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

University of Liverpool

Status and phase: Unknown; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Octreotide; Procedure: Cattell-Warren Anastomosis; Procedure: Blumgart Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02457156

UoL000732

Details and patient eligibility

About

The purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.

Full description

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.

Enrollment: 506 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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506 participants in 2 patient groups

Blumgart Anastomosis

Experimental group

Description:

Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy. Octreotide will be administered.

Treatment:

Procedure: Blumgart Anastomosis

Drug: Octreotide

Cattell-Warren Anastomosis

Active Comparator group

Description:

Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy. Octreotide will be administered.

Treatment:

Procedure: Cattell-Warren Anastomosis

Drug: Octreotide