Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.

NCT06779266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 179

Last updated 2025-01-16

No results posted yet for this study

Summary

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding.

Conditions

  • Endoscopic Surgical Procedures

Interventions

PROCEDURE

Suturing

Endoscopic Suturing is a technique of the wound closure after advanced endoscopic third-space resections in the upper and lower gastrointestinal tract. In this technique, the needle is held on the opposite side from the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated from the middle of the wound to create a symmetrical structure.

PROCEDURE

Clipping

Clipping is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the through-the-scope clips are delivered to the site through the working canal. The arms of the clip are properly put on the both sides of the defect and the clip is closed to seal the margins. The procedure may be repeated along the resection site for complete closure.

PROCEDURE

No closure

The resection site after endoscopic submucosal dissection was left open, without additional closure.

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Michal Spychalski, Prof. · Medical University of Lodz

  • Zofia Orzeszko, MD · Jagiellonian University in Cracow

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-01-10
Completion
2025-01-10

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779266 on ClinicalTrials.gov