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

This trial does not accept healthy volunteers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Endoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTR
Procedure/Surgery
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.
Submucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTR
Procedure/Surgery
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.

Treatment groups

136 Participants

are divided into 2 treatment groups

Group A: Endoscopic full thickness resection (EFTR) GroupExperimental treatment 1 intervention

Group B: Submucosal Tunneling Endoscopic Resection (STER) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Complete R0 resection

Complete R0 resection, defined as en-bloc complete endoscopic resection with intact tumor capsule and histological negative resection margins. Measure unit: % of lesions.

Time frame

1 day

Secondary outcomes

Rate of Intra-procedural adverse events

Intra-procedural adverse events (AE), including specific AE such as haemorrhage, tension capnoperitoneum, injury to adjacent peritoneal organs, unintentional mucosal injury / perforation, failed tumor retrieval, and general AE such as cardiovascular, pulmonary or other anaesthetic related events. All adverse events would be documented and graded based on the Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 and ASGE endoscopic adverse event Lexicon. Measure unit: % of procedure.

Time frame

1 day

Rate of post-procedural adverse events

Post-procedural adverse events within 30 days, including specific AE such as delayed haemorrhage, peritonitis, intra-abdominal abscess / collection, and general AE such as cardiovascular, pulmonary or other anaesthetic related events. All adverse events would be documented and graded based on the Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 and ASGE endoscopic adverse event Lexicon. Measure unit: % of procedure.

Time frame

30 days

Procedure time

Defined from beginning of mucosal incision until complete closure of the defect (full thickness defect or tunnel opening) after tumor resection. Measure unit: Minutes.

Time frame

1 day

Crossover rate to EFTR in STER group

Crossover rate to EFTR due to failure in STER group., defined as proportion of STER-assigned cases requiring crossover to EFTR (%). Measure unit: % of patients.

Time frame

30 days