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PANASTA   

Title

Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pacreato-duodenectomy – a double blinded multi-centred trial (Phase III).


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Recruitment
III Surgical Open UoL Eudract No:
Isrctn No: ISRCTN52263879
295

Trial Start Date

23/04/2015


Trial Coordinator

Celeste Abbott


Trial Coordinator Email Address

abbott@liverpool.ac.uk


Trial Coordinator Contact No

0151 794 8933


Website Treatment  

Patients will be randomised 1:1 to receive one of the two treatment arms, which are different methods of constructing a pancreatico-jejunostomy in the reconstruction of the pancreatic remnant following pancreato-duodenectomy.

Trial Endpoints  


Primary Outcome  

This is the presence or absence of a post-operative pancreatic fistula (POPF) as defined by Bassi et al. [14]. For the purpose of this study all classes of fistula will be recorded. POPF are defined as any abnormal connection between the pancreatic duct epithelium and another epithelised surface, which contains pancreatic derived, enzyme rich fluid. POPF need to satisfy the following criteria:
? Output of a measurable volume of fluid via either a drain placed per-operatively or via subsequent placed interventional drain.
? On or after post-operative day 3
? Amylase content greater than 3 times the institutional upper limit of normal.


Secondary Outcomes  

  • Entry into programs of adjuvant therapy/clinical trials of adjuvant therapy
  • Mortality rate
  • Pancreas specific complications
  • Non-Pancreas specific complications
  • Assessment of quality of life
  • Health economic evaluation

Eligibility  

 Inclusion Criteria
Subjects meeting all of the following criteria will be considered for this trial:
? Patients undergoing an elective pancreato-duodenectomy for presumed malignancy.
? Ability of the subject to understand the nature and consequences of the trial.
? Ability to provide written informed consent.


Exclusion Criteria
Subjects with the following criteria will not be entered into this trial:
? Patients undergoing extended pancreato-duodenectomy
? Left, central or total pancreatectomy
? Arterial resection or multi-visceral resection
? Previous pancreatic resection
? Surgery for known chronic pancreatitis
? Recruited to any other pancreatic resection trial.
? Pregnant women


UK: ENGLAND

  • , Churchill Hospital (Oxford) (Srikanth Reddy)
  • , Queen's Medical Centre (Nottingham) (Dhanny Gomez)
  • Leeds, St. James University Hospital (Leeds) (Andrew Smith)
  • Liverpool, Royal Liverpool University Hospital (Christopher Halloran)
  • London, King's College Hospital (London) (Andreas Prachalias)

UK: England

  • London, Royal Free Hospital (London) (Brian Davidson)
  • Manchester , Manchester Royal Infirmary (Derek O'Reilly)

UK: Wales

  • Swansea, Morriston Hospital (Swansea) (Bilal Al-Sarireh)

UK: N. IRELAND

  • , Mater Infirmorium Hospital (Belfast) (Mark Taylor)

UK: SCOTLAND

  • , Aberdeen Royal Infirmary (Irfan Ahmed)