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Diagnostic test of multiple endoscopy combined diagnosis of unexplained biliary pancreatic duct lesions

Diagnostic test of multiple endoscopy combined diagnosis of unexplained biliary pancreatic duct lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070410
Enrollment
Unknown
Registered
2023-04-11
Start date
2023-04-14
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Unexplained biliary pancreatic duct lesion

Interventions

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-100 years; 2. Suspected biliary pancreatic duct lesions; 3. Patients who plan to undergo endoscopic retrograde cholangiopancreatography and choledochoscopy and are willing to undergo confocal microendoscopy; 4. Willing to follow the research procedures; 5. Be willing to sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients contraindicated by ERCP surgery; 2. Patients with known allergic diseases, renal failure or asthma as contraindications for fluorescein injection; 3. Allergic to fluorescein dye; 4. Pregnant or lactating patients; 5. Patients deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
ERCP combined with biliary subscope and pCLE in the diagnosis of unexplained biliary pancreatic duct lesions compared the accuracy of histological and pathological results;

Secondary

MeasureTime frame
Area under curve, AUC;Sensitivity, SEN;Specificity, SPE;Positive predictive value, PPV;Negative predictive value, NPV;Incidence rate of adverse events and serious adverse events;

Countries

China

Contacts

Public ContactShang Dong

The First Affiliated Hospital of Dalian Medical University

shangdongdalian@163.com+86 180 9887 5933

Outcome results

None listed

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