Gastric Subepitelial Mass
Conditions
Keywords
Gastric subepitelial mass, Endoscopic full thickness resection
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.
Interventions
PROCEDUREEndoscopic resection
Endoscopic resection of the gastric subepithelial mass
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection | 30 minutes | Rate of R0 resections by an endoscopic approach for resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 30 minutes | Rate of complications |
Countries
Germany
Outcome results
None listed