Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Phase 1

Completed

• Conditions: Gastric Subepitelial Mass

• Registration Number: NCT01105728
• Lead Sponsor: Technical University of Munich

Brief Summary

Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip \[OTSC\] clips).

Detailed Description

During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Endosonographically suspicous gastric subepithelial mass <=3 cm.

Exclusion Criteria

• American Society of Anesthesiologists (ASA) classes IV or V
• Pregnancy
• Bleeding disorders
• Contraindications for endoscopy
• Endosonographically shown large vessels in the area for resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
R0 Resection	30 minutes	Rate of R0 resections by an endoscopic approach for resection.

Secondary Outcome Measures

Name	Time	Method
Safety	30 minutes	Rate of complications

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany