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A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy

This study is currently recruiting participants.
Verified June 2013 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00359320
First received: August 1, 2006
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  Purpose

The purpose of this trial is to determine whether a mucosa-to-mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate.


Condition Intervention
Pancreatic Neoplasms
Biliary Tract Neoplasms
Pancreatitis, Chronic
Duodenal Neoplasms
 Procedure: pancreaticojejunostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • The primary endpoint will be the pancreatic fistula rate.

Secondary Outcome Measures:
  • length of hospitalization
  • percutaneous intervention rates
  • reoperation rates
  • morbidity
  • death

Study Start Date: July 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have undergone pancreaticoduodenectomy.
  • Must have pancreatic remnant remaining in place (body and tail).
  • Must be candidate for reconstruction by pancreaticojejunostomy by one of the two techniques described below.
  • Must have an identifiable pancreatic duct which can be used for a duct-to-mucosa anastomosis.

Exclusion Criteria:

  • Patients undergoing total pancreatectomy.
  • Patients undergoing PD who have had previous left-sided pancreatic resection.
  • Failure to sign informed consent.
  • Failure to identify the pancreatic duct.
  • Pregnant patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359320

Contacts
Contact: Adam C Berger, MD 215-955-1622 adam.berger@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sub-Investigator: Charles Yeo, MD            
Sub-Investigator: Eugene P Kennedy, MD            
Sub-Investigator: Ernest Rosato, MD            
Sub-Investigator: Karen Chojnacki, MD            
Sub-Investigator: Cataldo Doria, MD            
Sub-Investigator: Bernadette Profeta, MD            
Sub-Investigator: Patricia Sauter, CRNP            
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Adam C Berger, MD Thomas Jefferson University
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00359320     History of Changes
Obsolete Identifiers: NCT00432848
Other Study ID Numbers: 06U.198
Study First Received: August 1, 2006
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Pancreaticoduodenectomy
Pancreaticojejunostomy
Pancreatic Cancer

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Duodenal Neoplasms
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
 Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013