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

This study has been completed.
Sponsor:
Collaborators:
MSI Foundation
University of Calgary
Canadian Association of General Surgeons
Information provided by (Responsible Party):
Elijah Dixon, Tom Baker Cancer Centre
ClinicalTrials.gov Identifier:
NCT00841607
First received: February 10, 2009
Last updated: October 17, 2016
Last verified: October 2016
  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 [ Time Frame: Up to POD 10 ] [ Designated as safety issue: No ]
    Either a radiologically proved anastomotic leak or the continued drainage (via drain, enterocutaneous fistula, or wound) of amylase (or lipase) rich fluid on or after postoperative day 10. This is a clinically relevant definition which has been used in many other reports.


Secondary Outcome Measures:
  • overall morbidity [ Time Frame: Up to POD 30 ] [ Designated as safety issue: No ]
    We will use the definition and classification of complications resulting from surgery as put forth by Clavien et al which has been widely adopted in the surgical literature.


Enrollment: 162
Study Start Date: August 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pancreaticojejunostomy
Pancreaticojejunostomy reconstruction used following Whipple surgery.
Procedure: pancreaticojejunostomy vs pancreaticogastrostomy
Active Comparator: Pancreaticogastomy
Pancreaticogastomy reconstruction used following Whipple surgery.
Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841607

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elijah Dixon, Professor of Surgery, Oncology and Community Health Sciences, Tom Baker Cancer Centre
ClinicalTrials.gov Identifier: NCT00841607     History of Changes
Other Study ID Numbers: 18982 
Study First Received: February 10, 2009
Last Updated: October 17, 2016
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016