- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929538
Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis
Covered Self-expandable Metal Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
Study Overview
Status
Conditions
Detailed Description
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis with or without acute pancreatitis are prospectively enrolled in the study. The age and gender of the patients and the aetiology of the pancreatitis will be recorded.
At initial presentation, clinical and laboratory findings recorded include liver function tests, abdominal pain, jaundice and cholangitis. Pancreatic calcifications are documented in abdominal computed tomography. Patients with malignancies, cirrhosis, acute/chronic hepatitis or abnormal hepatic imaging studies are excluded. Patients with first attack of acute pancreatitis will be excluded.
The approval of the ethics committee of the hospital has been obtained. An informed consent will be obtained from all patients.
All patients are prepared and sedated for ERCP as per standard medical practice of the hospital. At the initial ERCP, an endoscopic sphincterotomy will be performed and the presence/absence of bile duct stones above the stricture and the treatment of stones are recorded. A pancreatic stent will be inserted if indicated. For the initial ERCP the patients will be randomized into two groups: those who receive 10 mm diameter cSEMS and those who receive 12 mm diameter cSEMS into the bile duct. For the randomization, sealed envelopes will be used. The length of the cSEMS is recorded.
Further ERCP for stent removal will be performed after six months for the patients with 12 mm diameter cSEMS and after twelve months for the patients with 10 mm diameter cSEMS. In case of stent migration during the follow-up, the stent will be replaced by a similar new cSEMS. If a pancreatic stent will be placed, the removal or replacement will be handled according to the hospital practice.
After each ERCP procedure, all patients will stay in hospital for monitoring the occurrence of primary complications such as acute pancreatitis and cholangitis, bile leak, bleeding or perforation. Plasma amylase activity is measured same day > 4h after ERCP. Post-ERCP pancreatitis is defined as the presence of abdominal pain attributable to acute pancreatitis and plasma amylase level at least three times above the upper limit of the reference interval. The treatment of primary complications is recorded.
Follow-up
Clinical response (adequate biliary drainage) and recurrent stricture formation are the primary endpoints of the study. Therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ERCPs at the time of the initial ERCP and at removal of cSEMS. Blood liver function tests are measured in the morning before ERCPs; the exact widths and lengths in mm:s are obtained by comparison the widths and lengths with the diameter of the scope. In addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal.
Morbidity and mortality are additional endpoints of the study. Therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. Patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00029
- Helsinki University Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Benign biliary stricture caused by chronic pancreatitis
Exclusion Criteria:
- Malignancy, cirrhosis, acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Covered biliary metal stent, 12 mm
ERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter
|
endoscopic retrograde cholangiopancreatography
|
Active Comparator: covered Biliary metal stent, 10 mm
ERCP and placement of a covered self-expanding biliary metal stent, 10 mm in diameter
|
endoscopic retrograde cholangiopancreatography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stricture resolution of the common bile duct in the two study groups
Time Frame: 2,5 years
|
Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography
|
2,5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent removability
Time Frame: 1 year
|
Ability to remove stents endoscopically after six months and one year without stent-removal related complications
|
1 year
|
Occurrence of complications related to stents and procedure
Time Frame: 2,5 years
|
2,5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biliary stricture Chronic pancreatitis
Time Frame: 2,5 years
|
2,5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leena Kylänpää, MD, PhD, Helsinki University Central Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 175/13/03/02/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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