Primary Sclerosing Cholangitis Clinical Trial
Official title:
Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract of unknown origin. Around 50% of patients develop during their disease course narrowing of the main bile duct with corresponding increase in symptoms such as itching, jaundice and abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion of a plastic endoprosthesis. However, it is not known which of these two therapeutic modalities is best. This study aims to compare both techniques in order to determine which is best in terms of postponing recurrence of the narrowing, safety and costs.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - PSC ascertained with MRCP, ERCP, PTC and/or liver biopsy or - PSC highly suspected and to be confirmed with present ERCP - Age between 18-75 years - Total bilirubin > 3x ULN or rsie in alkaline phosphatase or bilirubin > 50% together with increase in cholestatic complaints Exclusion Criteria: - Prior stenting or balloon-dilatation within last 6 months - Clinical signs serious suppurative cholangitis reflected by either fever > 39.0 °C, tachycardia, leukocytosis and elevated CRP, or fever > 38,5 C together with purulent bile found during ERCP. - Change of ursodeoxycholic acid therapy shorter than two months ago. - Inability to give written informed consent - Signs of biliary cirrhosis Child-Pugh B or C - Estimated transplant-free survival shorter than 2 years as calculated by a Mayo score < 2 - Serious suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of metastasis, MRCP with mass lesion with contrast enhancement, rise in CA19.9 of > 63 U/ml with an absolute value > 130 U/ml 14 . - Signs of current malignancy other than basocellular skin carcinoma. - Inability to give informed consent. - Life expectancy < 24 months. - Use of antibiotics in previous 4 weeks. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | UZLeuven | Leuven | |
Netherlands | Academic Medical Center | Amsterdam | |
Norway | Rikshospitalet | Oslo | |
Sweden | Karolinska Institute | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Belgium, Netherlands, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recurrence-free interval of the primary dominant stricture | 24 months | No | |
Secondary | number of patients with adverse events in both groups | adverse events within first 3 months after the intervention | 3 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02239211 -
A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Withdrawn |
NCT03216876 -
A Study Of Ursolic Acid For Primary Sclerosing Cholangitis
|
Phase 1 | |
Recruiting |
NCT02605213 -
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
|
Phase 4 | |
Recruiting |
NCT01688024 -
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Completed |
NCT03041662 -
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
|
||
Completed |
NCT05866809 -
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Recruiting |
NCT05618145 -
National Database on Primary Sclerosing Cholangitis (PSC)
|
||
Active, not recruiting |
NCT02446665 -
Disease Status in Primary Sclerosing Cholangitis by Elastography
|
N/A | |
Completed |
NCT02247934 -
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
|
N/A | |
Completed |
NCT01088607 -
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
|
Phase 1 | |
Terminated |
NCT01142323 -
Pilot Study of Fenofibrate for PSC
|
Phase 1/Phase 2 | |
Terminated |
NCT04060147 -
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
|
Phase 1 | |
Recruiting |
NCT04133792 -
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
|
Phase 3 | |
Active, not recruiting |
NCT04595825 -
CM-101 in PSC Patients -The SPRING Study
|
Phase 2 | |
Recruiting |
NCT03183570 -
Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
|
Early Phase 1 | |
Completed |
NCT02943460 -
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
|
Phase 2 | |
Completed |
NCT00951327 -
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)
|
N/A | |
Completed |
NCT04024813 -
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
|
Phase 2 | |
Recruiting |
NCT05912387 -
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
|
Early Phase 1 | |
Completed |
NCT02884557 -
NKT Role in the Regulation of the Inflammatory Bowel Disease
|
N/A |