title: PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ISRCTN52263879 . Date of registration 15 January 2015.
authors.affiliation: National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Clinical Directorate of General Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust and the University of Liverpool, Liverpool, L69 3GA, UK. halloran@liverpool.ac.uk.|Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, The Duncan Building, Daulby Street, Liverpool, L69 3GA, UK. halloran@liverpool.ac.uk.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Halloran
authors.affiliation: Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK. kplatt@liverpool.ac.uk.
authors.forename: Kellie
authors.initials: K
authors.lastname: Platt
authors.affiliation: Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK. agerard@liverpool.ac.uk.
authors.forename: Abbie
authors.initials: A
authors.lastname: Gerard
authors.affiliation: Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK. polydorf@liverpool.ac.uk.
authors.forename: Fotis
authors.initials: F
authors.lastname: Polydoros
authors.affiliation: Department of Surgery, Manchester Royal Infirmary, Oxford Rd, Manchester, M13 9WL, UK. Derek.O'Reilly@cmft.nhs.uk.
authors.forename: Derek A
authors.initials: DA
authors.lastname: O'Reilly
authors.affiliation: Queen's Medical Center, Derby Road, Nottingham, NG7 2UH, UK. Dhanny.Gomez@nuh.nhs.uk.
authors.forename: Dhanwant
authors.initials: D
authors.lastname: Gomez
authors.affiliation: Department of Pancreatic Surgery, Abdominal Medicine and Surgery CSU, St James's University Hospital, 3rd Floor Bexley Wing, Leeds, LS9 7TF, UK. AndrewM.Smith@leedsth.nhs.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Smith
authors.affiliation: National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Clinical Directorate of General Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust and the University of Liverpool, Liverpool, L69 3GA, UK. johnyboy@liverpool.ac.uk.|Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK. johnyboy@liverpool.ac.uk.
authors.forename: John P
authors.initials: JP
authors.lastname: Neoptolemos
authors.affiliation: Churchill Hospital, Oxford University Hospitals NHS Trust, Headington, Oxford, OX3 7LJ, UK. Zahir.Soonawalla@ouh.nhs.uk.
authors.forename: Zahir
authors.initials: Z
authors.lastname: Soonwalla
authors.affiliation: Mater Hospital, Belfast Health and Social care Trust, Crumlin Rd, Belfast, BT12 6AB, UK. Mark.Taylor@belfasttrust.hscni.net.
authors.forename: Mark
authors.initials: M
authors.lastname: Taylor
authors.affiliation: Bristol Center for Surgical Research, School of Social and Community Medicine, University of Bristol, BS8 2PS and University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8HW, UK. J.M.Blazeby@bristol.ac.uk.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Clinical Directorate of General Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust and the University of Liverpool, Liverpool, L69 3GA, UK. paula@liverpool.ac.uk.|Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK. paula@liverpool.ac.uk.
authors.forename: Paula
authors.initials: P
authors.lastname: Ghaneh
mesh_terms: D000714:Anastomosis, Surgical / Q000379:methods*; D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D017063:Outcome Assessment, Health Care; D010179:Pancreas / Q000601:surgery*; D010190:Pancreatic Neoplasms / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D010193:Pancreaticojejunostomy / Q000379:methods*; D018401:Sample Size