A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy - Full Text View

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

This study is currently recruiting participants.
Verified by Thomas Jefferson University, May 2008

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00359320

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

MedlinePlus related topics:

Cancer Fistulas Intestinal Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study ID Numbers:	06U.198
First Received:	August 1, 2006
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00359320
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Pancreaticoduodenectomy

Pancreaticojejunostomy

Pancreatic Cancer

Study placed in the following topic categories:

Biliary Tract Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Neoplasms

Endocrine System Diseases

Intestinal Diseases

Intestinal Neoplasms

Duodenal Neoplasms

Digestive System Diseases

Biliary Tract Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Pancreatitis

Duodenal Diseases

Endocrine Gland Neoplasms

Pancreatitis, Chronic

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008