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

December 8, 2021 updated by: Mr Christopher Halloran, University of Liverpool

PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

506

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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 anteriorly, tied.
Other Names:
  • Pancreatico-jejunostomy
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.
Other Names:
  • Sandostatin
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.
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.
Other Names:
  • Sandostatin
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.
Other Names:
  • Pancreatico-jejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of post-operative pancreatic fistula
Time Frame: Assessed up to 3 months after surgery.
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

Outcome Measure
Time Frame
Entry into programs of adjuvent therapy
Time Frame: 3, 6 and 12 month follow up
3, 6 and 12 month follow up
Mortality Rate
Time Frame: Death due to any cause during the study will be recorded
Death due to any cause during the study will be recorded
Rate of delayed gastric emptying
Time Frame: Post operative day 3, 5, 7, and the day of discharge, which is expected to be between 1 - 5 weeks after surgery.
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
Time Frame: 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
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
Time Frame: The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.
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
Time Frame: 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
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
Time Frame: Day of surgery
Day of surgery
Rate of intra and post-operative bleeding
Time Frame: 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
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
Time Frame: Up to 12 months after surgery
Up to 12 months after surgery
Rate of venous thrombo-embolism
Time Frame: 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
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
Time Frame: The day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
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
Time Frame: Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
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
Time Frame: Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up

Collaborators and Investigators

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

Sponsor

University of Liverpool

Collaborators

Cancer Research UK

Investigators

  • Principal Investigator: Christopher Halloran, University of Liverpool

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 Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 31, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL000732

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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