Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus. Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.

The primary objective of the trial is to establish if the Blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs.

506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the United Kingdom.

Patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon:

Arm A: Blumgart method of panreaticojejunostomy. Arm B: CattellWarren method pf pancreaticojejunostomy.

Randomisation will be undertaken intra-operatively, following pancreatic head excision, just prior to pancreatic head remnant reconstruction.

Patients will be assessed post operatively on days 3 to 7 and on day of dishcharge from hospital. Patients will continue to be followed up in the outpatient setting at 3, 6 and 12 months post surgery.

All laboratory and physical assessments performed will be in line standard care.

Blood samples for the translational study will be taken subject to informed consent pre-operatively and post-operatively 5 days after surgery.

A histological (H&E stained) slide of the pancreatic transection margin should be taken as routine. This will be requested from each patient for central pathology review to assess the amount of fibrosis.

Inclusion criteria

• Patients undergoing an elective pancreato-duodenectomy for presumed malignancy.
• Ability of the subject to understand the nature and consequences of the trial.
• Ability to rovide writen informed consent.
• Age 18 or greater.

Exclusion criteria

• Patients undergoing extended pancreato-duodenectomy
• Left, central or total pancreatectomy.
• Arterial resection or multi-visceral resection
• Previous pancreatic surgery
• Surgery for known chronic pancreatitis.
• Recruited to any other pancreatic resection trial.
• Pregnant women.
• Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from time of consent up to the day of surgery.