Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique

Stopped early · Not applicable

Conditions studied: Barrett's Esophagus, High-grade Dysplasia in Barrett Esophagus, Low Grade Dysplasia in Barrett Esophagus

In brief

Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma). Currently, there is evidence that this change is initiated by acid reflux from the stomach which then could progress in a stepwise manner from the healthy epithelium to cellular changes (intestinal metaplasia, low-grade and high-grade dysplasia) and finally to adenocarcinoma. Surgery is considered the standard therapy for this cancer which involves the risk of death and complications with quality of life impairments. New possibilities for treatment have evolved with endoscopic therapies which allow for treatment of early changes of the epithelium (intestinal metaplasia and dysplasia) prior to the occurrence of cancer using either argon plasma coagulation (APC) or radiofrequency ablation (RFA). Both are established methods for eradication of BE by thermal ablation of the BE epithelium using high frequency current (HF). More advanced BE epithelium with early visible cancers are being treated by endoscopic mucosal resection (EMR). After EMR the residual Barrett's epithelium can also be removed by ablation with RFA or APC. Currently radiofrequency ablation (RFA) has been suggested as the standard therapy for BE treatment. Although effective in the eradication of the BE epithelium after RFA treatment the re-appearance of BE epithelium and the occurrence of complications such as strictures causing swallowing impairments for food have also been observed in clinical studies. A recently developed method is Hybrid argon plasma coagulation (ablation) \[HybridAPC® (HAPC)\] which combines argon plasma coagulation (APC) with a fluid injection function by a water beam. The water beam allows to establish a fluid cushion (normal sterile saline) right beneath the BE-epithelium prior to thermal ablation thereby protecting the esophagus wall from heat during ablation of epithelium with APC. The goal of this randomized controlled study is to investigate if HAPC is non-inferior to RFA in the stricture-free eradication of the dysplastic BE epithelium.

Key facts

Study ID

NCT03621319

Run by

Erbe Elektromedizin GmbH

People needed

41

Starts

2019-07-24

Expected to finish

2021-05-05

Last updated by the study team

2021-07-06

Who can join

Age: 18 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of 18-85 years (inclusive)
• Dysplastic BE, confirmed by the central pathologist; specifically:
• Low grade dysplasia documented on biopsy within 6 months of consent date or
• High grade dysplasia documented on biopsy within 6 months of consent date
• Barrett's extent of: C/M≥1 cm and C/M ≤ 6 cm using the Prague criteria [C = circumferential extent of disease / M = maximum extent of disease]
• Ability to provide written and informed consent

You may not qualify if…

• Barrett's extent of: C/M <1 cm or a C/M-value > 6 cm using the Prague criteria
• Prior EMR (endoscopic mucosal resection) for G3/G4; L1; V1; R1 (vertical margin only) or submucosal invasion;
• Presence of endoscopically visible abnormalities at the time of initial study treatment with HAPC or RFA. These participants can undergo EMR and then continue in the trial after a suitable healing period, provided randomization can occur within 90 days of consent.
• Presence of invasive cancer on biopsy
• Known pregnancy or plans to become pregnant
• Complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated;
• pre-existing significant esophageal pain or dysphagia;
• BE >80% has been resected by EMR;
• incomplete wound healing 3 months post-EMR despite adequate PPImedication;
• Prior ablative therapy in the esophagus but prior EMR allowed
• Active esophagitis or stricture precluding passage of scope
• Presence of esophageal varices
• Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to therapy or uncorrectable hemostatic disorders
• Life expectancy less than 2 years
• Previous gastrectomy or other gastric surgery other than uncomplicated fundoplication

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of California — Irvine, California, United States
• University of Colorado — Aurora, Colorado, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Kansas City Veterans Affairs Hospital — Kansas City, Missouri, United States
• Washington University, School of Medicine; Department of Internal Medicine; Division of Gastroenterology — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Columbia University Medical Center; Division of Digestive and Liver Diseases — New York, New York, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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