Randomized Trial for Extraction of Large 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00852072
Recruitment Status : Recruiting
First Posted : February 26, 2009
Last Update Posted : June 1, 2018
Information provided by (Responsible Party):
Florida Hospital

Brief Summary:
Removal of large bile duct stones can be technically challenging at ERCP. Particularly, when the size of the stone is more than 1.2cm they are removed using a metal basket (lithotripsy). This can sometimes be technically challenging and may require more than one ERCP session. Recently, a balloon has been used to enlarge the opening of the bile duct (sphincteroplasty) to help easy removal of stones in one ERCP session. There are no studies comparing the lithotripsy and sphincteroplasty techniques. This randomized trial is designed to address the question of which technique is superior for bile duct stone extraction: lithotripsy versus sphincteroplasty.

Condition or disease Intervention/treatment Phase
Common Bile Duct Stones Procedure: Mechanical Lithotripsy Procedure: Balloon Sphincteroplasty Not Applicable

Detailed Description:

Stones in the bile duct can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis.1 Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients 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.2 However, large (≥ 15mm in size) or multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories.2 In such cases, mechanical lithotripsy can be performed for stone fragmentation prior to removal. This involves the use of a basket and a sheath that can be wrapped around the stone, which are in turn attached to a handle that is turned to result in stone fragmentation.1,2 Although shown to be effective in 84-98% of patients with large stones, this method can be cumbersome and time-consuming.2

Endoscopic Balloon sphincteroplasty (EBS) [(Hurricane RX Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) or CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA)] is an alternative technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 8-20mm (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 89-95% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.3 Furthermore, in a randomized trial comparing endoscopic sphincterotomy alone versus EBS for removal of bile duct stones, the use of mechanical lithotripsy was significantly lower in the EBS group (28.8% for EBS vs. 46.2% for endoscopic sphincterotomy only, p=0.028), although the overall stone clearance rates were comparable between the two groups (89% for ESBD vs. 88.5% for ES only, p=0.279).4

The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator peroral cholangioscopy system (POC) which allows direct visualization of the bile duct stone.2 The main advantage of this technique is that a probe can be inserted into the endoscope and then guided through the bile duct to reach the stone. Using this probe, the energy from laser (laser lithotripsy) can be accurately focused onto the stone to cause stone fragmentation under direct visualization.1 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.4-9

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 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 Large Bile Duct Stones
Study Start Date : March 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Mechanical lithotripsy
Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using mechanical lithotripsy.
Procedure: Mechanical Lithotripsy
Ability to clear the CBD of all stones using mechanical lithotripsy within 20 minutes following sphincterotomy.

Active Comparator: Balloon sphincteroplasty
Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using balloon sphincteroplasty.
Procedure: Balloon Sphincteroplasty
Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using balloon sphincteroplasty.

Primary Outcome Measures :
  1. Compare technical success defined as the ability to clear the bile duct of all stones within 20 minutes in one ERCP session using either the sphincteroplasty or mechanical lithotripsy techniques. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Compare the safety of the balloon sphincteroplasty and mechanical lithotripsy techniques. [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 19 years,
  • Common bile duct stones that measure more than 1.2 cm at ERCP.

Exclusion Criteria:

  • Patients unable to provide informed consent due to any diminished capacity,
  • Pregnant patients or age < 19 years or prisoners,
  • Presence of bleeding disorders,
  • Patients with altered post-surgical anatomy.

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 identifier (NCT number): NCT00852072

Contact: Shyam Varadarajulu, MD 205-934-7989

United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Shyam Varadarajulu, MD    407-303-2750   
Contact: Robin E Barron-Nelson, RN, MSN    407.303.5503   
Sponsors and Collaborators
Florida Hospital
Principal Investigator: Shyam Varadarajulu, MD Florida Hospital

Responsible Party: Florida Hospital Identifier: NCT00852072     History of Changes
Other Study ID Numbers: 718940
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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 Florida Hospital:
common bile duct stones
mechanical lithotripsy
balloon sphincteroplasty

Additional relevant MeSH terms:
Pathological Conditions, Anatomical