RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility. Who May Qualify: - 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 - Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines) Who Should NOT Join This Trial: - 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. - Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above. - Pregnant women or those planning pregnancy or breastfeeding women. - Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl. - Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility. Inclusion Criteria: * 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 * Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines) Exclusion Criteria: * 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. * Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above. * Pregnant women or those planning pregnancy or breastfeeding women. * Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl. * Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants)

Treatments Being Tested

PROCEDURE

Endoscopic 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.

PROCEDURE

Submucosal 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.

Locations (4)

Department of Gastroenterology, Zhongshan Hospital of Fudan University

Shanghai, China

Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

Hong Kong, Hong Kong

Asian Institute of Gastroenterology

Hyderabad, India

Osaka International Cancer Institute

Osaka, Japan