Papillary Balloon Dilation Versus Intraductal Lithotripsy
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|ClinicalTrials.gov Identifier: NCT03536247|
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Choledocholithiasis||Procedure: Initial therapy with papillary balloon dilation Procedure: Initial therapy with intraductal lithotripsy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 Description:||Participants in the study will be blinded to treatment arm. Care providers and Investigators will be unblinded to treated arm.|
|Official Title:||Prospective Randomized Trial of Cholangioscopy Guided Intraductal Lithotripsy Versus Papillary Balloon Dilation for the Endoscopic Treatment of Large Bile Duct Stones|
|Actual Study Start Date :||September 7, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Intraductal lithotripsy
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
patients will first undergo intraductal laser or electrohydraulic lithrotripsy
Active Comparator: Papillary Balloon dilation
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
Other Name: papillary dilation
- First procedure stone clearance [ Time Frame: 2 hours ]Entire stone[s] removed in first procedure
- Adverse Events [ Time Frame: 1 week ]Pancreatitis, bleeding, perforation, infection
- Procedure Time [ Time Frame: 2 hours ]Length of procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536247
|Contact: Jessica Serna||323-409-6939||Jessica.Serna@med.usc.edu|
|Contact: James Buxbaum, MD||323-409-6939||James.Buxbaum@med.usc.edu|
|United States, California|
|Keck Hospital of USC||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Jeannette Delgado 323-442-8462|
|Los Angeles County + USC Medical Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: James Buxbaum, MD 323-409-1000 ext 6939|
|Principal Investigator:||Ara Sahakian, MD||University of Southern California|
|Principal Investigator:||James Buxbaum, MD||University of Southern California|