An interventional study of Initial therapy with papillary balloon dilation and Initial therapy with intraductal lithotripsy in Choledocholithiasis, sponsored by University of Southern California. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 115 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
107 studies on the registry are indexed under Choledocholithiasis; 23 are open to participants now.
This study's planned enrollment of 90 is below the median of 103 across 72 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Exclusion Criteria:
Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety.
Procedure: Initial therapy with intraductal lithotripsy
Balloon dilation of the Ampulla of Vater after a small sphincterotomy is an alternative technique that allows for removal of large bile duct stones in a safe and effective manner.
Procedure: Initial therapy with papillary balloon dilation
patients will first undergo papillary dilation
Also known as: papillary dilation
patients will first undergo intraductal laser or electrohydraulic lithrotripsy
First procedure stone clearance
Entire stone\[s\] removed in first procedure
Time frame: 2 hours
Adverse Events
Pancreatitis, bleeding, perforation, infection
Time frame: 1 week
Procedure Time
Length of procedure
Time frame: 2 hours
Plan to share: No
Started Sep 2018 (actual). Primary completion is estimated for Dec 2024, 75 months after the start.
Of 40 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's planned 75 months is above that.
Counting every sponsor, half of 41 studies reached it within 23 months; a quarter within 14 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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