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Clinical Trials/jRCT1030260094
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

Sponsor
Not provided

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