Endoscopic Hand Suturing After Advanced Endoscopic Resections.

Endoscopic Hand Suturing After Advanced Endoscopic Resections - Early Outcomes of 31 Cases in Upper and Lower GI Tract.

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Surgical Procedures
• Intervention / Treatment: Procedure: Endoscopic Hand Suturing

Detailed Description

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. The retrospective single-center study included individuals that underwent advanced endoscopic procedures in upper and lower GI tract followed by EHS. Defined features (suturing time, suturing speed) and outcomes (postprocedural bleeding, abdominal pain) were assessed. Thirty-one patients were included in the analysis.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Poland
  • Lesser Poland
    • Cracovia, Lesser Poland, Poland, 31007
      • Jagiellonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: Endoscopic Hand Suturing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprocedural bleeding rate	The prevalence of the symptoms of gastrointestinal bleeding.	From 1st of March 2023 to 30th of July 2024.

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Michal Spychalski, PhD, Center of Bowel Treatment; Principal Investigator: Zofia Orzeszko, PhD, Jagiellonian University in Cracow

Publications and helpful links

General Publications

• 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.
• 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.
• 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 May 22. doi: 10.1111/den.14808. Online ahead of print.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic Submucosal Dissection; Endoscopic Hand Suturing; Suturing Techniques; Submucosal Tunneling Endoscopic Resection
• Other Study ID Numbers: 2024.000.586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We intend to share the encrypted data with other investigators after appropriate application and approval of the study chair.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No