PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Trials
Christopher HalloranPaula Ghaneh

Abstract

Failure of the pancreatic remnant anastomosis to heal following pancreato-duodenectomy is a major cause of significant and life-threatening complications, notably a post-operative pancreatic fistula. Recently, non-randomized trials have shown superiority of a most intuitive anastomosis (Blumgart technique), which involves both a duct-to-mucosa and a full-thickness pancreatic "U" stitch, in effect a mattress stitch, over a standard duct-mucosa technique (Cattell-Warren). The aim of this study is to examine if these findings remain within a randomized setting. The PANasta trial is a randomized, double-blinded multi-center study, whose primary aim is to assess whether a Blumgart pancreatic anastomosis (trial intervention) is superior to a Cattell-Warren pancreatic anastomosis (control intervention), in terms of pancreatic fistula rates. Patients with suspected malignancy of the pancreatic head, in whom a pancreato-duodenectomy is recommended, would be recruited from several UK specialist regional centers. The hypothesis to be tested is that a Blumgart anastomosis will reduce fistula rate from 20 to 10 %. Subjects will be stratified by research site, pancreatic consistency and diameter of pancreatic duct; giving a sample size of 25...Continue Reading

References

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Citations

Jan 20, 2017·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Motokazu SugimotoMasaru Konishi
Dec 1, 2017·Khirurgiia·V I Egorov, R V Petrov
Jan 9, 2019·Nature Reviews. Clinical Oncology·Robert P JonesGraeme J Poston
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Jan 25, 2020·Langenbeck's Archives of Surgery·Marek OlakowskiSławomir Mrowiec
Apr 6, 2019·Indian Journal of Surgical Oncology·Mallika TewariH S Shukla
Jun 7, 2019·World Journal of Gastroenterology : WJG·Ya-Tong LiMeng-Hua Dai
Jan 31, 2020·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Riccardo CasadeiFrancesco Minni
Jun 23, 2020·Gastroenterology Research and Practice·Ricky H BhogalAamir Z Khan
Jan 29, 2021·Innovative Surgical Sciences·Georgi KalevThomas Schiedeck

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Methods Mentioned

BETA
pancreatectomy
contraception

Software Mentioned

Treatment Allocation Randomization System ( TARDIS )
ConDuCT II
SAS SEQDESIGN
PANasta

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