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Cholestasis clinical trials

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NCT ID: NCT04391153 Recruiting - Biliary Stricture Clinical Trials

FISH in Diagnosis of Biliary Stricture

Start date: May 3, 2020
Phase: N/A
Study type: Interventional

The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities- modalities we have today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study aims to proove the feasibility and to evaluate the impact of Fluorescent In Situ Hybridization (FISH) on the tissue diagnostic of biliary strictures.

NCT ID: NCT04309773 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

BEZASCLER
Start date: April 6, 2021
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic acid therapy

NCT ID: NCT04281082 Recruiting - Clinical trials for Cholestasis of Pregnancy

Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives

Start date: January 1, 2018
Phase:
Study type: Observational

To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.

NCT ID: NCT04170933 Recruiting - Clinical trials for Biliary Tract Diseases

Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.

NCT ID: NCT04167358 Recruiting - Cholestasis Clinical Trials

Linerixibat Long-term Safety, and Tolerability Study

LLSAT
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

NCT ID: NCT04071197 Recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus. Their treatment poses a great challenge, with medical treatment is not successful in many cases. Moreover, the available non-transplant surgeries carry many side effects and different degrees of efficacy. Partial external biliary diversion, internal biliary diversion, and ileal exclusion still lack widespread experience with many side effects. Nasobiliary stent placement has little tolerability, especially in younger age. Gastrobiliary tube is a novel modality for external biliary diversion in such patients.

NCT ID: NCT04010734 Recruiting - Biliary Stricture Clinical Trials

Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures

Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study´s aim is to compare the diagnostic yield of primary peroral cholangioscopy and ERCP (with conventional sampling - brushing and forceps biopsy - completed with the FISH) in patients with suspected malignant stricture of the common bile duct and to evaluate the impact of both methods on the management of patients with biliary stricture.

NCT ID: NCT03921502 Recruiting - Choledocholithiasis Clinical Trials

Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

PECAS
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence. The investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications. The study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.

NCT ID: NCT03842150 Recruiting - Biliary Atresia Clinical Trials

Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study

Start date: June 1, 2014
Phase:
Study type: Observational

Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.

NCT ID: NCT03834285 Recruiting - Cirrhosis, Liver Clinical Trials

Liver Disease in Pregnancy

Start date: May 9, 2019
Phase:
Study type: Observational

Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts. Moreover, the population prevalence of these diseases is low and to-date, it has proven difficult to generate reliable data at a patient level. This is a multi-center, prospective cohort study that will open at 3 centers within the UK; and 4 centers in the European Union. The investigators will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy. The main rationale behind this study is to establish a platform that enables detailed review of the outcomes of these rare diseases; to help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.