Pancreas Cancer, Periampullary Cancer
Conditions
Keywords
whipple, pancreas, reconstruction, leak, fistula
Brief summary
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.
Interventions
PROCEDUREpancreaticojejunostomy vs pancreaticogastrostomy
Sponsors
MSI Foundation
University of Calgary
Canadian Association of General Surgeons
Tom Baker Cancer Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pancreatic leak/fistula | 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
| Measure | Time frame | Description |
|---|---|---|
| overall morbidity | 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. |
Countries
Canada
Outcome results
None listed