Endoscopic Full Thickness Resection for Gastric GIST (EFTR)

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Gastric GIST

Treatments: Procedure: Endoscopic Full Thickness Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04198337

CREC 2014.293-T

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endoscopic Full Thickness Resection

Experimental group

Description:

Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop

Treatment:

Procedure: Endoscopic Full Thickness Resection