Multicenter prospective observational study of asymptomatic choledocholithiasis
- Conditions
- Choledocholithiasis
- Registration Number
- JPRN-UMIN000051362
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival rate and its comparison by stone size
- Secondary Outcome Measures
Name Time Method 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