE) Containing Dysplasia: Interim Results of the AIM Dysplasia Trial AGA Institute Clinical Science Plenary Session. 19 May Digestive Disease Week < accessed July Shaheen N, Ransohoff DF. Gastroesophageal reflux, Barrett s esophagus and esophageal cancer. Journal of the American Medical Association. 2002; 287: Instructions for Use Documents for the HALO360/HALO360+ (P/N XX) HALO90 (P/N XX) Ablation Catheters. 11. Sharma VK, Kim HJ, Das A, Dean P, DePetris G, Fleischer DE. A prospective pilot trial of ablation of Barrett s esophagus with low-grade dysplasia using stepwise circumferential and focal ablation (HALO system). Endoscopy May;40(5): Ganz RA, Overholt BF, Sharma VK, et al. Circumferential ablation of Barrett s esophagus that contains high-grade dysplasia: a U.S. Multicenter Registry. Gastrointest Endosc Jul;68(1): Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Krishnadath KK, Ten Kate F, Fockens P, Bergman JJ. Stepwise circumferential and focal ablation of Barrett s esophagus with high-grade dysplasia: results of the first prospective series of 11 patients. Endoscopy May;40(5): Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Ten Kate F, Fockens P, Bergman JJ. Effective treatment of early Barrett s neoplasia with stepwise circumferential and focal ablation using the HALO system. Endoscopy May;40(5): L Rev. A

Citation for published version (APA): Phoa, K. Y. N. (2014). Endoscopic management of Barrett s esophagus with dysplasia

UvA-DARE (Digital Academic Repository) Endoscopic management of Barrett s esophagus with dysplasia Phoa, Nadine Link to publication Citation for published version (APA): Phoa, K. Y. N. (2014). Endoscopic