Papillary Balloon Dilation Versus Intraductal Lithotripsy

NCT ID: NCT03536247

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Choledocholithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraductal lithotripsy

Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety.

Group Type: ACTIVE_COMPARATOR

Initial therapy with intraductal lithotripsy

Intervention Type: PROCEDURE

patients will first undergo intraductal laser or electrohydraulic lithrotripsy

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.

Group Type: ACTIVE_COMPARATOR

Initial therapy with papillary balloon dilation

Intervention Type: PROCEDURE

patients will first undergo papillary dilation

Interventions

Initial therapy with papillary balloon dilation

patients will first undergo papillary dilation

Intervention Type: PROCEDURE

Initial therapy with intraductal lithotripsy

patients will first undergo intraductal laser or electrohydraulic lithrotripsy

Intervention Type: PROCEDURE

Other Intervention Names

papillary dilation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 115 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Ara Sahakian

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ara Sahakian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

James Buxbaum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Keck Hospital of USC

Los Angeles, California, United States

Site Status: RECRUITING

Los Angeles County + USC Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Serna

Role: CONTACT

Jessica.Serna@med.usc.edu

323-409-6939

James Buxbaum, MD

Role: CONTACT

James.Buxbaum@med.usc.edu

323-409-6939

Facility Contacts

Jeannette Delgado

Role: primary

323-442-8462

James Buxbaum, MD

Role: primary

323-409-1000 ext. 6939

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Other Identifiers

HS-17-00448

Identifier Type: -

Identifier Source: org_study_id