Pancreatic CancerPhase 3PANastaNCT02457156
Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy
A Phase 3 study testing Blumgart Anastomosis, Cattell-Warren Anastomosis and Octreotide in people with Pancreatic Cancer, run by University of Liverpool at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Blumgart Anastomosis, Cattell-Warren Anastomosis and Octreotide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2015to 31 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
About this study
Official title: 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.
Read the 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
- Being tested
- Blumgart Anastomosis, Cattell-Warren Anastomosis, Octreotide
- Keywords
- Pancreatico-jejunostomy, Pancreato-duodenectomy, Cattell-Warren anastomosis, Blumgart anastomosis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blumgart AnastomosisProcedure or surgery
Also called Pancreatico-jejunostomy
- Trans pancreatic suture "U" stich incorporating pancreatic parenchyma and jejunal serosa, left loose.
- Pancreatic duct to jejunal mucosa sutures, inserted and tied.
- Trans pancreatic suture "U" stich brought back through the jejuanl serosa anteriorly, tied.
Cattell-Warren AnastomosisProcedure or surgery
Also called Pancreatico-jejunostomy
- Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.
- Pancreatic duct to jejunal mucosa sutures, inserted and tied.
- Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.
OctreotideDrug
Also called Sandostatin
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.
| Study group | Role | What they receive |
|---|---|---|
| Blumgart Anastomosis | Experimental | Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.
Octreotide will be administered. Receives: Procedure: Blumgart Anastomosis; Drug: Octreotide |
| Cattell-Warren Anastomosis | Active comparator | Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.
Octreotide will be administered. Receives: Procedure: Cattell-Warren Anastomosis; Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed up to 3 months after surgery.
Secondary outcomes (13)
Entry into programs of adjuvent therapy
Measured: 3, 6 and 12 month follow up
Mortality Rate
Measured: Death due to any cause during the study will be recorded
Rate of delayed gastric emptying
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day of surgery
Rate of intra and post-operative bleeding
Measured: 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
Measured: Up to 12 months after surgery
Rate of venous thrombo-embolism
Measured: 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
Measured: 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
Measured: 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
Measured: Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start23 Apr 2015
- Primary completion31 Jul 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Christopher Halloran, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457156
- Sponsor's protocol ID
- UoL000732
- Acronym
- PANasta
- Status last verified
- Dec 2021
- First submitted
- 5 Mar 2015
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial
- ClinicalTrials.gov ID
- NCT02457156
- Acronym / sponsor ID
- PANasta / UoL000732
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatico-jejunostomy, Pancreato-duodenectomy, Cattell-Warren anastomosis, Blumgart anastomosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blumgart Anastomosis | Experimental | Procedure: Blumgart Anastomosis, Drug: OctreotideRe-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy. Octreotide will be administered. |
| Cattell-Warren Anastomosis | Active comparator | Procedure: Cattell-Warren Anastomosis, Drug: OctreotideRe-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy. Octreotide will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients undergoing extended pancreato-duodenectomy
- Left, central or total pancreatectomy.
- Arterial resection or multi-visceral resection
- Previous pancreatic surgery
- Surgery for known chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blumgart AnastomosisAlso: Pancreatico-jejunostomy1. 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. | Procedure or surgery | Blumgart Anastomosis |
| Cattell-Warren AnastomosisAlso: Pancreatico-jejunostomy1. 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. | Procedure or surgery | Cattell-Warren Anastomosis |
| OctreotideAlso: SandostatinOctrotide (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. | Drug | Blumgart Anastomosis, Cattell-Warren Anastomosis |
Primary outcome
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.
13 secondary outcomes
Entry into programs of adjuvent therapy
Time frame: 3, 6 and 12 month follow up
Mortality Rate
Time frame: 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.
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
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.
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
Operation time
Time frame: 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
Rate of re-operation
Time frame: 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Halloran principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blumgart Anastomosis, Cattell-Warren Anastomosis and Octreotide in people with Pancreatic Cancer, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of post-operative pancreatic fistula (time frame: Assessed up to 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.