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A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)

Primary Objective: • Evaluate the treatment effect of NGM282 as measured by the mean change in alkaline phosphatase (ALP) from Baseline to Week 12 in patients with PSC.Secondary Objectives:• Assess the safety and tolerability of NGM282 in patients…

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial
Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl
Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC)

The primary objective of this study is:• To evaluate whether simtuzumab (formally referred to as GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.The secondary objectives of this study include the following…

Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO)

To compare the outcome of early laparoscopic cholecystectomy (<72 hrs after randomization) with interval laparoscopic cholecystectomy (25-30 days after randomization) after mild biliary pancreatitis.

PLASTIC STENTS VERSUS HEPARIN COATED PLASTIC STENTS FOR RELIEF OF MALIGNANT BILE-DUCT OBSTRUCTION

in this project we will compare conventional 10fg plastic endoprosthesis with similar stents covalently coated with heparin

Bile suppletion as adjuvant therapy in the treatment of iatrogenic bile duct injury after cholecystectomy: a bitter necessity?

The primary study objective is to investigate the contribution of peri-operative suppletion of bile to the preservation of bodyweight (expressed in kilograms).Secondary study objectives:1.To determine the contribution of peri-operative suppletion of…

The effect of tamsulosin on the spontaneous passage of bile stones

Primary objective: 1. Determine difference in stone expulsion rate with -and without Tamsulosin Secondary objectives: 1. Time to stone expulsion2. Stone expulsion rate in patients with cholangitis with -and without Tamsulosin3. Adverse events 4.…

ERCP brush cytology of pancreatobiliary strictures - Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial

To compare the sensitivity of ERCP brush cytology between standard RX cytology brush and Inifinity brush in patients with pancreatobiliary strictures suspicious for malignancy.

Prospective, Multi-center, Randomized Controlled Study Comparing
Endoscopic Clearance of Non-Complex Biliary Stones Using
Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to
Standard of Care Endoscopic Retrograde Cholangiography (ERC)

The aim of this study is to prospectively assess the benefits and effectiveness of non-complex gallstone clearancefluoroscopy / radiation-free direct solitary cholangioscopy (DSC) comparing the SpyGlass * system to non-complex biliary stone…

Primary percutaneous stenting above the ampulla versus endoscopic drainage
for unresectable malignant hilar biliary obstruction.

To compare the efficacy of PPS above the ampulla to standard EBD in patients with MHBO who are ineligible for surgical resection.

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)

This study has been transitioned to CTIS with ID 2024-512086-14-00 check the CTIS register for the current data. Primary Objective:The primary objective is to evaluate the efficacy of repeated once-daily doses of odevixibat versus placebo in…

Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid

To evaluate the efficacy of two doses of norucholic acid vs. placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA).

Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after
adequate endoscopic BiliaRy drAinage (COBRA trial).

The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.