Clinical trial NCT06779266: Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.
Official title: Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Surgical Procedures
Keywords: Endoscopic Hand Suturing
Suturing Techniques
Endoscopic Submucosal Dissection
Gastrointestinal Bleeding
Endoscopic Closure Techniques
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 179
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: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delayed bleeding (DB) rate
timeFrame: 28 days
Secondary outcomes:
measure: Overall Procedure Time (OPT)
timeFrame: procedural
measure: Perforation Rate
timeFrame: 28 days
measure: Length of Hospital Stay (HS)
timeFrame: 28 days
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University
state: Lesser Poland
Study officials:
affiliation: Medical University of Lodz
name: Michal Spychalski, Prof.
role: STUDY_CHAIR
affiliation: Jagiellonian University in Cracow
name: Zofia Orzeszko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.