Randomized Trial Comparing Spincteroplasty and Lithotripsy for Extraction of Large Bile Duct Stones

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00852072
First received: February 25, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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 Intervention
Common Bile Duct Stones
Procedure: Mechanical Lithotripsy
Procedure: Balloon Sphincteroplasty
Procedure: Balloon sphincteroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Spincteroplasty and Lithotripsy for Extraction of Large Bile Duct Stones

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 technuiques. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the safety of the baloon shincteroplasty and mechanical lithotripsy techniques. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: February 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Balloon sphincteroplasty
Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using balloon sphincteroplasty.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852072

Locations
India
Insititute for Digestive Diseases and Advanced Endoscopy
Mumbai, Maharashtra, India
Sponsors and Collaborators
Shyam Varadarajulu
  More Information

No publications provided

Responsible Party: Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00852072     History of Changes
Other Study ID Numbers: F090121002
Study First Received: February 25, 2009
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
common bile duct stones
mechanical lithotripsy
balloon sphincteroplasty

Additional relevant MeSH terms:
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014