Primary sclerosing cholangitis. Cholangitis
Conditions
Interventions
Intervention group: Patients with primary sclerosing cholangitis are selected according to inclusion and exclusion criteria. In the first step, using an endosonography device, one million cells per ki
Sponsors
Vice-Presidency for Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age: 18-70y Diagnosis of PSC during the visit (ALP/?GT values > 6 times the normal limit) Radiological AND /OR histological evidence of clinically documented PSC Complete the informed consent form
Exclusion criteria
Exclusion criteria: Alternative diagnosis for sclerosing cholangitis (eg, secondary sclerosing cholangitis, IgG4-dependent sclerosing cholangitis) The presence of acute or chronic kidney damage caused by another disease other than PSC Presence of evidence of port thrombosis in initial ultrasound or during endosonography Being on the liver transplant list Active participation in anther clinical trial Active alcohol consumption Blood levels of AST, ALT, ALKP > 10 times the normal limit, platelet 3 times the normal limit, INR > 1.3, hemoglobin less than 10 Evidence or diagnosis of severe concomitant disease (such as severe cardiovascular disease, HIV infection, ascites due to cirrhosis, etc.) Any history or evidence of viral hepatitis Diagnosis or suspicion of hepatocellular carcinoma or cholangiocarcinoma Known sensitivity to the products used in the trial Acute relapse of the disease in the 90 days leading up to entering the trial that requires treatment intensification Current treatment using biological drugs Presence of billiary percutaneous drainage Any history of malignancy Endoscopic evidence of portal hypertension and/or portal thrombosis Pregnancy or breast feeding Receiving any vaccine within 6 weeks of the first visit Evidence or history of cholangitis in the past 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No side effects and safety. Timepoint: Before initiating the study, 1, 8, 9 and 24 weeks after the intervention. Method of measurement: Doctor's assessment by examining and checking vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Alkaline phosphatase changes. Timepoint: Before the intervention and weeks 1, 8, 9 and 24 after the intervention. Method of measurement: Alkp laboratory kit.;Liver enzyme (AST,ALT) changes. Timepoint: Before the intervention and weeks 1, 8, 9 and 24 after the intervention. Method of measurement: laboratory kit.;Bili rubin level changes. Timepoint: Before the intervention and weeks 1, 8, 9 and 24 after the intervention. Method of measurement: laboratory kit.;Changes in gamma glutamil transferase level. Timepoint: Before the intervention and weeks 1, 8, 9 and 24 after the intervention. Method of measurement: laboratory kit.;Coagulation factors changes. Timepoint: Before the intervention and weeks 1, 8, 9 and 24 after the intervention. Method of measurement: laboratory kit.;Quality of life improvement. Timepoint: Before the intervention, 24 weeks after the intervention. Method of measurement: Chronic Liver Disease Questionnaire.;Changes in bile duct fibrosis. Timepoint: Before the intervention, 24 weeks after the intervention. Method of measurement: MRCP.;Liver parenchyma fibrosis changes. Timepoint: Before the intervention, 24 weeks after the intervention. Method of measurement: Elastography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Beheshti-Maal
Shahid Beheshti University of Medical Sciences
Outcome results
None listed