jRCT1030260094RecruitingNot Applicable
Utility of Cholangioscopy After Stone Removal for Common Bile Duct Stones in Patients with Surgically Altered Anatomy: A Single-Center Prospective Exploratory Study
Not provided0 sites10 target enrollmentStarted: TBD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Patients in whom common bile duct stones were identified on pre-procedural imaging (computed tomography, magnetic resonance cholangiopancreatography, ultrasonography, endoscopic ultrasonography, or balloon enteroscopy-assisted ERCP) and who were considered to require endoscopic stone removal.
- •Patients with surgically altered anatomy (excluding Billroth I reconstruction).
- •Patients with a distal bile duct diameter >=8 mm.
- •Patients with a modified American Society of Anesthesiologists physical status (mASA-PS) classification of II or lower.
- •Patients aged >=18 years who provided written informed consent to participate in the study.
Exclusion Criteria
- •Patients in whom discontinuation of antithrombotic agents was considered difficult.
- •Patients with cholangitis, severe jaundice (total bilirubin >5 mg/dL), or pancreatitis.
- •Patients in whom single-session stone removal was considered difficult, including those with stacked stones, stones >15 mm in diameter, Mirizzi syndrome, or concomitant biliary stricture.
- •Patients with a history of pancreatitis following balloon enteroscopy-assisted ERCP (BE-ERCP).
- •Patients who were pregnant or possibly pregnant.
- •Patients who were deemed unsuitable for participation in this study by the principal investigator or sub-investigators for medical or safety reasons.
Investigators
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