Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Tom Baker Cancer Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
MSI Foundation
University of Calgary
Canadian Association of General Surgeons Research Grant
Information provided by:
Tom Baker Cancer Centre
ClinicalTrials.gov Identifier:
NCT00841607
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. The primary cause of complications following PD is related to leak occurring at this connection. Of patients that develop a leak, over half need a second operation, and up to 40% will die. The two main organs that the pancreas may be re-connected to are the jejunum or the stomach. The investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following PD. The goal of this study is to determine which of these methods is safer. The results may change practice patterns across North America and the world. It may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. This will therefore reduce the morbidity and mortality of this group of cancer patients.


Condition Intervention
Pancreas Cancer
Periampullary Cancer
Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy

Resource links provided by NLM:


Further study details as provided by Tom Baker Cancer Centre:

Primary Outcome Measures:
  • pancreatic leak/fistula

Secondary Outcome Measures:
  • overall morbidity

Estimated Enrollment: 320
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected pancreatic or periampullary neoplasm that appears to be resectable based on preoperative imaging (CT scan and/or MRI) and are deemed medically fit to undergo PD.

Exclusion Criteria:

  • Patients less than 18 years of age will be excluded.
  • As well, patients with distant metastasis, local unresectability, and/or gastric involvement will be excluded.

Other exclusion criteria include:

  • female subjects who are pregnant or nursing
  • current use of an investigational drug
  • currently receiving chemotherapy or radiotherapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841607

Contacts
Contact: elijah dixon, md 403 521 3169 elijah.dixon@calgaryhealthregion.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4N2
Principal Investigator: elijah Dixon, MD         
Sponsors and Collaborators
Tom Baker Cancer Centre
MSI Foundation
University of Calgary
Canadian Association of General Surgeons Research Grant
Investigators
Principal Investigator: elijah dixon, MD University of Calgary
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00841607     History of Changes
Other Study ID Numbers: 18982
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Tom Baker Cancer Centre:
whipple
pancreas
reconstruction
leak
fistula

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014