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

March 10, 2025 updated by: 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
295

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liverpool

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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