Common Bile Duct Stone
Conditions
Brief summary
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.
Detailed description
Endoscopic sphincterotomy is a standard technique to enlarge the bile duct opening before stone removal during endoscopic retrograde cholangiopancreatography. However, complete sphincter ablation by endoscopic sphincterotomy is not always possible. Also, due to the tapering end of the distal duct, standard sphincterotomy may not be adequate for removal of particularly large stones. In a retrospective series by Ersoz et al, the addition of balloon dilation after sphincterotomy achieves a high stone clearance rate (89-95%). The investigators postulate that the combination of endoscopic sphincterotomy followed by balloon dilation may allow easier stone retrieval with acceptable complication rate.
Interventions
PROCEDUREendoscopic balloon dilatation
Refer to description under arms
PROCEDUREStandard sphincterotomy
Refer to under arms
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stone clearance rate at the index session | 24 hours | The ability to achieve complete stone clearance on the first ERCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ERCP's required to achieve stone clearance | 3 months | The number of ERCP procedures required to achieve complete stone clearance in the bile duct |
| ERCP related complications | 30 days | These include complications that were described in consensus published in 1991 |
Countries
China
Outcome results
None listed