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)
1 other identifier
interventional
30
1 country
1
Brief Summary
This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 7, 2023
November 1, 2023
10.4 years
December 12, 2019
November 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Adverse event rate
30 days
Perioperative mortality
30 days
Histolology assessment
30 days
Hospital stay
30 days
technical success in complete resection
1 day
Study Arms (1)
Endoscopic Full Thickness Resection
EXPERIMENTALResection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop
Interventions
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure
Eligibility Criteria
You may qualify if:
- Age \> 18 and ≤ 80
- Gastric submucosal tumors located at cardia, lesser curvature and antrum
- Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic
You may not qualify if:
- Patients who are considered as unfit for general anesthesia
- ASA class ≥ IV or moribund patients
- Pregnancy
- Gastric submucosal tumors located at greater curvature and fundus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, Outside of US & Canada, 00000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Wai Yan Chiu, MD, FRCSEd
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 13, 2019
Study Start
August 1, 2014
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
November 7, 2023
Record last verified: 2023-11