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

Pancreatic Cancer Clinical Trial

— PANasta  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02457156
• Other study ID #: UoL000732
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 506
• Est. completion date: December 2021
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Procedure:
• Blumgart Anastomosis
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 Anastomosis
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.

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.

Locations

Country	Name	City	State
United Kingdom	Royal Liverpool University Hospital	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
University of Liverpool	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed up to 3 months after surgery.
Secondary	Entry into programs of adjuvent therapy		3, 6 and 12 month follow up
Secondary	Mortality Rate		Death due to any cause during the study will be recorded
Secondary	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.
Secondary	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
Secondary	Rate of pulmonary infection		The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.
Secondary	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
Secondary	Operation time		Day of surgery
Secondary	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
Secondary	Rate of re-operation		Up to 12 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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