Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis
Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
1 other identifier
observational
60
1 country
1
Brief Summary
Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 15, 2013
August 1, 2013
5.2 years
March 8, 2010
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stricture resolution of the common bile duct in the two study groups
Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography
2.5 years
Secondary Outcomes (3)
Stent removability
Time from stent removal to 1 month post-stent removal
Occurrence of complications related to stents and procedure
2.5 years
Length of endoscopic procedures in the two groups
All endoscopic procedures
Study Arms (2)
Plastic stent
Covered SEMS
Eligibility Criteria
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
You may qualify if:
- Benign biliary stricture caused by chronic pancreatitis
You may not qualify if:
- Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- University of Turkucollaborator
- Oulu University Hospitalcollaborator
Study Sites (1)
Helsinki University Central Hospital
Helsinki, 00290, Finland
Related Publications (1)
Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
PMID: 25590182DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorma Halttunen, MD, PhD
Helsinki University Central Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jorma Halttunen, MD, PhD
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 12, 2010
Study Start
March 1, 2008
Primary Completion
May 1, 2013
Study Completion
May 1, 2015
Last Updated
August 15, 2013
Record last verified: 2013-08