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

NCT02457156 | Completed Phase 3

• 1 other identifier: UoL000732
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatico-jejunostomy; Pancreato-duodenectomy; Cattell-Warren anastomosis; Blumgart anastomosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Entry into programs of adjuvent therapy

  3, 6 and 12 month follow up

• 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.

Study Arms (2)

Blumgart Anastomosis

EXPERIMENTAL

Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy. Octreotide will be administered.

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.

Procedure: Cattell-Warren Anastomosis; Drug: Octreotide

Interventions

Blumgart Anastomosis PROCEDURE

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.

Also known as: Pancreatico-jejunostomy

Blumgart Anastomosis

Cattell-Warren Anastomosis PROCEDURE

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.

Also known as: Pancreatico-jejunostomy

Cattell-Warren Anastomosis

Octreotide DRUG

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.

Also known as: Sandostatin

Blumgart Anastomosis; Cattell-Warren Anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• Cancer Research UK: collaborator

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Christopher Halloran

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: May 29, 2015
• Study Start: April 23, 2015
• Primary Completion: July 31, 2018
• Study Completion: January 31, 2019
• Last Updated: March 13, 2025

Record last verified: 2021-12

Locations

GB (1)