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A NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE, SINGLE ARM CLINICAL STUDY OF THE
X-SUIT NIR® COVERED BILIARY METALLIC STENT FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE VIA ENDOSCOPIC APPROACH

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.The objective of…

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…

The diagnostic performance of different diagnostic tests to detect post-ERCP pancreatitis: trypsinogen-2 urinary dipstick test and serum trypsinogen-2, amylase, lipase and a prediction model

Primary objective: - To evaluate the diagnostic performance of the urinary trypsinogen-2 test for post-ERCP pancreatitisSecondary objectives: - To evaluate the diagnostic performance of serum trypsinogen-2, serum amylase/lipase for post-ERCP…

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.

Sensitivity of cholangioscopy directed biopsies versus brush cytology in patients with malignant bileduct stenosis

Aim of this study is to assess the value of cholangioscopic directed biopsies versus brush cytology in differentiating between malignant and benign biliary strictures. Determination of tumor markers to improve early diagnosis of malignant biliary…

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

Burden of ERCP;
Preferences for treatment of common bile duct stones

The aim of this study is: 1) to determine the burden of ERCP in patients undergoing ERCP (descriptive study) and 2) to determine patients preferences for treatment strategy of CBDS (Discrete Choice Experiments).

Intraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study

The primary objective is to confirm the diagnosis of biliary atresia by visualisation of the (remaining) biliary tract using fluorescence cholangiography.

The use of covered expandable stents with a proximal lasso to resolve benign post-surgical biliary strictures

To investigate feasibility, safety, and effectiveness of covered expandable stents with a proximal lasso to resolve benign post-surgical strictures.

PROSPECTIVE STUDY OF THE PROGNOSTIC VALUE OF TRANSIENT ELASTOMETRY (FIBROSCAN) IN PRIMARY SCLEROSING CHOLANGITIS (PSC) PATIENTS (FICUS STUDY)

To determine the prognostic value of transient elastography (Fibroscan) in PSC patients.

EUS-guided choledochoduodenostomy (versus ERCP) for primary drainage of malignant distal biliary obstruction: a pilot study

To establish the effectiveness and safety of EUS-CD as the primary drainage strategy in patients with malignant distal biliary obstruction.

Preoperative functional liver assesement with primovist enhanced MRI for patients with suspected resectable perihilar cholangiocarcinoma: a proof-of-concept pilot study

To assess whether MRI Primovist could replace 99mTc-mebrofenin HBS as a preoperative functional liver assessment in addition to CT-volumetry in predicting PHLF in patients with resectable pCCA who require a major liver resection.

Needle-knife fistulotomy (NKF) for primary biliary access in patients with choledocholithiasis; a *real world* prospective multicenter pilot study

To explore the safety and efficacy of NKF as the primary cannulation technique in patients with an indication for sphincterotomy in tertiary as well as teaching centers after standardized training on an ex-vivo ERCP model.

Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial)

To evaluate the efficacy of SBRT as additional treatment after standard care chemotherapy regarding tumor local control, toxicity, progression-free survival, overall survival and quality of life. In addition, to explore the value of immunodynamics…

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.

Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

To proof feasibility and safety of direct SEMS placement for palliative treatment of perihilar cholangiocarcinoma.

Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study

To analyse complications due to primary percutaneous stenting in patients with resectable pCCA.

Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a pilot-study

To assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.

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.