Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects

Not Applicable

Not yet recruiting

• Conditions: Precancerous Lesion of Colon
• Interventions: Device: TTS suturing system

• Registration Number: NCT06443047
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.

Detailed Description

Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.

Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs.

Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time.

Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure

Study Timeline

• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Study Start: 2025-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patient suffering from 30-60 mm colonic polyps with indication of ESD
• Male or female patients aged > 18 years' old
• Patients able to fill in questionnaires written in Italian

Exclusion Criteria

• Failure of endoscopic resection
• Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
• Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
• Polyp inside the ileo-cecal valvula.
• Rectal lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TTS suturing system	TTS suturing system	Closure of the defect will be performed at the end of the ESD procedure with a new TTS suturing system (X-Tack Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.

Primary Outcome Measures

Name	Time	Method
Compare the proportion of complete closure between the two groups	Intra-procedural	To assess the proportion of complete closure, defined when opposite margins are drawn together without a persistent post-resection defect of more than 1 cm (pictures and/or videos)

Secondary Outcome Measures

Name	Time	Method
duration of the closure procedure	up to 2 hours	To assess the closure procedure time, which is defined by duration between the beginning of assemblage of the suturing system and the end of the closure in the intervention group and between the opening of the bag of the first clip until the end of the closure in the control group.(pictures-videos)