Randomized Trial for Extraction of Difficult Bile Duct Stones

NCT00852072 | Completed

• 1 other identifier: 718940
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Bile Duct Stones

Keywords

common bile duct stones; mechanical lithotripsy; balloon sphincteroplasty; single-operator cholangioscopy-guided laser lithotripy

Outcome Measures

Primary Outcomes (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

  Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session

  24 months

Secondary Outcomes (3)

• Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques

  24 months

• Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques

  24 months

• Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques

  24 months

Study Arms (2)

Single-operator cholangioscopy guided laser lithotripsy

ACTIVE COMPARATOR

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

Balloon sphincteroplasty

ACTIVE COMPARATOR

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

Interventions

Single-operator cholangioscopy-guided laser lithotripsy PROCEDURE

Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy

Single-operator cholangioscopy guided laser lithotripsy

Balloon Sphincteroplasty PROCEDURE

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

Balloon sphincteroplasty

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (1)

• 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.

  PMID: 32057976 DERIVED

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: March 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)