Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery for prevention of postpancreatectomy haemorrhage: Randomized clinical trial (PANDA trial)

Thilo Welsch, Benjamin Müssle, Sandra Korn, Dorothe Sturm, Ulrich Bork, Marius Distler, Xina Grählert, Anna Klimova, Nicole Trebesius, Axel Kleespies, Stefan Kees, Stefan Beckert, Daniel Reim, Helmut Friess, Malik Elwerr, Jörg Kleeff, Octavian Popescu, Hubertus Schmitz-Winnenthal, Monika Janot-Matuschek, Waldemar UhlGeorg F. Weber, Maximilian Brunner, Henriette Golcher, Robert Grützmann, Jürgen Weitz

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

Background: Postpancreatectomy haemorrhage (PPH) is a rare but potentially fatal complication after pancreatoduodenectomy. Preventive strategies are lacking with scarce data for support. The aim of this study was to investigate whether a prophylactic falciform ligament wrap around the hepatic and gastroduodenal artery can prevent PPH from these vessels. Methods: In a randomized, controlled, multicentre trial, patients who were scheduled for elective open partial pancreatoduodenectomy with pancreatojejunostomy between 5 November 2015 and 2 April 2020 were randomly allocated in a 1: 1 ratio to undergo pancreatoduodenectomy with (intervention) or without (control) a falciform ligament wrap around the hepatic artery. The primary endpoint was the rate of clinically relevant PPH from the hepatic artery or gastroduodenal artery stump within 3 months after pancreatoduodenectomy. Secondary endpoints were the rates of associated postoperative complications, for example postoperative pancreatic fistula (POPF) and PPH. Results: Altogether, 445 patients were randomized with 222 and 223 in each group. Among the patients included in modified intention-To-Treat analysis (207 in the intervention group and 210 in the control group), the primary endpoint was observed in six of 207 in the intervention group compared with 15 of 210 in the control group (2.9 versus 7.1 per cent respectively; odds ratio 0.39 (95 per cent c.i. 0.15 to 1.02); P = 0.071). Per protocol analysis showed a significant reduction in the intervention group (odds ratio 0.26 (95 per cent c.i. 0.09 to 0.80); P = 0.017). A soft pancreas texture (43 per cent) and the rate of a clinically relevant POPF were evenly (20 per cent) distributed between the groups. The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively). Conclusion: A falciform ligament wrap may reduce PPH from the hepatic artery or gastroduodenal artery stump and should be considered during pancreatoduodenectomy. Registration number: NCT02588066 (http://www.clinicaltrials.gov).

Original languageEnglish
Pages (from-to)37-45
Number of pages9
JournalBritish Journal of Surgery
Volume109
Issue number1
DOIs
StatePublished - 1 Jan 2022
Externally publishedYes

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