Choledocholithiasis
Conditions
Interventions
None listed
Sponsors
Keio University
Tokyo Medical Center Yokohama Municipal 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 choledocholithiasis by CT, MRI (including MRCP), or EUS imaging 2) Patients who meet the criteria of asymptomatic (not meeting T-Bil is 2 mg/dL or greater or AST, ALT, gammaGTP, ALP is greater than 1.5*STD, and no subjective symptoms) 3) Patients with naive papillae (no history of papillotomy or plasty) 4) Patients aged 20 years or older at the time of informed consent, regardless of gender 5) Patients expected to live longer than 5 years 6) Patients who have given verbal or written consent to participate in the research
Exclusion criteria
Exclusion criteria: 1) Patients who did not consent to participate in this study 2) Patients who cannot undergo endoscopic treatment due to general condition, jaw/oral cavity/digestive tract condition 3) American Society of Anesthesiologists Preoperative Status Classification (ASA Classification) class 4 (life-threatening severe systemic disease) or worse general condition or serious complications (severe congestive heart failure, severe coronary insufficiency , myocardial infarction within 3 months, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, etc.) 4) Post-upper gastrointestinal tract reconstruction other than Billroth-I reconstruction (specifically, patients post-Billroth-II and Roux-en-Y reconstruction are excluded) 5) Patients after duodenal papillary resection, papillary papilloplasty, or surgical cholangiodigestive anastomosis 6) Patients with primary sclerosing cholangitis (PSC), IgG4-related cholangitis, or primary biliary cholangitis (PBC) 7) Patients who are pregnant or may be pregnant 8) Patients who are considered impossible to follow up at research participating facilities or related facilities or facilities with which close contact can be made
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival rate and its comparison by stone size | — |
Secondary
| Measure | Time frame |
|---|---|
| Biliary Complication Rate ERCP complication rate Overall biliary complication free survival rate Number of days in hospital Spontaneous passage rate of common bile duct stones into the duodenum ERCP success rate Recurrence rate of common bile duct stones | — |
Countries
Japan
Contacts
Public ContactAtsuto Kayashima
Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed