Common Bile Duct Stone Clinical Trial
Official title:
Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones—a Randomized Controlled Trial
To compare the technique of combined balloon sphincter dilation after an initial sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct stones. The investigators hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.
Status | Completed |
Enrollment | 180 |
Est. completion date | |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients at least 18 years old, presented to Prince of Wales Hospital for endoscopic retrograde cholangiopancreatography (ERCP) for known or suspected bile duct stones are invited to participate. - Informed consent will be obtained before the beginning of ERCP. - Patients are randomized to EST or ESBD after confirming the presence of bile duct stones on the initial cholangiogram Exclusion Criteria: - septic shock, coagulopathy (international normalized ratio >1.3, - partial thromboplastin time greater than twice that of control), - platelet count <50,000x103/uL or - ampullary tumors |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Center, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | stone clearance rate at the index session | The ability to achieve complete stone clearance on the first ERCP | 24 hours | Yes |
Secondary | Number of ERCP's required to achieve stone clearance | The number of ERCP procedures required to achieve complete stone clearance in the bile duct | 3 months | No |
Secondary | ERCP related complications | These include complications that were described in consensus published in 1991 | 30 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02916199 -
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
|
N/A | |
Completed |
NCT01734720 -
Common Bile Duct Stones - Natural History and Interventions
|
N/A | |
Recruiting |
NCT05892458 -
Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy
|
N/A | |
Recruiting |
NCT03442205 -
Treatment of Common Bile Duct Stones
|
N/A | |
Completed |
NCT02460523 -
Management of Borderline Common Bile Duct Stone
|
N/A |