RCT of EFTR Versus STER for GIST Treatment

ConditionsSmall Size Gastrointestinal Stromal Tumors GIST

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorChinese University of Hong Kong

About this trial

Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event.

This is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited.

Patients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.

Eligibility criteria

Qualifiers

Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and

Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter >=1.0cm and <= 3.5cm, and

Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and

Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or

Disqualifiers

Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any other reasons.

Patients with multiple tumors.

Patients unable or unwilling to provide consent.

Previous esophageal or gastric surgery.