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

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ClinicalTrials.gov Identifier: NCT00841607
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
MSI Foundation
University of Calgary
Canadian Association of General Surgeons
Information provided by (Responsible Party):
Elijah Dixon, Tom Baker Cancer Centre

February 10, 2009
February 11, 2009
October 18, 2016
August 2006
May 2013   (Final data collection date for primary outcome measure)
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.
pancreatic leak/fistula
Complete list of historical versions of study NCT00841607 on ClinicalTrials.gov Archive Site
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.
overall morbidity
Not Provided
Not Provided
 
Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy
Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreas Cancer
  • Periampullary Cancer
Procedure: pancreaticojejunostomy vs pancreaticogastrostomy
  • Experimental: Pancreaticojejunostomy
    Pancreaticojejunostomy reconstruction used following Whipple surgery.
    Intervention: Procedure: pancreaticojejunostomy vs pancreaticogastrostomy
  • Active Comparator: Pancreaticogastomy
    Pancreaticogastomy reconstruction used following Whipple surgery.
    Intervention: Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
320
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00841607
18982
Not Provided
Not Provided
Not Provided
Elijah Dixon, Tom Baker Cancer Centre
Tom Baker Cancer Centre
  • MSI Foundation
  • University of Calgary
  • Canadian Association of General Surgeons
Principal Investigator: elijah dixon, MD University of Calgary
Tom Baker Cancer Centre
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP