RCT of EFTR Versus STER for GIST Treatment

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.

Conditions

• Small Size Gastrointestinal Stromal Tumors
• GIST

Interventions

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.

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• Osaka International Cancer Institute

  collaborator UNKNOWN

• Asian Institute of Gastroenterology, India

  collaborator OTHER

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Hon Chi Yip · Chinese University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2032-12-01

Completion

2033-02-01

Countries

• China
• Hong Kong
• India
• Japan

Study Locations