Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Terminated

• Conditions: Gastric Neoplasms; Gastrointestinal Stromal Tumors
• Interventions: Device: GERDX(TM)

• Registration Number: NCT02488746
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EFTR-GERDX	GERDX(TM)	Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

Primary Outcome Measures

Name	Time	Method
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved	intraoperative

Secondary Outcome Measures

Name	Time	Method
Number of participants with needs of surgical therapy or endoscopic re-resection	6 months after resection
Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved	within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of complications (bleeding, perforation)	6 months after resection
Duration of hospitalization	within one week after resection
Number of participants with local or systemic recidive of tumor	6 months after resection

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Baden-Württemberg, Germany