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

NCT ID: NCT02457156

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-23
• Study Completion Date: 2019-01-31

Brief Summary

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.

Detailed 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Blumgart Anastomosis

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

Octreotide will be administered.

Group Type: EXPERIMENTAL

Blumgart Anastomosis

Intervention Type: PROCEDURE

1. Trans pancreatic suture "U" stich incorporating pancreatic parenchyma and jejunal serosa, left loose.

2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.

3. Trans pancreatic suture "U" stich brought back through the jejuanl serosa anteriorly, tied.

Octreotide

Intervention Type: DRUG

Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.

Cattell-Warren Anastomosis

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

Octreotide will be administered.

Group Type: ACTIVE_COMPARATOR

Cattell-Warren Anastomosis

Intervention Type: PROCEDURE

1. Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.

2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.

3. Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.

Octreotide

Intervention Type: DRUG

Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.

Interventions

Blumgart Anastomosis

1. Trans pancreatic suture "U" stich incorporating pancreatic parenchyma and jejunal serosa, left loose.

2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.

3. Trans pancreatic suture "U" stich brought back through the jejuanl serosa anteriorly, tied.

Intervention Type: PROCEDURE

Cattell-Warren Anastomosis

1. Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.

2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.

3. Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.

Intervention Type: PROCEDURE

Octreotide

Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.

Intervention Type: DRUG

Other Intervention Names

Pancreatico-jejunostomy; Pancreatico-jejunostomy; Sandostatin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Halloran

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Royal Liverpool University Hospital

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Other Identifiers

UoL000732

Identifier Type: -

Identifier Source: org_study_id