Laser Versus Mechanical Lithotripsy of Bile Duct Stones

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
ClinicalTrials.gov Identifier:
NCT01759979
First received: December 31, 2012
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

Very large bile duct stones are difficult to remove. The prefered method involves an endoscopic procedure known as endoscopic retrograde cholangiopancreatography (ERCP)performed using a special side viewing endoscope. In the past small baskets passed through the scope into the bile duct have been used to remove most stones using mechanical force.

Recently very small scopes known as cholangioscope have been introduced through the side viewing endoscope directly into the bile duct. These cholangioscopes may be used to guide laser therapy of bile duct stones. The investigators suspect that stone destruction using cholangioscopy guided laser stone destruction may enable bile duct stones to be removed more quickly and safely when added to the mechanical techniques.


Condition Intervention
Choledocholithiasis
Procedure: Laser and mechanical lithotripsy
Procedure: Mechanical Lithotripsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Trial of Combination of Cholangioscopic Guided Laser Lithotripsy and Conventional Mechanical Versus Conventional Mechanical Methods for the Endoscopic Removal of Large Bile Duct Stones

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Bile Duct Stone Clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Confirmation that no further stones remain in the bile duct of the patient by cholangiography. Additionally, serum laboratory abnormalities in AST, ALT, Alkaline Phophatase, or bilirubin, or epigastric abdominal pain attributable to bile duct stones.


Secondary Outcome Measures:
  • Number of ERCP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of ERCP procedures required from enrollment in study to complete clearance of bile duct stones.

  • Total Procedure Time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The total time in minutes for all the ERCP procedures required for stone rumoval.

  • Estimated Procedure Cost [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The cost of patient management for bile duct stones based on the cost of the procedure, hospitalization, and associated costs of complications of cholangitis, pancreatitis, perforation, and bleeding.

  • Cholangitis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cholangitis after or between ERCP procedures will be defined as a presentation with epigastric abdominal pain, temperature greater than 38.5 Celsius accompanied by either laboratory abnormalities of the AST, ALT, Alkaline Phosphatase, or Bilirubin or abnormal imaging of the biliary tree on ultrasound,computed tomography scan, or magnetic resonance cholangiopancreatography.

  • Pancreatitis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Pancreatitis following or between ERCP procedures will be defined as the onset of epigastric abdominal pain and either amylase or lipase greater than 3 times the upper limit of normal or findings on ultrasound, computed tomography scan, or magnetic resonance cholangiopancreatography suggestive of pancreatic inflammation.

  • Bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Bleeding attributable to stone therapy will be defined as a drop in hemoglobin by more than 1 gm/dl following or between ERCP procedures with no other cause identified on standard clinical evaluation.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser and mechanical lithotripsy
Bile duct stones with be treated with cholangioscopy guided laser therapy in addition to mechanical basket and balloon techniques.
Procedure: Laser and mechanical lithotripsy
Patients will undergo cholangioscopy guided laser treatment in addition to treatment with mechanical lithotripsy using basket and balloon techniques.
Other Names:
  • Spyglass cholangioscopy
  • Holmium laser lithotripsy
Active Comparator: Mechanical lithotripsy
Patients in the mechanical lithotripsy arm will undergo treatment only with basket and balloon for removal of large stones.
Procedure: Mechanical Lithotripsy
Patients in the mechanical lithotripsy arm will undergo treatment only with basket and balloons to facilitate stone removal but not laser lithotripsy.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bile duct stone >1cm demonstrated on ultrasound, computed tomography, or magnetic resonance imaging
  • Bile duct dilatation >1cm

Exclusion Criteria:

  • Biliary, gallbladder or pancreatic malignancy
  • Pregnant
  • Prior biliary diversion surgery
  • Under age 18
  • Unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759979

Contacts
Contact: Maria Trujillo 323 409 0939 mit@usc.edu
Contact: James Buxbaum, MD 323 409 5371 jbuxbaum@usc.edu

Locations
United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: James Buxbaum, MD    323-409-5371    jbuxbaum@usc.edu   
Contact: Maria Trujillo    323 409 6939    mit@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: James L Buxbaum, MD University of Southern California
  More Information

Publications:
Responsible Party: James Buxbaum, Director of Endoscopy, Los Angeles County Hospital, University of Southern California
ClinicalTrials.gov Identifier: NCT01759979     History of Changes
Other Study ID Numbers: HS-11-00718
Study First Received: December 31, 2012
Last Updated: June 29, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Southern California:
Cholelithiasis, Common Bile Duct
Choledocholithiasis

Additional relevant MeSH terms:
Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis

ClinicalTrials.gov processed this record on August 21, 2014