Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Technical University of Munich

Status and phase: Completed; Phase 1

Conditions: Gastric Subepitelial Mass

Treatments: Procedure: Endoscopic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01105728

2632/09

Details and patient eligibility

About

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).

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Study arm

Experimental group

Description:

Endoscopic resection

Treatment:

Procedure: Endoscopic resection