Endoscopic Full Thickness Resection for Gastric GIST (EFTR)

Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)

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

Study Overview

• Status: Recruiting
• Conditions: Gastric GIST
• Intervention / Treatment: Procedure: Endoscopic Full Thickness Resection

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Wai Yan Y Chiu, MD, FRCSEd; Phone Number: +85235053952; Email: philipchiu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Man Yee Yung; Phone Number: +35052956; Email: myyung@surgery.cuhk.edu.hk

Study Locations

• China
  • Outside Of US & Canada
    • Hong Kong, Outside Of US & Canada, China, 00000
      • Recruiting
      • Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
      • Contact: Philip WY Chiu, MD; Phone Number: 85235053952; Email: philipchiu@surgery.cuhk.edu.hk
      • Contact: Man Yee Yung; Phone Number: 85235052956; Email: myyung@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Full Thickness Resection; Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop	Procedure: Endoscopic Full Thickness Resection; Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete resection of GIST	Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Adverse event as defined by presence of either postoperative bleeding or leakage after closure	30 days
Perioperative mortality	Death within 30 days after procedure	30 days
Histolology assessment	Histology outcome as defined by any involvement of the tumor margins after resection	30 days
Hospital stay	Length of stay in hospital	30 days
technical success in complete resection	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	1 day

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Philip Wai Yan Chiu, MD, FRCSEd, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CREC 2014.293-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No