Availability of endoscopic ultrasonography for the diagnosis of choledocholithiasis undetected by other modalities: multicenter non-randomized, non-blind exploratory clinical trial

Availability of endoscopic ultrasonography for the diagnosis of choledocholithiasis undetected by other modalities: multicenter non-randomized, non-blind exploratory clinical trial - EUS biliary stone study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028558

Enrollment

Registered

2017-08-07

Start date

2017-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

choledocholithiasis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age of 20 years or older (2) Suspected of having choledocholithiasis with epigastralgia/ right hypochondralgia due to unknown origin or serum elevated levels of T-bilirubin, AST, ALT, gamma-GT and ALP (3) Highly suspeted of having choledocholithiasis based on ASGE guideline (4) Performance Status (PS) Grade 0-3 (5) Being able to providing informed consent for participation

Exclusion criteria

Exclusion criteria: (1) Having a biliary stone detected by any of US, CT or MRCP (2) Severe cholangitis (Grade III) based on Tokyo guideline 2013 (3) Bile duct stricture detected by any of US, CT, MRCP (4) Having the past history of endoscopic treatment of choledocholithiasis (5) Intubated with a biliary stent (6) Ampullary tumor (7) Having tumor invation at the major papilla (8) With Billroth II or Roux-en-Y reconstruction after gastrectomy (9) Choledocho-duodenal fistula (10) Consciousness disturbance with Japan Coma Scale (JCS) I-2 or severe (11)(12) Severe cardiopulmonary disease (13) Pregnancy or during breast-feeding (14) Judged inappropriate by a research director

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of EUS for choledocholithiasis	—

Countries

Japan

Contacts

Public ContactMasaki Kuwatani

Hokkaido University Faculty of Medicine and Graduate School of Medicine Department of Gastroenterology and Hepatology

mkuwatan@med.hokudai.ac.jp011-716-1161

Outcome results