MBM vs Cap for early esophageal squamous neoplasia.
Recruiting
- Conditions
- esophageal squamous cell neoplasia
- Registration Number
- NL-OMON25667
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
Pouw RE, van Vilsteren FGI, Peters FP, et al. Randomized trial on endoscopic resection-cap versus multiband mucosectomy for piecemeal endoscopic resection of early Barrett’s neoplasia. Gastrointest. Endosc. 2011;74(1):35-43.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Subject is 18-85 years of age, inclusive;
2. A lesion in the squamous esophagus that is visible with white light endoscopy and contains a type 0-IIa, 0-IIb and/or 0-IIc component;
Exclusion Criteria
1. Any type 0-I or 0-III lesion in the esophagus;
2. Any other neoplastic lesion in the squamous esophagus that is visible with white light endoscopy and can not be included in the TA to meet its maximum size requirements;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The percentage of subjects with complete endoscopic removal of the qualifying lesion including pre-randomisation markers at the first ER section;<br /><br>2. The percentage of subjects with no HGIN or ESCCA in biopsies obtained within 1-cm of the ER scar at 3 months follow-up.
- Secondary Outcome Measures
Name Time Method