Randomized Trial for Extraction of Difficult Bile Duct Stones

A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Stones
• Intervention / Treatment: Procedure: Single-operator cholangioscopy-guided laser lithotripsy; Procedure: Balloon Sphincteroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques	Safety is defined as the incidence of adverse events	24 months
Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques	Costs include total costs pertaining to the treatment of bile duct stones including costs of procedure, medications, hospitalization, radiology, laboratory, anesthesia and supplies.	24 months
Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques	Repeat interventions is defined as the need for more than one ERCP session for complete clearance of the bile duct of stones	24 months

Collaborators and Investigators

• Sponsor: AdventHealth

Publications and helpful links

General Publications

• Bang JY, Sutton B, Navaneethan U, Hawes R, Varadarajulu S. Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2349-2356.e3. doi: 10.1016/j.cgh.2020.02.003. Epub 2020 Feb 10.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 25, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: common bile duct stones; mechanical lithotripsy; balloon sphincteroplasty; single-operator cholangioscopy-guided laser lithotripy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Calculi
• Other Study ID Numbers: 718940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A manuscript will be developed when the study is complete.