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Sponsors and Collaborators: |
BÂRRX Medical, Inc. AstraZeneca |
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Information provided by: | BÂRRX Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00282672 |
The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing Barrett's Esophagus.
Condition | Intervention |
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Barrett Esophagus |
Device: Ablation System plus anti-secretory medication Device: Sham procedure plus anti-secretory medication |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial) A Multi-Center, Randomized, Sham-Controlled Trial |
Enrollment: | 127 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SHAM: Sham Comparator
Approximately equal number of subjects with LGD and HGD (Planned 20 in each group).
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Device: Sham procedure plus anti-secretory medication
The Sham Control group undergo an upper endoscopy procedure with sizing of the esophageal diameter (a component of the ablation procedure steps, deemed the sham procedure) plus standard anti-secretory drug therapy (Proton pump inhibitor, PPI)
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TREATMENT: Active Comparator
Approximately equal number of subjects with LGD and HGD (Planned 40 in each group).
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Device: Ablation System plus anti-secretory medication
Treatment group subjects undergo up to 4 ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI).
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Barrett's esophagus or intestinal metaplasia (IM) is a change in the epithelial lining of the esophagus. Barrett's esophagus develops as a result of chronic exposure of the esophagus to refluxed stomach acid and enzymes, as well as bile, resulting in recurrent mucosal injury. Injury is accompanied by inflammation and, ultimately, a cellular change (metaplasia) to a specialized columnar epithelium (Spechler SJ. Barrett's Esophagus. N Engl J Med 2002;346(11):836-842.)
Patients who have a diagnosis of Barrett's esophagus typically undergo surveillance endoscopy every 1-3 years with multiple biopsy specimens obtained to facilitate early detection of progression of IM to dysplasia (more severe precancerous changes) and adenocarcinoma. (Sampliner RE. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus. Am J Gastro 2002;97:1888-1895.) Progression of IM to low-grade dysplasia (LGD) indicates that cells exhibit more "cancer-like" architecture, thus warranting an accelerated surveillance endoscopy and biopsy program every 6 months rather than every 1-3 years as indicated for non-dysplastic IM. Progression to high-grade dysplasia (HGD) indicates that the cells are even more "cancer-like", thus warranting an even higher frequency surveillance endoscopy and biopsy program (every 3 months). Many HGD patients may undergo photodynamic therapy (PDT) or surgical esophagectomy, rather than remain in a frequent surveillance program. This more aggressive therapy is warranted because of the high rate of progression of HGD to adenocarcinoma.
Esophageal adenocarcinoma most commonly occurs after an insidious progression from IM to LGD to HGD. Therefore, surveillance is increased upon diagnosis of worsening grades of dysplasia. The incidence of esophageal adenocarcinoma is rapidly increasing as middle-aged and elderly demographic sub-groups expand (Peters JH, Hagen JA, DeMeester SR. Barrett's Esophagus. J Gastrointest Surg 2004;8(1):1-17.) In 2004, the American Cancer Society reported that there were 14,250 new cases of esophageal cancer, and 13,300 deaths attributable to esophageal cancer (www.cancer.org). The U.S. National Cancer Institute Surveillance, Epidemiology and End Results Program reported that the increasing incidence of esophageal adenocarcinoma was greater than for any other cancer in the United States (www.cancer.gov).
Elimination of the diseased epithelium containing IM with dysplasia is an intuitively favorable step for patients with this diagnosis. In other disease states, such as colon polyps or premalignant skin lesions, removal of the premalignant tissue results in a reduction in the risk of ultimately developing cancer. This is a logical conclusion when considering the premalignant lesion of Barrett's esophagus (particularly Barrett's esophagus with dysplasia), as the "tissue at risk" can be completely removed by ablation. This premise has been tested in the Barrett's dysplasia population in photoablative trials using PDT for patients with HGD, where PDT imparted a 50% reduction in risk over controls for the development of adenocarcinoma (Overholt BF, Panjehpour M, Haydek JM. Photodynamic therapy for Barrett's esophagus: follow-up. Gastrointest Endosc 1999;49(1):1-7.) The AIM Dysplasia Trial primary endpoints are removal of all dysplasia and IM, rather than detection of a difference in progression to adenocarcinoma or higher grades of dysplasia.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects shall be screened according to the following inclusion criteria. An answer of "no" to any inclusion criterion disqualifies a subject from participating in this study.
Subject has documented diagnosis of IM, maximum endoscopic length of 8 cm (as measured endoscopically from the TGF to the most proximal extent of the IM (TIM); i.e. TGF-TIM [see Appendix B]), containing dysplasia as follows:
a. For LGD: i. LGD documented on biopsy within previous 12 months from enrollment while subject on PPI therapy ii. Histology slides reviewed at central pathology service for AIM Dysplasia Trial confirm LGD on first confirmatory central pathology review or, if necessary, confirm LGD on a tie-breaker review by a second pathologist b. For HGD: i. Regular, non-nodular, non-ulcerated mucosa ii. HGD documented on biopsy within previous 6 months from enrollment iii. Histology slides reviewed at central pathology service for AIM Dysplasia Trial confirm HGD on first confirmatory review or, if necessary, confirm HGD on a tie-breaker review by a second pathologist iv. Baseline Endoscopic ultrasound (EUS) within previous 12 months; 1. Catheter-based (probe) EUS excludes suspicious thickened Barrett's areas or, if suspicious areas found, prompts stacked biopsies of thickened area, the results of which do not render subject ineligible for enrollment
Exclusion Criteria:
Subjects shall be screened according to the following exclusion criteria. An answer of "yes" to any exclusion criterion disqualifies a subject from participating in this study.
History of Endoscopic Mucosal Resection (EMR) that meets any of the following criteria:
Study Director: | David S. Utley, MD | BÂRRX Medical, Inc. |
Responsible Party: | BÂRRX Medical, Inc. ( David S. Utley, MD ) |
Study ID Numbers: | B-204 |
Study First Received: | January 25, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00282672 |
Health Authority: | United States: Institutional Review Board |
Barrett's Esophagus Dysplasia Radiofrequency Ablation |
Digestive System Diseases Digestive System Abnormalities Esophageal disorder Gastrointestinal Diseases Metaplasia |
Barrett Esophagus Esophageal Diseases Congenital Abnormalities Barrett syndrome |
Pathologic Processes |