Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study|
- R0 Resection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Rate of R0 resections by an endoscopic approach for resection.
- Safety [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]Rate of complications
|Study Start Date:||April 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Study arm
Procedure: Endoscopic resection
Endoscopic resection of the gastric subepithelial mass
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105728
|Klinikum rechts der Isar|
|Munich, Bavaria, Germany, 81675|
|Principal Investigator:||Alexander Meining, MD||Klinikum rechts der Isar|
|Principal Investigator:||Stefan von Delius, MD||Klinikum rechts der Isar|
|Principal Investigator:||Hubertus Feußner, MD||Klinikum rechts der Isar|
|Principal Investigator:||Dirk Wilhelm, MD||Klinikum rechts der Isar|