Clinical trial NCT06622746: Endoscopic Hand Suturing After Advanced Endoscopic Resections.
Official title: Endoscopic Hand Suturing After Advanced Endoscopic Resections - Early Outcomes of 31 Cases in Upper and Lower GI Tract.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Surgical Procedures
Keywords: Endoscopic Hand Suturing
Suturing Techniques
Endoscopic Submucosal Dissection
Submucosal Tunneling Endoscopic Resection
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Suturing time
timeFrame: From 1st of March 2023 to 30th of July 2024.
measure: Suturing speed
timeFrame: From 1st of March 2023 to 30th of July 2024.
Secondary outcomes:
measure: Postprocedural bleeding rate
timeFrame: From 1st of March 2023 to 30th of July 2024.
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: Jagiellonian University
state: Lesser Poland
Study officials:
affiliation: Center of Bowel Treatment
name: Michal Spychalski, PhD
role: STUDY_CHAIR
affiliation: Jagiellonian University in Cracow
name: Zofia Orzeszko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.