Randomized Trial for Extraction of Difficult Bile Duct Stones

Completed · Not applicable

Conditions studied: Common Bile Duct Stones

In brief

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.

Key facts

Study ID

NCT00852072

Run by

AdventHealth

People needed

66

Starts

2016-03-01

Expected to finish

2018-12-31

Last updated by the study team

2019-10-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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