Skip to content

A Multicenter, Prospective Observational Study to Evaluate the Efficacy of Transoral Choledochoscopy in Screening for Early Biliary Tract Tumors in Patients with Cholelithiasis

A Multicenter, Prospective Observational Study to Evaluate the Efficacy of Transoral Choledochoscopy in Screening for Early Biliary Tract Tumors in Patients with Cholelithiasis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086740
Enrollment
Unknown
Registered
2024-07-09
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Early biliary tract tumor

Interventions

Index test:"eyeMAX"-Screening value of choledochoscopy for early biliary tract tumors

Sponsors

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient participated voluntarily and signed the informed consent; 2. Imaging diagnosis of bile duct stones; 3 Age 40-80 years old 4 Common bile duct diameter =9mm; 5 At least two of the following risk factors are met: (1) recurrent choledocholithiasis; (2) Sclerosing cholangitis; (3) Inflammatory bowel disease; (4) cholecystectomy History; (5) gallstones; (6) Liver cirrhosis; (7) Viral hepatitis (b Liver, hepatitis C); (8) Family history of biliary tract tumors; (9) Smoking and drinking history; (10) History of type 2 diabetes mellitus; (11) History of hypertension; (12) BMI > 25; (13) Patients with positive willingness to undergo choledochoscopy screening; 6.The patient himself or his family can read, understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Unstable vital signs and poor cardiopulmonary function can not tolerate endoscopy This; 2 Pregnant or lactating women; 3 Less than 3 months after participating in or completing other clinical studies; 4 Other researchers did not consider it suitable for admission.

Design outcomes

Primary

MeasureTime frame
To determine the detection rate of neoplastic bile duct lesions in patients with choledocholithiasis by transoral choledochoscopy;To determine the detection rate of ERCP in choledocholithiasis;Accuracy ;Sensitivity ;Specificity ;

Secondary

MeasureTime frame
Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactLin Rong

Department of Gastroenterology, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

selinalin35@hotmail.com+86 156 2918 0035

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026