Clinical Trial: Laser Versus Mechanical Lithotripsy of Bile Duct Stones

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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

STUDY ARMS: Laser guided lithotripsy and conventional methods vs conventional methods alone alone

BACKGROUND AND HYPOTHESES: Large bile duct stones are challenging to remove at time of endoscopic retrograde cholangiopancreatography (ERCP) and classically have required the utilization of mechanical baskets and balloons. These maneuvers may be associated with bile duct trauma, bleeding, pancreatitis, and the requirement for additional procedures. Many patients require multiple sessions using conventional mechanical approaches. A recent prospective audit of patients undergoing ERCP during the past year at LAC+USC Medical Center indicates that of approximately 500 procedures more than 250 were for bile duct stones and 100 (40%) required multiple procedures and stent placement. Scheduling challenges and limited resources make it difficult for many of these patients to return for stent changes and increases the risk of complications including cholangitis.

Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety. Direct visualization by cholangioscopy minimizes the risk of laser related bile duct injury and is potentially much less traumatic and more efficacious than traditional mechanical approaches.

A recent 15 center prospective clinical cohort study demonstrated a high success rate, 89%, and low rate of complications, 7.5%, for the single user cholangioscopy system. In a group of patients who underwent stone remov
Sponsor: University of Southern California

Current Primary Outcome: Bile Duct Stone Clearance [ Time Frame: 12 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of ERCP [ Time Frame: 12 months ]
    The number of ERCP procedures required from enrollment in study to complete clearance of bile duct stones.
  • Total Procedure Time [ Time Frame: 12 months ]
    The total time in minutes for all the ERCP procedures required for stone rumoval.
  • Estimated Procedure Cost [ Time Frame: 12 months ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: December 31, 2012
Date Started: January 2013
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017