Clinical trial NCT02457156: Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy
Official title: PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Pancreatico-jejunostomy
Pancreato-duodenectomy
Cattell-Warren anastomosis
Blumgart anastomosis
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2015-05-29
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence or absence of post-operative pancreatic fistula
timeFrame: Assessed up to 3 months after surgery.
Secondary outcomes:
measure: Entry into programs of adjuvent therapy
timeFrame: 3, 6 and 12 month follow up
measure: Mortality Rate
timeFrame: Death due to any cause during the study will be recorded
measure: Rate of delayed gastric emptying
timeFrame: Post operative day 3, 5, 7, and the day of discharge, which is expected to be between 1 - 5 weeks after surgery.
measure: Rate of wound infections
timeFrame: 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
measure: Rate of pulmonary infection
timeFrame: The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.
measure: Rate of post-operative fluid collections
timeFrame: 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
measure: Operation time
timeFrame: Day of surgery
measure: Rate of intra and post-operative bleeding
timeFrame: 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
measure: Rate of re-operation
timeFrame: Up to 12 months after surgery
measure: Rate of venous thrombo-embolism
timeFrame: 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
measure: Length of hospital stay
timeFrame: The day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
measure: Quality of Life measured by the QLQ-C30 questionnaire
timeFrame: Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
measure: Health economic evaluation measured by the EQ-5D questionnaire
timeFrame: Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Christopher Halloran
role: PRINCIPAL_INVESTIGATOR
References: