Study Stopped
Terminated by IRB
A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy
2 other identifiers
interventional
54
1 country
1
Brief Summary
The purpose of this trial is to determine whether a mucosa-to-mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Typical duration for not_applicable
1 active site
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
May 25, 2006
CompletedFirst Submitted
Initial submission to the registry
August 1, 2006
CompletedFirst Posted
Study publicly available on registry
August 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2008
CompletedMay 2, 2025
May 1, 2025
2.1 years
August 1, 2006
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the pancreatic fistula rate.
1 year
Secondary Outcomes (5)
Length of hospitalization
1 year
Percutaneous intervention rates
1 year
Reoperation rates
1 year
Morbidity
1 year
Death
1 year
Study Arms (1)
Mucosa-to-jejunal mucosa technique of pancreaticojejunosto
EXPERIMENTALDetermine whether a duct mucosa-to-jejunal mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
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. doi: 10.1016/j.jamcollsurg.2008.12.031.
PMID: 19476827DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam C Berger, MD
Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2006
First Posted
August 2, 2006
Study Start
May 25, 2006
Primary Completion
July 12, 2008
Study Completion
July 12, 2008
Last Updated
May 2, 2025
Record last verified: 2025-05