Common bile duct stone Common bile duct stone, Choledocholithiasis
Conditions
Interventions
Currently, endoscopic sphincterotomy (EST) is the first-line treatment for papillary intervention in the management of small common bile duct stones. This study aims to evaluate the efficacy of minima
D016717
minimal endoscopic sphincterotomy with balloon dilation, ESBD, endoscopic sphincterotomy, EST
Sponsors
Inoue Tadahisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with common bile duct stones via imaging modalities such as CT, MRCP, abdominal ultrasound, or endoscopic ultrasound. 2. Patients for whom endoscopic stone removal is deemed necessary. 3. Patients who are 18 years of age or older at the time of consent, regardless of gender. 4. Patietns who have received a thorough explanation of the study, fully understood it, and provided written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with common bile duct stones measuring 12 mm or more in diameter. 2. Patients with surgically altered anatomy other than Billroth-I reconstruction. 3. Patients with biliary tract reconstruction. 4. Patients with concomitant biliary strictures. 5. Patients with biliary tumors, including duodenal papillary tumors. 6. Patients with intradiverticular papilla. 7. Patients taking antithrombotic agents where withdrawal or adjustment of medication is not feasible in accordance with the guidelines. 8. Patients with bleeding tendency (platelet count 1.5). 9. Patients with concomitant severe cholangitis. 10. Patients with concomitant pancreatitis. 11. Patients with any prior intervention at the duodenal papilla. 12. Patients in which endoscopic treatment is deemed unsafe. 13. Patients who are pregnant or possibly pregnant. 14. Patients deemed unsuitable for this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of procedure-related adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Type and severity of procedure-related adverse events 2. Technical success rate (rate at which ESBD or EST was completed as per protocol) 3. Clinical success rate (rate of complete stone removal in a single session) 4. Total procedure time (from the start of biliary cannulation to completion of stone removal) 5. Procedure time required for stone removal (from completion of ESBD or EST to completion of stone removal) 6. Rate of mechanical lithotripsy performed 7. Stone recurrence rate during the follow-up period (up to 5 years after registration), following successful stone removal 8. Time to stone recurrence during the follow-up period (up to 5 years after registration), following successful stone removal 9. Incidence of biliary events during the follow-up period (up to 5 years after registration), following successful stone removal 10. Time to biliary event occurrence during the follow-up period (up to 5 years after registration), following successful stone removal | — |
Contacts
Public ContactTadahisa Inoue
Aichi Medical University
Outcome results
None listed