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

This study is currently recruiting participants.

Verified by Thomas Jefferson University, October 2009

First Received: August 1, 2006 Last Updated: October 19, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fistulas Intestinal Cancer Pancreatic Cancer Surgery

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 National Clinical Trials Identifier (NCT ID):

Berger AC, Howard TJ, Kennedy EP, Sauter PK, Bower-Cherry M, Dutkevitch S, Hyslop T, Schmidt CM, Rosato EL, Lavu H, Nakeeb A, Pitt HA, Lillemoe KD, Yeo CJ. Does type of pancreaticojejunostomy after pancreaticoduodenectomy decrease rate of pancreatic fistula? A randomized, prospective, dual-institution trial. J Am Coll Surg. 2009 May;208(5):738-47; discussion 747-9.

Study ID Numbers:	06U.198
Study First Received:	August 1, 2006
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00359320 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Pancreaticoduodenectomy
Pancreaticojejunostomy
Pancreatic Cancer

Additional relevant MeSH terms:

Biliary Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Duodenal Neoplasms
Neoplasms

Neoplasms by Site
Digestive System Diseases
Biliary Tract Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Duodenal Diseases
Pancreatitis
Endocrine Gland Neoplasms
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on November 27, 2009