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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
Sponsor:
Information provided by (Responsible Party):
Ara Sahakian, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Procedure: Initial therapy with papillary balloon dilation Procedure: Initial therapy with intraductal lithotripsy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: Participants in the study will be blinded to treatment arm. Care providers and Investigators will be unblinded to treated arm.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. First procedure stone clearance [ Time Frame: 2 hours ]
    Entire stone[s] removed in first procedure


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 week ]
    Pancreatitis, bleeding, perforation, infection

  2. Procedure Time [ Time Frame: 2 hours ]
    Length of procedure



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Ages Eligible for Study:   18 Years to 115 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jessica Serna 323-409-6939 Jessica.Serna@med.usc.edu
Contact: James Buxbaum, MD 323-409-6939 James.Buxbaum@med.usc.edu

Locations
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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      
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Ara Sahakian, MD University of Southern California
Principal Investigator: James Buxbaum, MD University of Southern California
Publications:

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Responsible Party: Ara Sahakian, Assistant Professor of Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT03536247    
Other Study ID Numbers: HS-17-00448
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ara Sahakian, University of Southern California:
bile duct stones
choledocholithiasis
ERCP
endoscopic retrograde cholangiopancreatograhy
Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis