Choledocholithiasis
Conditions
Interventions
Follow-up without ERCP treatment.
Follow-up with ERCP treatment.
Sponsors
Keio University School of Medicine
National Hospital Organization Tokyo Medical Center Yokohama Municipal Citizen'
s Hospital Saiseikai Central Hospital Tokyo Dental College Ichikawa General Hospital Saitama Medical Center Saitama City Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with common bile duct stones by imaging diagnosis of CT scan, MRI (including MRCP) scan, or EUS scan 2) Patients who meet the criteria for asymptomatic 3) Patients with a stone diameter of 4 mm or less (any test modality or number of stones, rounded to the nearest whole number) 4) Patients with naive vater papilla (no history of ERCP) 5) Patients aged 20 years or older, regardless of gender 6) Patients who are expected to survive for at least 5 years 7) Patients who have given their written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients who do not agree to participate in this study 2) Patients who cannot undergo endoscopic treatment due to their general condition, jaw, oral, or gastrointestinal condition 3) Patients who are in poor general condition or have serious complications with American Society of Anesthesiologists (ASA) class 4 or higher 4) Patients with conditions after upper gastrointestinal reconstruction other than Billroth-I reconstruction 5) Patients after duodenal papillectomy, papilloplasty, or surgical bile duct gastrointestinal anastomosis 6) patients with primary sclerosing cholangitis (PSC), IgG4-related cholangitis, or primary biliary cholangitis (PBC) 7) Patients with a history of allergy to biliary contrast agent or severe allergy to angiographic contrast agent 8) Patients who, if assigned to group B, will not be able to undergo ERCP within 1 month 9) Patients who are pregnant or may become pregnant 10) Patients for whom follow-up observation is considered impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of biliary complications Incidence rate of ERCP complications Overall biliary complication-free survival rate Hospitalization days | — |
Countries
Japan
Contacts
Public ContactAtsuto Kayashima
Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed