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

April 30, 2025 updated by: Istituto Clinico Humanitas

Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ESD with clips
Closure of the defect will be performed at the end of the Endoscopic Submucosal Dissection procedure with clips (Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.
Experimental: 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.
Device: TTS suturing system
The use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the proportion of complete closure between the two groups
Time Frame: 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)
Intra-procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the closure procedure
Time Frame: 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)
up to 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of post-polypectomy syndrome
Time Frame: 1 week
To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7
1 week
Proportion of clinically significant delayed bleeding
Time Frame: 1 month
Compare and assess the proportion of clinically significant delayed bleeding at 1 month
1 month
Cost-effectiveness ratio
Time Frame: 1 month
To assess the cost-effectiveness ratio, estimated by dividing the difference in costs observed between the two strategies by the difference of effectiveness at 1 month. The effectiveness criterion being the closure time at 1 month
1 month
Length of hospitalization
Time Frame: up to 1 week
To compare the length of hospitalization defined as the number of procedural nights in the hospitals
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Alessandro Repici, Prof., IRCCS Humanitas Research Hospital - Rozzano 20089, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3938 - STITCH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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