History of Changes for Study: NCT04198337

Endoscopic Full Thickness Resection for Gastric GIST (EFTR)

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Study Record Versions

Version	Submitted Date	Changes
1	December 12, 2019	None (earliest Version on record)
2	February 1, 2021	Study Status and Sponsor/Collaborators
3	February 21, 2022	Study Status
4	November 4, 2023	Study Status

Comparison Format:

Study NCT04198337
Submitted Date: December 12, 2019 (v1)

Study Identification


Unique Protocol ID:	CREC 2014.293-T
Brief Title:	Endoscopic Full Thickness Resection for Gastric GIST (EFTR)
Official Title:	Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
Secondary IDs:

Study Status


Record Verification:	December 2019
Overall Status:	Recruiting
Study Start:	August 1, 2014
Primary Completion:	December 31, 2020 [Anticipated]
Study Completion:	December 31, 2021 [Anticipated]

First Submitted:	December 12, 2019
First Submitted that Met QC Criteria:	December 12, 2019
First Posted:	December 13, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	December 12, 2019
Last Update Posted:	December 13, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Chinese University of Hong Kong
Responsible Party:	Principal Investigator Investigator: Philip Wai Yan Chiu Official Title: Professor Affiliation: Chinese University of Hong Kong
Collaborators:

Study Description


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 Design

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Complete resection of GIST [ Time Frame: 30 days ] Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins
Secondary Outcome Measures:
1.	Adverse event rate [ Time Frame: 30 days ] Adverse event as defined by presence of either postoperative bleeding or leakage after closure
2.	Perioperative mortality [ Time Frame: 30 days ] Death within 30 days after procedure
3.	Histolology assessment [ Time Frame: 30 days ] Histology outcome as defined by any involvement of the tumor margins after resection
4.	Hospital stay [ Time Frame: 30 days ] Length of stay in hospital
5.	technical success in complete resection [ Time Frame: 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

Eligibility


Minimum Age:	18 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: 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 Exclusion Criteria: 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

Contacts/Locations


Central Contact Person:	Philip Wai Yan Y Chiu, MD, FRCSEd Telephone: +85235053952 Email: philipchiu@surgery.cuhk.edu.hk
Central Contact Backup:	Man Yee Yung Telephone: +35052956 Email: myyung@surgery.cuhk.edu.hk
Study Officials:	Philip Wai Yan Chiu, MD, FRCSEd Principal Investigator Chinese University of Hong Kong
Locations:	China, Outside Of US & Canada
	Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong [Recruiting] Hong Kong, Outside Of US & Canada, China, 00000 Contact:Contact: Philip WY Chiu, MD 85235053952 philipchiu@surgery.cuhk.edu.hk Contact:Contact: Man Yee Yung 85235052956 myyung@surgery.cuhk.edu.hk