Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pacreato-duodenectomy – a double blinded multi-centred trial (Phase III).
|III||Surgical||Open||UoL|| Eudract No:
Isrctn No: ISRCTN52263879
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.
This is the presence or absence of a post-operative pancreatic fistula (POPF) as defined by Bassi et al. . 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.
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.
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
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