NCT00841607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

6.8 years

First QC Date

February 10, 2009

Last Update Submit

October 17, 2016

Conditions

Pancreas CancerPeriampullary Cancer

Keywords

whipplepancreasreconstructionleakfistula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • overall morbidity

    Up to POD 30

Study Arms (2)

Pancreaticojejunostomy

EXPERIMENTAL

Pancreaticojejunostomy reconstruction used following Whipple surgery.

Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

Pancreaticogastomy

ACTIVE COMPARATOR

Pancreaticogastomy reconstruction used following Whipple surgery.

Procedure: pancreaticojejunostomy vs pancreaticogastrostomy

Interventions

pancreaticojejunostomy vs pancreaticogastrostomyPROCEDURE
PancreaticogastomyPancreaticojejunostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4N2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 16845693BACKGROUND

  • 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.

    PMID: 25799130DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsFistula

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • elijah dixon, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Oncology and Community Health Sciences

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

August 1, 2006

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

CA(1)