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Prospective evaluation of biliary neoplasms with endoscopic biopsy-based next generation sequencing

Prospective evaluation of biliary neoplasms with endoscopic biopsy-based next generation sequencing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008279
Enrollment
100
Registered
2023-03-08
Start date
2023-03-31
Completion date
Unknown
Last updated
2023-04-04

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

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age > 18 and age < 80 2. Suspected cholangiocarcinoma based on clinical work up and image modality that required cytopathological confirmation

Exclusion criteria

Exclusion criteria: 1, Patients who have malignancy other than cholangiocarcinoma 2. Decompensated cardiopulmonary diseases 3. Coagulation disorders (international normalized ratio >1.5 or platelets <50,000/mm3) 4. Subjects who are currently receiving antithrombotic therapy but cannot be discontinued or postponed 5. Pregnant 6. Patients who cannot undergo endoscopy under conscious sedation due to underlying disease 7. Patients in whom endoscopy is not possible due to surgically altered anatomies or gastric outlet obtruction 8. Subjects who failed to obtain informed consent

Design outcomes

Primary

MeasureTime frame
Diagnostic yield of mutational analysis performed on specimens obtained under endoscopic tissue acquisition

Secondary

MeasureTime frame
diagnostic accuracy;the procurement rates of histologic tissues that the pathologist considered to be of optimal quality for NGS;safety

Countries

Korea, Republic of

Contacts

Public ContactDongwook Oh

Asan Medical Center

wooki219@naver.com+82-2-3010-3189

Outcome results

None listed

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