Laser Versus Mechanical Lithotripsy of Bile Duct Stones
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01759979|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : March 31, 2017
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 or disease||Intervention/treatment||Phase|
|Choledocholithiasis||Procedure: Laser and mechanical lithotripsy Procedure: Mechanical Lithotripsy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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.
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.
- 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.
- 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.
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): NCT01759979
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California|