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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06779266
Enrollment
179
Registered
2025-01-16
Start date
2024-12-01
Completion date
2025-01-10
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Surgical Procedures

Keywords

Endoscopic Hand Suturing, Suturing Techniques, Endoscopic Submucosal Dissection, Gastrointestinal Bleeding, Endoscopic Closure Techniques

Brief 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.

Detailed 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.

Interventions

PROCEDURESuturing

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.

PROCEDUREClipping

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.

PROCEDURENo closure

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Delayed bleeding (DB) rate28 dayssymptomatic bleeding occurring after the ESD procedure and within 28 days following the treatment. The symptoms included hematemesis, melena, and decrease in hemoglobin \>2g/dL.

Secondary

MeasureTime frameDescription
Overall Procedure Time (OPT)proceduralMeasured in minutes and based on the procedural protocol.
Perforation Rate28 daysDefined as post-procedural clinical signs of peritonitis with radiological signs of air in the peritoneal cavity.
Length of Hospital Stay (HS)28 daysThe time from the procedure to the discharge measured in days and based on the hospital database.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026