common bile duct stone common bile duct stone
Conditions
Interventions
None listed
Sponsors
Ishii Tomohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Primary Registration (Prior to ERCP) 1) Patients diagnosed with or suspected of having common bile duct stones based on imaging studies (abdominal ultrasound, CT, MRI, endoscopic ultrasound [EUS], or ERCP [IDUS may be combined]) performed at our hospital, along with laboratory findings and clinical symptoms, and who are scheduled for stone extraction and cholangioscopy via ERCP. 2)Must be 18 years of age or older at the time of study registration. 3) Cases where cholangioscopy is anticipated to be feasible following endoscopic stone removal. 4)The participant has received sufficient explanation of the study content and has provided written informed consent. [2] Secondary Registration (After ERCP) 1) Bile duct cannulation was feasible. 2) The bile duct opening was visible, and cholangioscopy insertion was feasible. 3) There was no uncontrollable bleeding or perforation during EST, EPBD, or EPLBD, and cholangioscopy insertion was feasible.
Exclusion criteria
Exclusion criteria: [1] Primary registration (prior to ERCP) 1) Cases with postoperative reconstructive bowel other than Billroth-I reconstruction. 2) Cases with bleeding tendencies. 3) Cases with severe cholangitis according to the Tokyo Guideline 2018. (However, cases are not excluded after improvement of severe cholangitis.) 4) Cases of Gallstone pancreatitis. (However, cases are not excluded after improvement of pancreatitis.) 5) Cases involving pregnancy or potential pregnancy. 6) Other cases deemed unsuitable for inclusion based on the physician's judgment. [2] Secondary Registration (After ERCP) 1) Cases where sedation during the procedure was difficult or where the duodenoscope could not be inserted. 2)Cases where bile duct cannulation was not possible. 3) Cases where visualization of the papilla was not possible, making cholangioscope insertion impossible. 4) Cases where bile duct opening was insufficient or bile duct diameter was too narrow, making cholangioscope insertion difficult. 5)Cases with no stones detected during ERCP. 6) Cases where residual stones were clearly visible during cholangiography, requiring additional stone removal at a later date (e.g., too many stones to remove in one session, or a large stone was fragmented but not completely removed in one session). Secondary registration at a later date is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate (%) of residual stones by cholangioscopy and 95% confidence interval (CI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events (pancreatitis, cholangitis, bleeding, perforation.) and analysis of risk factors. Detection rate of biliary desease during cholangioscopy (findings such as biliary tract cancer, hyperplasia, strictures.). Risk factor analysis for cases with residual stones. | — |
Contacts
Public ContactTomohiro Ishii
Saiseikai Yokohamashi Nanbu Hospital
Outcome results
None listed