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Choledocholithiasis clinical trials

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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: NCT03754491 Completed - Clinical trials for Cholangitis; Choledocholithiasis

The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis

ERCP
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.

NCT ID: NCT03709030 Completed - Clinical trials for Cholecystitis; Acute, Choledocholithiasis

Early MRI in Acute GallstonE Disease

E-MAGED
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This pilot study aims to determine the utility of direct Magnetic Resonance Cholangiopancreatography (MRCP) in the assessment of suspected acute gallstone disease presentations. This will take the form of a randomized controlled trial, the design of which is based on recent internal audit data which indicated that a high proportion of patients ultimately require MRCP prior to diagnosis, treatment and discharge, and suggested that early scan may improve overall costs and outcomes. Patients with symptoms and signs suggestive of suspected gallstone disease and deranged liver function tests/amylase (i.e. suggestive of a potentially obstructive gallstone disease), will be enrolled across the full range of 'front-door' locations for surgical presentations within the hospital (Emergency Department, Surgical Emergency Unit, Ambulatory Assessment Unit), and randomized to one of two diagnostic pathways which are both existing variations in current clinical care: 1. MRCP is used as the first mode of imaging; 2. following a standard care model (ultrasound then MRCP if deemed appropriate). An assessment will then be undertaken of the cost-effectiveness of early MRCP versus standard care, using the primary outcome measure of cost to diagnostic scan report calculated using hospital episode statistics (HES), with secondary outcome measures to assess the overall utility which include length of stay, time to diagnosis, overall cost of admission using HES, in-hospital complications, Patient Reported Outcome Measures (PROMs), readmission and re-attendance rates (ED/GP), and service/radiology costs.

NCT ID: NCT03658863 Recruiting - Choledocholithiasis Clinical Trials

"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated. Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.

NCT ID: NCT03536247 Recruiting - Choledocholithiasis Clinical Trials

Papillary Balloon Dilation Versus Intraductal Lithotripsy

Start date: September 7, 2018
Phase: N/A
Study type: Interventional

Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy initially employing cholangioscopy guided intraductal lithotripsy (laser/electrohydraulic lithtripsy (EHL)) versus a strategy initially using papillary dilation for removal of large bile duct stones.

NCT ID: NCT03250286 Completed - Choledocholithiasis Clinical Trials

Role of EUS in High Risk of Choledocholithiasis

Start date: July 25, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate that patients with high risk of choledocholithiasis who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group] have less negative outcomes (including false-negative results and procedure-related complications) than patients who undergo ERCP in all patients with high risk of choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes (including false-negative results and procedure-related complications) in both groups. The secondary outcomes included days of hospitalization and the rate of diagnostic ERC.

NCT ID: NCT03102281 Recruiting - Cholelithiasis Clinical Trials

Microbiomes in Patients of Recurrent Common Bile Duct Stones

Start date: May 1, 2017
Phase: N/A
Study type: Observational

Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.

NCT ID: NCT03074201 Completed - Choledocholithiasis Clinical Trials

Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.

NCT ID: NCT02958059 Recruiting - Klatskin Tumor Clinical Trials

Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality. Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected. In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.

NCT ID: NCT02870686 Completed - Choledocholithiasis Clinical Trials

EUS Guided ERCP in Bile Duct Stone Removal

Start date: May 2013
Phase: N/A
Study type: Interventional

For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is highy accurate technique in detecting common bile duct stone and guiding for therapeutic intervention. There has been a few data from literature showed that EUS guided CBD stone ( CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and complications. This randomized trial is designed to address the question that EUS guided CBDS removal is equivalent to ERCP in term of efficacy and safety.