PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Liverpool
- Enrollment
- 295
- Locations
- 1
- Primary Endpoint
- Presence or absence of post-operative pancreatic fistula
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Blumgart Anastomosis
Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.
Octreotide will be administered.
Intervention: Blumgart Anastomosis (Procedure)
Blumgart Anastomosis
Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.
Octreotide will be administered.
Intervention: Octreotide (Drug)
Cattell-Warren Anastomosis
Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.
Octreotide will be administered.
Intervention: Cattell-Warren Anastomosis (Procedure)
Cattell-Warren Anastomosis
Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.
Octreotide will be administered.
Intervention: Octreotide (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Operation time(Day of surgery)
- 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.)
- Entry into programs of adjuvent therapy(3, 6 and 12 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)
- 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)