Endoscopic Hand Suturing After Advanced Endoscopic Resections.

NCT06622746 | Completed DMC

• 1 other identifier: 2024.000.586
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes.

Conditions

Endoscopic Surgical Procedures

Keywords

Endoscopic Hand Suturing; Suturing Techniques; Endoscopic Submucosal Dissection; Submucosal Tunneling Endoscopic Resection

Outcome Measures

Primary Outcomes (2)

• Suturing time

  The time between delivering and retrieving the needle, in minutes.

  From 1st of March 2023 to 30th of July 2024.

• Suturing speed

  Calculated by dividing the longitudinal length of the defect in millimeters by the suturing time in minutes.

  From 1st of March 2023 to 30th of July 2024.

Secondary Outcomes (1)

• Postprocedural bleeding rate

  From 1st of March 2023 to 30th of July 2024.

Study Arms (1)

EHS

All individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024

Procedure: Endoscopic Hand Suturing

Interventions

Endoscopic Hand Suturing PROCEDURE

Endoscopic Hand Suturing is a technique of the wound closure after advanced endoscopic third-space resections I 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.

EHS

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

This retrospective single-center study included all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024. Procedures were conducted both in the upper and lower GI tract and included endoscopic intermuscular dissection (EID), endoscopic mucosal resection (EMR), ESD, EFTR, POEM, and STER. The EHS was performed to close a GI wall defect (after EMR, ESD, or EID) or the linear entry mucosal incision (after POEM or STER). The indications for additional suturing were high risk of bleeding following ESD in upper GI (based on patients' history of anticoagulant therapy and advanced age), closing the deep wall defect after EID in the rectum to improve recovery, closing the full-thickness defect after EFTR in cases of submucosal lesions, and concurrent treatment for perforation during ESD.

You may qualify if:

• all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024.

You may not qualify if:

• none

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31007, Poland

Location

Related Publications (5)

• Goto O, Oyama T, Ono H, Takahashi A, Fujishiro M, Saito Y, Abe S, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand-suturing is feasible, safe, and may reduce bleeding risk after gastric endoscopic submucosal dissection: a multicenter pilot study (with video). Gastrointest Endosc. 2020 May;91(5):1195-1202. doi: 10.1016/j.gie.2019.12.046. Epub 2020 Jan 7.

  PMID: 31923410 BACKGROUND

• Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Takatori Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy. Dig Endosc. 2022 Jan;34(1):123-132. doi: 10.1111/den.14045. Epub 2021 Jun 22.

  PMID: 34021512 BACKGROUND

• Uozumi T, Abe S, Mizuguchi Y, Sekiguchi M, Toyoshima N, Takamaru H, Yamada M, Kobayashi N, Sadachi R, Ito S, Takada K, Kishida Y, Imai K, Hotta K, Ono H, Saito Y. Endoscopic hand suturing using a modified through-the-scope needle holder for mucosal closure after colorectal endoscopic submucosal dissection: Prospective multicenter study (with video). Dig Endosc. 2024 Nov;36(11):1245-1252. doi: 10.1111/den.14808. Epub 2024 May 22.

  PMID: 38775419 BACKGROUND

• Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic suturing promotes healing of mucosal defects after gastric endoscopic submucosal dissection: endoscopic and histologic analyses in in vivo porcine models (with video). Gastrointest Endosc. 2020 May;91(5):1172-1182. doi: 10.1016/j.gie.2019.12.032. Epub 2020 Jan 3.

  PMID: 31904381 BACKGROUND

• Abe S, Saito Y, Tanaka Y, Ego M, Yanagisawa F, Kawashima K, Takamaru H, Sekiguchi M, Yamada M, Sakamoto T, Matsuda T, Goto O, Yahagi N. A novel endoscopic hand-suturing technique for defect closure after colorectal endoscopic submucosal dissection: a pilot study. Endoscopy. 2020 Sep;52(9):780-785. doi: 10.1055/a-1120-8533. Epub 2020 Mar 23.

  PMID: 32207119 BACKGROUND

Study Officials

• Michal Spychalski, PhD

  Center of Bowel Treatment

  STUDY CHAIR

• Zofia Orzeszko, PhD

  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: MD

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: April 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

PL (1)