Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Trial for Extraction of Difficult 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: NCT00852072
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
AdventHealth

Brief Summary:
Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty), mechanical lithotripsy or single-operator cholangioscopy guided laser lithotripsy techniques. There are currently no randomized trials comparing laser lithotripsy and sphincteroplasty techniques for the removal of difficult bile duct stones and the aim of this randomized trial is to determine which technique is superior in the removal of difficult bile duct stones.

Condition or disease Intervention/treatment Phase
Common Bile Duct Stones Procedure: Single-operator cholangioscopy-guided laser lithotripsy Procedure: Balloon Sphincteroplasty Not Applicable

Detailed Description:

Stones in the common bile duct (CBD) can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients with small bile duct stones using standard endoscopic techniques. This comprises endoscopic sphincterotomy whereby the duodenal sphincter at the entrance of the bile duct is cut during endoscopic retrograde cholangiopancreatography (ERCP) and subsequent removal of the stone is achieved using standard accessories such as a basket and/or extraction balloon. However, large/difficult bile duct stones (at least 12mm in size), multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories. In such cases, the three most commonly practiced advanced maneuvers for extraction of difficult CBD stones are mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided laser lithotripsy (SOC-LL).

Endoscopic large balloon sphincteroplasty (using CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) is a technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 20mm (depending on size of the distal CBD) after performing an endoscopic sphincterotomy. Following dilation, the stone is removed using a basket and/or extraction balloon. This technique was shown to be effective in clearing the bile duct in 50-60% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.

The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator cholangioscopy system, which allows direct visualization of the bile duct stone. The main advantage of this technique is that the cholangioscope can be inserted into the endoscope and then guided through the bile duct to reach the stone. A probe can then be inserted into the cholangioscope to allow the energy from laser (laser lithotripsy) to be accurately focused onto the stone to cause stone fragmentation under direct visualization. The use of SpyGlass system with laser lithotripsy has been shown to be successful in the clearance of difficult bile duct stones in 73-100% patients.

Although various methods for removal of bile duct stones exist, there have been thus far no studies directly comparing endoscopic large balloon sphincteroplasty with cholangioscopy-guided laser lithotripsy for clearance of difficult bile duct stones. The aim of this study is therefore to compare the efficiency of the single-operator cholangioscopy-directed laser lithotripsy using the SpyGlass Direct Visualization system versus endoscopic large balloon sphincteroplasty for clearance of difficult bile duct stones.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones
Study Start Date : March 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Active Comparator: Single-operator cholangioscopy guided laser lithotripsy
Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
Procedure: Single-operator cholangioscopy-guided laser lithotripsy
Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy

Active Comparator: Balloon sphincteroplasty
Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy
Procedure: Balloon Sphincteroplasty
Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy




Primary Outcome Measures :
  1. Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session using either the single-operator cholangioscopy-guided laser lithotripsy-based technique or large balloon sphincteroplasty-based technique [ Time Frame: 24 months ]
    Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session


Secondary Outcome Measures :
  1. Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques [ Time Frame: 24 months ]
    Safety is defined as the incidence of adverse events

  2. Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques [ Time Frame: 24 months ]
    Costs include total costs pertaining to the treatment of bile duct stones including costs of procedure, medications, hospitalization, radiology, laboratory, anesthesia and supplies.

  3. Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques [ Time Frame: 24 months ]
    Repeat interventions is defined as the need for more than one ERCP session for complete clearance of the bile duct of stones



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or over
  • Common bile duct stones that measure at least 1.2 cm who have failed stone removal using standard techniques at ERCP

Exclusion Criteria:

  • Patients unable to provide informed consent due to any diminished capacity
  • Pregnant patients or age < 18 years or prisoners
  • Presence of bleeding disorders
  • Patients with altered post-surgical anatomy
  • Pregnancy

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): NCT00852072


Locations
Layout table for location information
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
AdventHealth
Investigators
Layout table for investigator information
Principal Investigator: Shyam Varadarajulu, MD AdventHealth
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT00852072    
Other Study ID Numbers: 718940
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A manuscript will be developed when the study is complete.
Keywords provided by AdventHealth:
common bile duct stones
mechanical lithotripsy
balloon sphincteroplasty
single-operator cholangioscopy-guided laser lithotripy
Additional relevant MeSH terms:
Layout table for MeSH terms
Calculi
Pathological Conditions, Anatomical