Endoscopic Full Thickness Resection for Gastric GIST

Not Applicable

Recruiting

• Conditions: Gastric GIST
• Interventions: Procedure: Endoscopic Full Thickness Resection

• Registration Number: NCT04198337
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST

Detailed Description

To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age > 18 and ≤ 80
2. Gastric submucosal tumors located at cardia, lesser curvature and antrum
3. Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic

Exclusion Criteria

1. Patients who are considered as unfit for general anesthesia
2. ASA class ≥ IV or moribund patients
3. Pregnancy
4. Gastric submucosal tumors located at greater curvature and fundus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Full Thickness Resection	Endoscopic Full Thickness Resection	Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop

Primary Outcome Measures

Name	Time	Method
Complete resection of GIST	30 days	Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins

Secondary Outcome Measures

Name	Time	Method
Hospital stay	30 days	Length of stay in hospital
Perioperative mortality	30 days	Death within 30 days after procedure
Adverse event rate	30 days	Adverse event as defined by presence of either postoperative bleeding or leakage after closure
Histolology assessment	30 days	Histology outcome as defined by any involvement of the tumor margins after resection
technical success in complete resection	1 day	Technical success defined by complete endoscopic resection, closure of the defect and delivery of the specimen per orally without need of conversion to laparoscopic surgery

Trial Locations

Locations (1)

Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, Outside Of US & Canada, China