Endoscopic Full Thickness Resection for Gastric GIST

Gastric GIST Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198337
• Other study ID #: CREC 2014.293-T
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Philip Wai Yan Y Chiu, MD, FRCSEd
• Phone: +85235053952
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric GIST

Intervention

Procedure:
• Endoscopic Full Thickness Resection
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure

Locations

Country	Name	City	State
China	Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong	Outside Of US & Canada

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event rate	Adverse event as defined by presence of either postoperative bleeding or leakage after closure	30 days
Secondary	Perioperative mortality	Death within 30 days after procedure	30 days
Secondary	Histolology assessment	Histology outcome as defined by any involvement of the tumor margins after resection	30 days
Secondary	Hospital stay	Length of stay in hospital	30 days
Secondary	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