Papillary Balloon Dilation Versus Intraductal Lithotripsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Randomized Trial of Cholangioscopy Guided Intraductal Lithotripsy Versus Papillary Balloon Dilation for the Endoscopic Treatment of Large Bile Duct Stones

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: Initial therapy with papillary balloon dilation
* Procedure: Initial therapy with intraductal lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years and older Undergoing ERCP at LAC+Medical Center or Keck Hospital of USC for the standard indication of bile duct stones with evidence of a large stone (>1cm) demonstrated either on Ultrasound, computed tomography, prior ERCP, or magnetic resonance imaging. Exclusion Criteria: Patients Under the age of 18 Patients with biliary malignancy Prior biliary diversion surgery Prior gastric bypass surgery Patients who are incarcerated Patients who are unable to give consent Patients who pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 115 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized using a pre-generated randomization schedule with concealed allocation in a 1:1 assignment to initial cholangioscopy guided lithotrispy or papillary dilation. Randomization will be blocked in groups of 12.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraductal lithotripsy<br>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<br>* patients will first undergo intraductal laser or electrohydraulic lithrotripsy<br>|
| Active Comparator: Papillary Balloon dilation<br>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<br>* patients will first undergo papillary dilation<br>* Other names: papillary dilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First procedure stone clearance | Entire stone[s] removed in first procedure | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Pancreatitis, bleeding, perforation, infection | 1 week | 
| Procedure Time | Length of procedure | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic retrograde cholangiopancreatograhy, bile duct stones, choledocholithiasis, ERCP