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Prospective study evaluating the efficacy of a super-thin choledochoscope in the laparoscopic transcystic common bile duct exploration

Prospective study evaluating the efficacy of a super-thin choledochoscope in the laparoscopic transcystic common bile duct exploration - Efficacy of a super-thin choledochoscope in laparoscopic common bile duct exploration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027169
Enrollment
30
Registered
2017-05-01
Start date
2017-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who are diagnosed, or suspected, as harboring common bile duct (CBD) stones and scheduled to undergo elective laparoscopic cholecystectomy

Interventions

Laparoscopic transcystic common bile duct exploration using a super-thin choledochoscope

Sponsors

Aichi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients diagnosed with CBD stones, confirmed or suspected as a result of clinical symptoms, serological tests, ultrasonography or MRCP, who are scheduled to undergo elective laparoscopic cholecystectomy (regardless of whether they underwent endoscopic sphincterotomy) 2 Patients older than 19 years of age at the time of surgery 3 Patients providing written informed consent

Exclusion criteria

Exclusion criteria: 1 Large(9mm or more) or multiple (n=6 or more)CBD stones 2 Suspected primary CBD stones 3 Intrahepatic stones or biliary dilatation 4 Aberrant hepatic duct which joins the cystic duct or the bile duct close to the cystic duct 5 Anomalous arrangement of the pancreaticobiliary ducts 6 Suspected biliary malignancy 7 Allergic to radiopaque contrasts 8 Short cystic duct making the introduction of choledochoscope problematic 9 Acute cholecystitis 10 Presence of a biliary stent at the time of surgery

Design outcomes

Primary

MeasureTime frame
The primary outcomes are successful insertion of the super-thin choledochoscope into the common bile duct (CBD) via transcystic route and successful CBD exploration of both the distal (to the papilla) and proximal (to the bifurcation) parts of the bile duct.

Secondary

MeasureTime frame
To evaluate whether the choledochoscope contributes to improvement in the detection and one-stage clearance of CBD stones

Countries

Japan

Contacts

Public ContactShunichiro Komatsu

Aichi Medical University Gastroenterological Surgery

skomat@aichi-med-u.ac.jp0561-62-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026