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

NCT ID: NCT00841607

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2013-05-31

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.

Conditions

Pancreas Cancer; Periampullary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pancreaticojejunostomy

Pancreaticojejunostomy reconstruction used following Whipple surgery.

Group Type: EXPERIMENTAL

pancreaticojejunostomy vs pancreaticogastrostomy

Intervention Type: PROCEDURE

Pancreaticogastomy

Pancreaticogastomy reconstruction used following Whipple surgery.

Group Type: ACTIVE_COMPARATOR

pancreaticojejunostomy vs pancreaticogastrostomy

Intervention Type: PROCEDURE

Interventions

pancreaticojejunostomy vs pancreaticogastrostomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• female subjects who are pregnant or nursing
• current use of an investigational drug
• currently receiving chemotherapy or radiotherapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MSI Foundation

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: collaborator

Canadian Association of General Surgeons

OTHER

Sponsor Role: collaborator

Tom Baker Cancer Centre

OTHER

Sponsor Role: lead

Responsible Party

Elijah Dixon

Professor of Surgery, Oncology and Community Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

elijah dixon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

References

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. doi: 10.1002/bjs.5407.

Reference Type: BACKGROUND

PMID: 16845693 (View on PubMed)

Grendar J, Ouellet JF, Sutherland FR, Bathe OF, Ball CG, Dixon E. In search of the best reconstructive technique after pancreaticoduodenectomy: pancreaticojejunostomy versus pancreaticogastrostomy. Can J Surg. 2015 Jun;58(3):154-9. doi: 10.1503/cjs.010014.

Reference Type: DERIVED

PMID: 25799130 (View on PubMed)

Other Identifiers

18982

Identifier Type: -

Identifier Source: org_study_id