Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.
NCT ID: NCT06779266
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
179 participants
OBSERVATIONAL
2024-12-01
2025-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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No closure
Participants who underwent endoscopic submucosal dissection without additional closure of the resection site.
No closure
The resection site after endoscopic submucosal dissection was left open, without additional closure.
Sutured
Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope suturing.
Suturing
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.
Clipped
Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope clips.
Clipping
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.
Interventions
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Suturing
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.
Clipping
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.
No closure
The resection site after endoscopic submucosal dissection was left open, without additional closure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status score of 0 or 1
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Zofia Orzeszko
Principal Investigator
Principal Investigators
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Michal Spychalski, Prof.
Role: STUDY_CHAIR
Medical University of Lodz
Zofia Orzeszko, MD
Role: PRINCIPAL_INVESTIGATOR
Jagiellonian University in Cracow
Locations
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Jagiellonian University
Krakow, Lesser Poland Voivodeship, Poland
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2025-0101
Identifier Type: -
Identifier Source: org_study_id
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