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

J

Jagiellonian University

Status

Completed

Conditions

Endoscopic Surgical Procedures

Treatments

Procedure: Clipping
Procedure: Suturing
Procedure: No closure

Study type

Observational

Funder types

Other

Identifiers

NCT06779266
2025-0101

Details and patient eligibility

About

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.

Full description

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. The retrospective single-center study included individuals who underwent endoscopic submucosal dissection in the stomach. The resection site was either left open, clipped, or sutured. The study evaluated the overall procedure time (OPT), bleeding rate (BR), perforation rate, and length of hospital stay (HS). The assessment was conducted to compare the outcomes of "non-sutured vs. sutured" "no closure vs. closure" and "clipped vs. sutured" along with the propensity score matching analysis for reducing a potential selection bias.

Enrollment

179 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • underwent gastric ESD from June 2015 to June 2024
  • Eastern Cooperative Oncology Group performance status score of 0 or 1

Exclusion criteria

  • none

Trial design

179 participants in 3 patient groups

No closure
Description:
Participants who underwent endoscopic submucosal dissection without additional closure of the resection site.
Treatment:
Procedure: No closure
Sutured
Description:
Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope suturing.
Treatment:
Procedure: Suturing
Clipped
Description:
Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope clips.
Treatment:
Procedure: Clipping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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