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Cholangitis clinical trials

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NCT ID: NCT04181138 Recruiting - Liver Diseases Clinical Trials

Primary Sclerosing Cholangitis in Children

Start date: December 30, 2021
Phase:
Study type: Observational

Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: - Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly. - Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning - Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.

NCT ID: NCT04173286 Recruiting - Acute Cholangitis Clinical Trials

Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?

CASCAD
Start date: October 7, 2019
Phase:
Study type: Observational

Acute cholangitis (AC) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. AC is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. AC can be classified into different stages of severity depending on organ failure. A severity classification has been proposed by the Asian recommendations of Tokyo 2013: Grade I (Benin), Grade II (Moderate) and Grade III (Severe). AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. It is currently recommended that patients with severe CA (Grade III) have biliary drainage within 24 hours, although it has not been shown to improve their survival. The emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of CA. A 14-day treatment is recommended in case of associated bacteremia. A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. However, this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity. The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known. The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit (ICU).

NCT ID: NCT04133792 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

PiSCATIN
Start date: October 1, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices. Subjects will be randomized (1:1) between Simvastatin and placebo.

NCT ID: NCT04076527 Recruiting - Clinical trials for Primary Biliary Cholangitis

Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis

PBC-Cohort
Start date: September 19, 2019
Phase:
Study type: Observational

The German PBC Cohort is a multi-centric, observational (non-interventional) study with three parallel groups. The main objective of this observational study is to describe the course of Primary biliary cholangitis (PBC) in patients in Germany under routine treatment with approved drugs. Therefore, the effectiveness and safety/tolerability of PBC treatment options in a real-life setting will be evaluated.

NCT ID: NCT04037007 Recruiting - Pancreatic Cancer Clinical Trials

Efficacy of Fistulotomy for Biliary Cannulation

Start date: July 3, 2019
Phase: N/A
Study type: Interventional

Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (> 200 ERCPs[Endoscopic Retrograde cholangiopancreatography]) and low experienced endoscopists (< 200 ERCPs).

NCT ID: NCT03872921 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

norUrsodeoxycholic Acid vs Placebo in PSC

Start date: February 8, 2018
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

NCT ID: NCT03743272 Recruiting - Cirrhosis Clinical Trials

Repeatability and Reproducibility of Multiparametric MRI

Start date: June 3, 2017
Phase:
Study type: Observational

This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) protocol across different field strengths, scanner manufacturers and models.

NCT ID: NCT03716232 Recruiting - Biliary Stricture Clinical Trials

Kaffes Stent in the Management of Post-surgical Biliary Strictures

Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures. Metallic stents have the theoretical benefit of absence of need of multiple sessions. These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem. The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration. This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.

NCT ID: NCT03710122 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Vancomycin for Primary Sclerosing Cholangitis

Start date: January 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD

NCT ID: NCT03703076 Recruiting - Clinical trials for Primary Biliary Cholangitis

A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life

OCARELIFE
Start date: April 10, 2018
Phase:
Study type: Observational

Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.