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Diagnostic value of Cholangioscopic biopsy combined with brush cytology for malignant biliary stricture: a multicenter randomized case-control study

Diagnostic value of Cholangioscopic biopsy combined with brush cytology for malignant biliary stricture: a multicenter randomized case-control study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070869
Enrollment
Unknown
Registered
2023-04-25
Start date
2023-05-08
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

malignant biliary stricture

Interventions

Cholangioscopy biopsy and brush group:Cholangioscopy and brush
Cholangioscopy biopsy :Cholangioscopy biopsy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-90; 2. High suspicion of malignant biliary stricture by history, laboratory tests, imaging or ultrasound endoscopy; 3. Undergo ERCP and cholangioscopic biopsy; 4. Those who have given informed consent to the project and signed the consent form.

Exclusion criteria

Exclusion criteria: 1. Failure of cannulation; 2. Benign biliary strictures from other causes, such as autoimmune cholangitis and chronic pancreatitis; 3. Coagulation dysfunction; 4. Pregnant; 5. Contraindications for ERCP; 6. Tumours of other organs not related to biliary stricture; 7. Failure of vital organs (heart, lungs, kidneys) in whom the risk of surgical intervention is considered to be extremely high; 8. Rejection of enrolment and poor adherence to follow-up; 9. Ampullary cancer; 10. Lack of abnormal mucosal changes under the cholangioscopy; 11. Failure of cholangioscopy.

Design outcomes

Primary

MeasureTime frame
Sensitivity;

Secondary

MeasureTime frame
Spectivity;Accuracy;technique success rate;Sensitivity of the visual impression of malignancy by the cholangioscope;Specificity of the visual impression of malignancy by the cholangioscope;

Countries

China

Contacts

Public ContactXiaobo Cai

Shanghai General Hospital

caixiaobo19790719@126.com+86 139 1817 7123

Outcome results

None listed

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