PANasta

• Research type

  Research Study

• Full title

  Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy - a double blinded multicentred trial.

• IRAS ID

  162472

• Contact name

  Christopher Halloran

• Contact email

  halloran@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This is a randomised controlled, phase 3, double blinded, multi-centre clinical trial comparing Cattell-Warren (CWA) vs. Blumgart (BA) methods of pancreatico-jejunostomy following pancreatic-duodenectomy 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 suregon:

  Arm A: Blumgart method of panreatico-jejunostomy.
  Arm B: Cattell-Warren method pf pancreatico-jejunostomy.

  This willbe undertaken intra-operatively, following pancreatic head axcision, just prior to pancreatic head remnan reconstruction.

  Patients will be assessed post operatively on days 3, 5, 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. Samples for the translational study will be taken subject to informed consent.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/1393

• Date of REC Opinion

  22 Dec 2014

• REC opinion

  Further Information Favourable Opinion