Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy
Recruitment status was Recruiting
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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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: elijah dixon, md | 403 521 3169 | elijah.dixon@calgaryhealthregion.ca |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N4N2 | |
| Principal Investigator: elijah Dixon, MD | |
| 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 May 23, 2013