GIST治療におけるEFTRとSTERのRCT

基本情報

NCT ID: NCT07411118
ステータス: 募集中
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 136
治験依頼者名: Chinese University of Hong Kong

概要

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.

対象疾患

要旨小型消化管間質腫瘍

介入

Endoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTR(PROCEDURE)

Submucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTR(PROCEDURE)

依頼者（Sponsor）

Osaka International Cancer Institute(UNKNOWN)

Chinese University Of Hong Kong(OTHER)

Asian Institute Of Gastroenterology, India(OTHER)

Fudan University(OTHER)

実施施設 (1)

地方独立行政法人　大阪府立病院機構　大阪国際がんセンター

Osaka, Japan(NOT_YET_RECRUITING)