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

NCT06779266 | Completed

• 1 other identifier: 2025-0101
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Surgical Procedures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Delayed bleeding (DB) rate

  symptomatic bleeding occurring after the ESD procedure and within 28 days following the treatment. The symptoms included hematemesis, melena, and decrease in hemoglobin \>2g/dL.

  28 days

Secondary Outcomes (3)

• Overall Procedure Time (OPT)

  procedural

• Perforation Rate

  28 days

• Length of Hospital Stay (HS)

  28 days

Study Arms (3)

No closure

Participants who underwent endoscopic submucosal dissection without additional closure of the resection site.

Procedure: No closure

Sutured

Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope suturing.

Procedure: Suturing

Clipped

Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope clips.

Procedure: Clipping

Interventions

Suturing PROCEDURE

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.

Also known as: Endoscopic Hand Suturing, Endoscopic Through-the-scope Suturing

Sutured

Clipping PROCEDURE

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.

Also known as: Endoscopic Through-the-scope Suturing

Clipped

No closure PROCEDURE

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

No closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective study included all individuals who underwent gastric ESD from June 2015 to June 2024 in a single high-volume center and had an Eastern Cooperative Oncology Group performance status score of 0 or 1. All included procedures were performed in a conventional manner. The resection site was either left open, clipped, or sutured.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31061, Poland

Location

Related Publications (5)

• Jiang W, Cen L, Dong C, Zhu S, Shen Z, Li D. Prophylactic Clipping to Prevent Delayed Bleeding and Perforation After Endoscopic Submucosal Dissection and Endoscopic Mucosal Resection: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2022 Sep 1;56(8):643-653. doi: 10.1097/MCG.0000000000001721. Epub 2022 May 25.

  PMID: 35648969 BACKGROUND

• Goto O, Morita Y, Takayama H, Hirasawa K, Sato C, Oyama T, Takahashi A, Abe S, Saito Y, Ono H, Kawata N, Otsuka T, Iwakiri K. Endoscopic hand suturing has the potential to reduce bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic agents: Multicenter phase II study. Dig Endosc. 2025 Mar;37(3):266-274. doi: 10.1111/den.14911. Epub 2024 Aug 28.

  PMID: 39193787 BACKGROUND

• Jia Y, Zhai G, Wang E, Li P. Efficacy of local hemostatic agents after endoscopic submucosal dissection: a meta-analysis. Minim Invasive Ther Allied Technol. 2022 Oct;31(7):1017-1025. doi: 10.1080/13645706.2022.2111217. Epub 2022 Aug 24.

  PMID: 36000962 BACKGROUND

• Libanio D, Pimentel-Nunes P, Bastiaansen B, Bisschops R, Bourke MJ, Deprez PH, Esposito G, Lemmers A, Leclercq P, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, Fuccio L, Bhandari P, Dinis-Ribeiro M. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2023 Apr;55(4):361-389. doi: 10.1055/a-2031-0874. Epub 2023 Mar 7.

  PMID: 36882090 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Sutures

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Michal Spychalski, Prof.

  Medical University of Lodz

  STUDY CHAIR

• Zofia Orzeszko, MD

  Jagiellonian University in Cracow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: December 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

PL (1)