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Title:Influence of pancreas transection with cavitron ultrasonic surgical aspirator (CUSA) on incidence of postoperative pancreatic fistula after pancreatoduodenectomy (PANCUT) : study protocol for a randomised controlled trial
Authors:ID Hadžialjević, Benjamin (Author)
ID Zavrtanik Čarni, Hana (Author)
ID Petrič, Miha (Author)
ID Djokić, Mihajlo (Author)
ID Trotovšek, Blaž (Author)
ID Tomažič, Aleš (Author)
ID Badovinac, David (Author)
Files:.pdf PDF - Presentation file, download (1,48 MB)
MD5: AAE5DD181ACE444BDF58E338CCD11366
 
URL URL - Source URL, visit https://link.springer.com/article/10.1186/s13063-025-08898-4
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo UKC LJ - Ljubljana University Medical Centre
Abstract:Background: Complications after pancreatoduodenectomy occur in up to 40% of patients. Postoperative pancreatic fistula (POPF) remains the most common complication after pancreatoduodenectomy and is associated with increased postoperative mortality. The cavitron ultrasonic surgical aspirator (CUSA) is a surgical instrument commonly used in liver and neurosurgery. The CUSA selectively dissects tissue parenchyma, leaving blood vessels and bile ducts undamaged, which are then selectively ligated or clipped. Only a few studies have investigated the relationship between the transection of pancreatic tissue with CUSA and the formation of POPF. The results were inconsistent and were published before the updated ISGPS consensus on the definition of POPF. Methods: The PANCUT study is a randomised controlled trial initiated at the Department of Abdominal Surgery, University Medical Centre Ljubljana. The aim of the study is to determine whether precise dissection of the pancreatic tissue with CUSA reduces the incidence of POPF. Patients scheduled for pancreatoduodenectomy will be randomly assigned to either the experimental group, in which the pancreatic tissue will be dissected with CUSA, or the control group, in which pancreas will be conventionally transected with scalpel. A total of 180 patients will be included in the study. The primary endpoint is the formation of POPF. Secondary endpoints include operation time, amount of intraoperative blood loss, postoperative infectious complications, postoperative bleeding, length of hospital stay and mortality. Discussion: To our knowledge, the PANCUT study is the first randomized controlled trial to investigate the role of CUSA in the transection of pancreatic tissue during pancreatoduodenectomy. Trial registration: ClinicalTrials.gov NCT06135012. Registered on 18 November 2023.
Keywords:pancreatic fistula, postoperative complications, pancreas resection, cusa, pancreatoduodenectomy, pancreatic ducts
Publication status:Published
Publication version:Version of Record
Year of publishing:2025
Number of pages:str. 1-8
Numbering:Vol. 26, issue 1, [article no.] 190
PID:20.500.12556/DiRROS-24400 New window
UDC:616
ISSN on article:1745-6215
DOI:10.1186/s13063-025-08898-4 New window
COBISS.SI-ID:243297027 New window
Note:Nasl. z nasl. zaslona; Opis vira z dne 22. 7. 2025;
Publication date in DiRROS:26.11.2025
Views:182
Downloads:121
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Record is a part of a journal

Title:Trials
Publisher:BioMed Central
ISSN:1745-6215
COBISS.SI-ID:514082073 New window

Document is financed by a project

Funder:Other - Other funder or multiple funders
Funding programme:Univerzitetni klinični center Ljubljana
Project number:20230052
Name:Vpliv disekcije trebušne slinavke s kavitacijskim ultrazvočnim sistemom za aspiracijo (CUSA) na pojavnost pooperativne pankreatične fistule - prospektivna randomizirana kontrolirana raziskava: PANCUT

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License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

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