Choledocholithiasis

14

Review clinical trials related to Choledocholithiasis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis

Choledocholithiasis (stone(s) in the common bile duct) is common. Untreated or missed, choledocholithiasis has high morbidity and mortality. Endoscopic retrograde cholangio-pancreatography (ERCP) is recognized as the first-line modality for management. While effective, ERCP is associated with adverse events. Thus, the selection of patients for ERCP should be accompanied by a high pre-test suspicion of choledocholithiasis. Choledocholithiasis is suspected based on clinical, biochemical and radiographic findings. The most relied-upon strategy for risk stratification of choledocholithiasis is based on guidelines from The American Society for Gastrointestinal Endoscopy (ASGE). In it, clinical predictors are defined as "very strong", "strong" or "moderate", and the presence of one or more of these is meant to suggest "high" or "intermediate" probability of choledocholithiasis. A knowledge gap exists in the performance characteristics of intermediate-probability criteria, where overall accuracy is \<50% from limited data. Patients in this group are recommended to a) undergo endoscopic ultrasound (EUS) or magnetic resonance cholangio-pancreatography (MRCP), b) undergo cholecystectomy with intra-operative cholangiography (IOC), or c) proceed directly to ERCP. At centres where EUS and MRCP are readily available, these are preferred options, as they are least invasive and sensitive; however, they are often unavailable. Thus, in clinical practice, a high proportion of intermediate-risk patients ultimately proceed directly to ERCP, where likelihood of benefit is only moderate, while procedural risk remains. The role of liver enzyme changes has not been evaluated; however, dynamic changes may offer another method for evaluating patients at intermediate risk of CBD stones that is safe and available. Incorporation of dynamic liver enzymes may improve the test-performance characteristics of the existing framework.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of CalgaryUpdated: Apr 29, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Patients with suspected choledocholithiasis, regardless of probability [+2]

Unable or unwilling to provide informed consent; [+6]

Status: Recruiting

Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones

The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are: Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones. Participants will: Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device. Answer a call 30 days after the procedure to document symptoms and/or any side effects.

Participants needed: 40
Trial details
Phase: Phase 4Age: 19-85Biological sex: AllType: InterventionalSponsor: Rush University Medical CenterUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Age 19-85 years [+5]

Pregnancy: Repeated ERCP would be delayed until after delivery if possible [+7]

Status: Recruiting

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?

Participants needed: 172
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: National University of MalaysiaUpdated: Feb 12, 2026Locations: 1
Eligibility criteria

The patients diagnosed with mild and moderate acute cholangitis based on TG 18 [+2]

Severe acute cholangitis [+5]

Status: Not yet recruiting

Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial

Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails. Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail. Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.

Participants needed: 840
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Asian Institute of Gastroenterology, IndiaUpdated: Jan 12, 2026
Eligibility criteria

Valid indication for ERCP (benign or malignant obstruction). [+4]

Ampullary mass or tumor preventing standard cannulation view. [+3]

Status: Recruiting

Prospective Comparison of the Carbon Footprint of EUS vs MRCP for Evaluation of Suspected Choledocholithiasis

MRCP and EUS are diagnostically equivalent in detecting CBD stones among patients with intermediate risk, as shown in a landmark RCT. However, MRI-based imaging is power-intensive, requiring large infrastructure and long scan durations. EUS, a less energy-consuming and portable procedure, has the added advantage of enabling same-session ERCP, reducing the need for repeat procedures.

Participants needed: 200
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Asian Institute of Gastroenterology, IndiaUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Age ≥18 years [+2]

High or low likelihood category (per ESGE) [+2]

Status: Recruiting

Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis

Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Participants needed: 1,000
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Asian Institute of Gastroenterology, IndiaUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Patients having co-exiting disease of pancreato biliary system other than gall s... [+3]

Status: Recruiting

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.

Participants needed: 400
Trial details
Age: 75+Biological sex: AllType: InterventionalSponsor: Helsinki University Central HospitalUpdated: Oct 7, 2025Locations: 12
Eligibility criteria

Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatog... [+2]

Acute Cholecystitis [+6]

Status: Not yet recruiting

Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) remain fundamental tools for the diagnosis and treatment of many pancreatobiliary diseases. However, there are situations in which these procedures face limitations, such as the evaluation of indeterminate ductal strictures or the management of complex choledocholithiasis. Direct visualization of the biliary and pancreatic ducts has proven to be a useful and effective alternative in such cases. It also has a safety profile comparable to conventional ERCP, with only a slight increase in the incidence of adverse events. Nevertheless, due to the associated increase in costs, most centers have adopted a stepwise approach in their diagnostic and therapeutic algorithms, using this technique only after multiple ERCPs. Although the evidence is still limited, recent studies suggest that early use of direct cholangiopancreatoscopy could be a cost-effective strategy due to its increased efficacy. In this regard, collecting data on direct cholangiopancreatoscopy would be of interest to generate robust conclusions on cost-effectiveness in routine clinical practice. This study aims to objectively assess the real-world use of direct cholangiopancreatoscopy in our setting, with the goal of confirming technical aspects, efficacy, and safety, and ultimately conducting cost-effectiveness evaluations to determine the optimal point in the algorithm at which this technique should be introduced.

Participants needed: 260
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Germans Trias i Pujol HospitalUpdated: Jul 14, 2025Duration: 1 Year
Eligibility criteria

Patients undergoing cholangiopancreatoscopy at the participating centers from 1... [+2]

Age under 18 years. [+2]

Status: Recruiting

Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones

Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC( laparoscopic cholecystectomy) after ERCP( endoscopic retrograde cholangiopancreatography). The aim of this prospective study is to evaluate the efficacy and safety Laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis.

Participants needed: 80
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Minia UniversityUpdated: Jun 19, 2025Locations: 1
Eligibility criteria

Patients having stone(s) in the gallbladder and concurrent common bile duct , as... [+3]

History of hepatobiliary surgery as choledochoduodenal anastomosis [+11]

Status: Recruiting

Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

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.

Participants needed: 150
Trial details
Age: 75+Biological sex: AllType: InterventionalSponsor: Hospital del Rio HortegaUpdated: Mar 11, 2025Locations: 1
Eligibility criteria

Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically... [+2]

Charlson comorbidity scale adjusted to age <4. [+14]

Status: Recruiting

Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)

Participants needed: 25
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Feb 28, 2025Locations: 1
Eligibility criteria

Age 20 years or more [+7]

Severe acute cholecystitis [+11]

Status: Not yet recruiting

Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography

Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications. There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement. Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP. Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.

Participants needed: 3,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Germans Trias i Pujol HospitalUpdated: Nov 1, 2024Duration: 30 Days
Eligibility criteria

Over 18 years of age [+1]

Under 18 years of age [+2]

Status: Recruiting

The Treatment Effect for Asymptomatic Common Bile Duct Stone

This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.

Participants needed: 120
Trial details
Age: 18-85Biological sex: AllType: ObservationalSponsor: Kyungpook National University HospitalUpdated: Jan 22, 2024Locations: 1
Eligibility criteria

diagnosed as common bile duct stone by image modality examination [+1]

no definite common bile duct stone by image modality examination [+6]