Prospective evaluation of efficacy and safety of argon plasma coagulation therapy with submucosal injection prior to ablation in Barrett's esophagus

Not Applicable

• Conditions: C15.5; Lower third of oesophagus

• Registration Number: DRKS00003369
• Lead Sponsor: HSK Wiesbaden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Study Completion: 2014-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

residual non-neoplastic Barrett's mucosa in the distal esophagus of at least 1 cm extent longitudinally or radially. Informed consent.

Exclusion Criteria

poor healing after previous endoscopic therapy, such as endoscopic resection; relevant comorbidity; other exclusion criteria such as pregnancy, age below 18 years, coagulation disturbances, renal insufficiency

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete ablation of Barrett's mucosa by means of injection APC after Endoscopic Resection of early Barrett's cancer. The efficacy of APC is measured macroscopically and histologically; the latter by means of four-quadrant biopsies out of the previous Barrett's segment. Patients will be recruited until the end of July 2012. Eight weeks after complete Barrett's ablation, check-up upper gastrointestinal endoscopy is carried out.

Secondary Outcome Measures

Name	Time	Method
Safety of injection APC:<br>The side effects of APC are documented in a specially designed prospective data sheet.