Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The study will be a prospective single blind randomized comparative trial. All patients presenting with choledocholithiasis will be considered for the study. If their ultrasound, computed tomography, or magnetic resonance imaging demonstrates a large stone (>1cm) and they do not fulfill the exclusion criterion they will be eligible for the study. If a prior Endoscopic retrograde cholangiopancreatography (ERCP) demonstrates a stone >1cm, which could not be removed with standard methods, they will also be eligible. Randomization will be stratified based on whether or not the procedure is a first or repeat ERCP Patients will be randomized using a computer generated randomization schedule with concealed allocation in a 1:1 assignment (allocation ratio) to initial cholangioscopy guided lithoripsy versus initial papillary dilation. Randomization will be blocked in groups of 12. In those randomized to cholangioscopy-guided lithotripsy, the procedure will be performed in the standard manner using a single operator cholangioscopy system and a holmium laser or EHL (dependent on availability). Those in the papillary dilation arm will undergo the standard approach using the combined papillary dilation balloon sphincterotomy system. The patients will be blinded as to treatment arm. "Conventional" methods including mechanical lithotripsy or stent placement may be used to remove stones/debris in combination with the specified intervention, as is done for standard clinical care. Use of these strategies will be recorded If stone removal fails with the assigned strategy, this will be considered failure of the assigned intervention. This decision will be made by the attending endoscopist and recorded. The patient will then crossover into the other treatment arm. The primary outcome will be complete stone clearance in the first study procedure by the assigned method. Additional outcomes will be total procedure time, cost of equipment, and number and type of complications. Additional ERCP may be needed for complete removal in some cases (i.e. complete removal in first attempt is not possible), thus we will also compare the number of ERCP needed for final stone clearance and whether stone removal is eventually achieved by endoscopic methods (comparison will be on an intention to treat basis). Additionally, if patients require surgical stone removal for the standard clinical indication in the case that endoscopic strategies are not successful, this will be recorded. The patients will be followed clinically by the principal investigator assisted by a research coordinator on days 1,7 and 30 post procedures. This will be done as a brief follow up visit if the patient is still hospitalized or by telephone call thereafter. Thus, all procedures performed in this study represent standard clinical care, which would be used even if the patients did not take part in the study, except that the initial choice to use cholangioscopy guided lithotripsy versus papillary dilation will be randomized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03536247
Study type Interventional
Source University of Southern California
Contact Jessica Serna
Phone 323-409-6939
Email Jessica.Serna@med.usc.edu
Status Recruiting
Phase N/A
Start date September 7, 2018
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05035433 - Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP N/A
Not yet recruiting NCT06060002 - Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis N/A
Recruiting NCT06041113 - Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones
Completed NCT02461147 - Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Recruiting NCT00416234 - Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis N/A
Active, not recruiting NCT05592795 - Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Recruiting NCT05056506 - EPLBD With Limited EST vs. EPLBD for Choledocholithiasis N/A
Completed NCT02515474 - Comparison of LCBDE vs ERCP + LC for Choledocholithiasis N/A
Recruiting NCT05429203 - Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope N/A
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Completed NCT02647593 - The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
Not yet recruiting NCT06066372 - Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis
Completed NCT04716166 - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery N/A
Completed NCT03074201 - Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP N/A
Withdrawn NCT01475864 - Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance N/A
Recruiting NCT06265311 - IDUS in CBD Stone Recurrence High Risk Patients N/A
Completed NCT02870686 - EUS Guided ERCP in Bile Duct Stone Removal N/A
Recruiting NCT05611840 - RCT on Robotic vs. Endo-laparoscopic Approach for Difficult Choledocholithiasis N/A
Recruiting NCT03102281 - Microbiomes in Patients of Recurrent Common Bile Duct Stones N/A
Active, not recruiting NCT00329888 - Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering N/A