Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.

Inclusion Criteria:

• presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
• age 18 years or older
• participant has given informed consent

Exclusion Criteria:

• tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
• signs of systemic dissemination of tumor
• current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
• former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
• moribund patient
• limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
• pregnancy and lactation period