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Cholangitis clinical trials

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NCT ID: NCT05181332 Recruiting - Cirrhosis Clinical Trials

Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis

Start date: January 1, 2021
Phase:
Study type: Observational

The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.

NCT ID: NCT05151809 Recruiting - Clinical trials for Primary Biliary Cholangitis

National Database on Primary Biliary Cholangitis

PBC322
Start date: September 19, 2019
Phase:
Study type: Observational [Patient Registry]

Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.

NCT ID: NCT05061680 Recruiting - Bleeding Clinical Trials

Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)

SHODBADI
Start date: April 5, 2021
Phase: N/A
Study type: Interventional

ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla. The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.

NCT ID: NCT05050136 Recruiting - Clinical trials for Primary Biliary Cholangitis

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

VANTAGE
Start date: September 22, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

NCT ID: NCT04997967 Recruiting - Clinical trials for Conscious Sedation Failure During Procedure

Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.

NCT ID: NCT04950764 Recruiting - Hepatic Impairment Clinical Trials

An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Start date: September 17, 2021
Phase: Phase 1
Study type: Interventional

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

NCT ID: NCT04933292 Recruiting - Clinical trials for Primary Biliary Cirrhosis

A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome

Start date: June 16, 2021
Phase: Phase 4
Study type: Interventional

Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.

NCT ID: NCT04801238 Recruiting - Pancreatitis Clinical Trials

preGallstep - A Clinical Pilot Trial

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

NCT ID: NCT04753996 Recruiting - Cholangiocarcinoma Clinical Trials

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

Start date: March 8, 2021
Phase:
Study type: Observational

The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.

NCT ID: NCT04685200 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach

Start date: March 31, 2023
Phase:
Study type: Observational

Background: Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease. Objective: To understand the biological causes of primary sclerosing cholangitis. Eligibility: Adults age 18 and older who have primary sclerosing cholangitis. Design: Participants will be screened with a medical history, physical exam, and blood tests. Participants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys. Participants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein. Participants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum. Participants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract. Participants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken. Participants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV. Participants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow. Participants will have a liver ultrasound. Participants will complete a 3-day food diary. They will have a nutrition assessment. Participants may give contact details for people who live with them, to also take part in this study. Participation will last for 12 months....