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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreas Cancer, Periampullary Cancer

Intervention / Treatment
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* Procedure: pancreaticojejunostomy vs pancreaticogastrostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreaticojejunostomy<br>Pancreaticojejunostomy reconstruction used following Whipple surgery. | Procedure: pancreaticojejunostomy vs pancreaticogastrostomy<br> <br> |
| Active Comparator: Pancreaticogastomy<br>Pancreaticogastomy reconstruction used following Whipple surgery. | Procedure: pancreaticojejunostomy vs pancreaticogastrostomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic leak/fistula | 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. | Up to POD 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall morbidity | 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. | Up to POD 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whipple, pancreas, reconstruction, leak, fistula