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

Study Overview

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

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.

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.

Pancreatic Cancer

PROCEDURE: Blumgart Anastomosis
PROCEDURE: Cattell-Warren Anastomosis
DRUG: Octreotide

UoL000732

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-10
First Submitted that Met QC Criteria 2015-05-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-13
First Posted (ACTUAL) 2015-05-29	Results First Posted N/A	Last Verified 2021-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Blumgart Anastomosis Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy. Octreotide will be administered.	PROCEDURE: 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 anterior DRUG: 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.
ACTIVE_COMPARATOR: Cattell-Warren Anastomosis Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy. Octreotide will be administered.	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. DRUG: 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Blumgart Anastomosis

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

PROCEDURE: 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 anterior

DRUG: 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.

ACTIVE_COMPARATOR: Cattell-Warren Anastomosis

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

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.

DRUG: 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.

Primary Outcome Measures	Measure Description	Time Frame
Presence or absence of post-operative pancreatic fistula	Post-operative pancreatic fistula are defined as any abnormal connection between the pancreatic duct epithelium and another epithelised surface, which contains pancreatic derived, enzyme rich fluid. This will be assessed up to 3 months following surgery on inpatient days 3-7, day of discharge (expected to be 1 - 5 weeks after surgery) and 3 month follow up.	Assessed up to 3 months after surgery.

Secondary Outcome Measures	Measure Description	Time Frame
Entry into programs of adjuvent therapy		3, 6 and 12 month follow up
Mortality Rate		Death due to any cause during the study will be recorded
Rate of delayed gastric emptying		Post operative day 3, 5, 7, and the day of discharge, which is expected to be between 1 - 5 weeks after surgery.
Rate of wound infections		Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3, 6 and 12 month follow up
Rate of pulmonary infection		The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.
Rate of post-operative fluid collections		post operative days 3-7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow-up
Operation time		Day of surgery
Rate of intra and post-operative bleeding		day of surgery, post operaive day 3, 5, 7 and the day of discharge, which is expected to be between 1 - 5 weeks after surgery
Rate of re-operation		Up to 12 months after surgery
Rate of venous thrombo-embolism		Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow up
Length of hospital stay		The day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
Quality of Life measured by the QLQ-C30 questionnaire		Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
Health economic evaluation measured by the EQ-5D questionnaire		Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cancer Research UK

Investigators

PRINCIPAL_INVESTIGATOR: Christopher Halloran, University of Liverpool

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record