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Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage

Authors :
Benjamin Müssle
Nuh N. Rahbari
Xina Grählert
Leonie Zühlke
Dorothée Sturm
Marius Distler
Thilo Welsch
Ann Wierick
Jürgen Weitz
Source :
Trials, Vol 19, Iss 1, Pp 1-7 (2018), Trials
Publication Year :
2018
Publisher :
BMC, 2018.

Abstract

Background The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD). Methods/design This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic wrapping of the GDA stump using the pedicled falciform ligament. The control group consists of 200 patients without the wrap. The primary endpoint is the rate of postoperative erosion hemorrhage of the GDA stump or hepatic artery within 3 months. The secondary endpoints are postpancreatectomy hemorrhage stratified according to the texture of the pancreas, postoperative pancreatic fistula (POPF), postoperative rate of therapeutic interventions, morbidity, and mortality. Discussion Only few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6–9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefore, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statistical significance. Trial registration clinicaltrials.gov, NCT02588066; Registered on 27 October 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2580-0) contains supplementary material, which is available to authorized users.

Details

Language :
English
ISSN :
17456215
Volume :
19
Issue :
1
Database :
OpenAIRE
Journal :
Trials
Accession number :
edsair.doi.dedup.....0f0cc0323018d4bfad7e93e0d7641fdf
Full Text :
https://doi.org/10.1186/s13063-018-2580-0