Blazeby, Jane M

Gerard, Abbie

Ghaneh, Paula

Gomez, Dhanwant

Halloran, Christopher M

Neoptolemos, John P

O'Reilly, Derek A

Platt, Kellie

Polydoros, Fotis

Smith, Andrew

Soonwalla, Zahir

Taylor, Mark

Trials

PubMed

Christopher M. Halloran

Kellie Platt

Abbie Gerard

Fotis Polydoros

Derek A. O’Reilly

Dhanwant Gomez

Andrew Smith

John P. Neoptolemos

Zahir Soonwalla

Mark Taylor

Jane M. Blazeby

Paula Ghaneh

Crossref

English

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

BackgroundFailure 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.Methods/designThe 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 253 per group. The primary outcome measure is fistula rate at the pancreatico-jejunostomy. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay, cancer-specific quality of life and health economic assessments. Enrolled patients will undergo pancreatic resection and be randomized immediately prior to pancreatic reconstruction. The operation note will only record "anastomosis constructed as per PANasta trial randomization," thus the other members of the trial team and patient are blinded. An inbuilt internal pilot study will assess the ability to randomize patients, while the construction of an operative manual and review of operative photographs will maintain standardization of techniques.DiscussionThe PANasta trial will be the first multi-center randomized controlled trial (RCT) comparing two types of duct-to-mucosa pancreatic anastomosis with surgical quality assurance.Trial registrationISRCTN52263879 . Date of registration 15 January 2015

University of Liverpool Repository

Christopher Halloran (3484877)

Kellie Platt (3484886)

Abbie Gerard (3484880)

Fotis Polydoros (3484874)

Derek OâReilly (3484889)

Dhanwant Gomez (3484871)

Andrew Smith (11197)

John Neoptolemos (171598)

Zahir Soonwalla (3484868)

Mark Taylor (65647)

Jane Blazeby (644944)

Paula Ghaneh (294573)

The Francis Crick Institute

Additional file 1: of PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

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

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University of Liverpool Repository

The Francis Crick Institute

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