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

Not Applicable

Completed

• Conditions: Pancreas Cancer; Periampullary Cancer
• Interventions: Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

• Registration Number: NCT00841607
• Lead Sponsor: Tom Baker Cancer Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreaticojejunostomy	pancreaticojejunostomy vs pancreaticogastrostomy	Pancreaticojejunostomy reconstruction used following Whipple surgery.
Pancreaticogastomy	pancreaticojejunostomy vs pancreaticogastrostomy	Pancreaticogastomy reconstruction used following Whipple surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada