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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841607
First Posted: February 11, 2009
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
MSI Foundation
University of Calgary
Canadian Association of General Surgeons
Information provided by (Responsible Party):
Elijah Dixon, Tom Baker Cancer Centre
  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
Intervention Model: Parallel Assignment
Masking: None (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 Elijah Dixon, Tom Baker Cancer Centre:

Primary Outcome Measures:
  • pancreatic leak/fistula [ Time Frame: Up to POD 10 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 10, 2009
First Posted: February 11, 2009
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Elijah Dixon, 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