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

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ClinicalTrials.gov Identifier: NCT00359320
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : August 2, 2006
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms Procedure: pancreaticojejunostomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy
Study Start Date : July 2006
Primary Completion Date : July 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. length of hospitalization
  2. percutaneous intervention rates
  3. reoperation rates
  4. morbidity
  5. death


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Thomas Jefferson University:
Pancreaticoduodenectomy
Pancreaticojejunostomy
Pancreatic Cancer

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