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Accuracy of revised 2019 ASGE high-risk criteria for suspected choledocholithiasis: A prospective cohort multicenter study

Accuracy of revised 2019 ASGE high-risk criteria for suspected choledocholithiasis: A prospective cohort multicenter study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210812001
Enrollment
220
Registered
2021-08-12
Start date
2021-08-11
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

High-risk patients for choledocholithiasis Choledocholithiasis, Endoscopic retrograde cholangiopancreatography, Guideline, Endosonography

Interventions

A patient who has the criteria of ascending cholangitis directly received ERCP. Other patients underwent EUS, and if choledocholithiasis was detected by EUS then proceed to ERCP.
Experimental Device
Endoscopic diagnosis of choledocholithiasis

Sponsors

Rajavithi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The patients who have at least one of the following high-risk criteria for choledocholithiasis: 1. Common bile duct stone on the ultrasound or cross-sectional imaging 2. Total bilirubin >4 mg/dL and dilated common bile duct 3. Ascending cholangitis

Exclusion criteria

Exclusion criteria: 1. A history of liver transplantation 2. An active liver disease, including primary sclerosing cholangitis 3. A history of biliary surgery 4. Suspicion of pancreaticobiliary malignancy 5. A previously placed endobiliary stent or sphincterotomy 6. A history of biliary stricture 7. Concomitant IHD stones 8. Decompensated cirrhosis

Design outcomes

Primary

MeasureTime frame
The presence of choledocholithiasis At the end of intervention Confirmed by EUS, or ERCP

Secondary

MeasureTime frame
The impact of laboratory trends At the end of intervention The presence of choledocholithiasis confirmed by EUS, or ERCP

Countries

Thailand

Contacts

Public ContactApichet Sirinawasatien

Division of Gastroenterology, Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University

sui_apichet@hotmail.com0816862151

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026