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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841607
• Other study ID #: 18982
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: October 17, 2016
• Start date: August 2006
• Est. completion date: May 2013

Study information

• Verified date: October 2016
• Source: Tom Baker Cancer Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms
• Periampullary Cancer

Intervention

Procedure:
• pancreaticojejunostomy vs pancreaticogastrostomy

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
Tom Baker Cancer Centre	Canadian Association of General Surgeons, MSI Foundation, University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

McKay A, Mackenzie S, Sutherland FR, Bathe OF, Doig C, Dort J, Vollmer CM Jr, Dixon E. Meta-analysis of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy. Br J Surg. 2006 Aug;93(8):929-36. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No