RecruitingNot ApplicableNCT07411118

RCT of EFTR Versus STER for GIST Treatment

Exposed Endoscopic Full Thickness Resection (EFTR) Versus Submucosal Tunnelling Endoscopic Resection (STER) for Small Gastric Gastrointestinal Stromal Tumor (GIST) - an International Double Blinded Randomized Controlled Trial

Sponsor

Chinese University of Hong Kong

Enrollment

136 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

GIST Small Size Gastrointestinal Stromal Tumors

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two minimally invasive endoscopic techniques — EFTR (full-thickness resection) and STER (submucosal tunneling resection) — for removing small stomach tumors called GISTs (gastrointestinal stromal tumors) without open surgery. **You may be eligible if...** - You are 18 to 75 years old - You have a suspected GIST (stomach subepithelial tumor) arising from the muscle layer, between 1 cm and 3.5 cm in diameter - Your tumor does not have high-risk features such as irregular margins or invasion into surrounding organs - An expert endoscopist has confirmed both procedures are technically feasible for your tumor's location **You may NOT be eligible if...** - Your tumor is not suitable for either endoscopic technique - You have multiple stomach tumors - You have had previous esophageal or gastric surgery - You have serious heart or breathing conditions that prevent general anesthesia (ASA grade III or above) - You are pregnant or trying to become pregnant - You have bleeding or clotting problems, or are on blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTR

The procedure would be performed in similar way as reported in the literature. A therapeutic endoscope would be used and the target lesion identified. After submucosal injection of solution around the lesion, mucosal incision would be performed with dedicated dissection knife, followed by submucosal dissection. After adequate submucosal dissection to expose the muscularis propria layer around the tumor, the muscle layer would be dissected to achieve full thickness resection. Care would be taken to avoid breaching of the tumor capsule during the procedure and to aim for en-bloc tumor resection. During the procedure, countertraction technique could be utilized according to the discretion of the endoscopists. Clip or snare related traction methods such as clip-line traction are allowed depending on the endoscopists' preference. In case of development of significant pneumoperitoneum, decompression could be performed by transcutaneous needle.

PROCEDURESubmucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTR

As with exposed EFTR, the STER procedure would also be performed in similar way as reported in literature. After identification of the tumor location, a mucosal incision would be made at 3-4cm proximal to it after submucosal injection of saline mixture. Submucosal tunnel would then be created until identification of the tumor within the tunnel. Circumferential dissection would then be performed around the tumor until complete resection is achieved. During the procedure, the dissection plane would aim to avoid breaching tumor capsule in similar manner with EFTR group. The resected specimen would then be retrieved through the tunnel opening. After confirming adequate haemostasis within the submucosal tunnel, the mucosal incision would be closed with TTS clips. In case of failure of STER, cross-over to EFTR would be allowed in order to achieve tumor resection.