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NCT Number: NCT06443047

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTS suturing system

Device

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

  2. Proportion of clinically significant delayed bleeding

    Time frame: 1 month

    Compare and assess the proportion of clinically significant delayed bleeding at 1 month

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro D'Aprano, Dr.

CONTACT

[email protected]

028224 3678

Alessandro Repici, Prof.

CONTACT

[email protected]

028224 7493

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: STITCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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