Prospective evaluation of biliary neoplasms with endoscopic biopsy-based next generation sequencing
Not Applicable
- Conditions
- Neoplasms
- Registration Number
- KCT0008279
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield of mutational analysis performed on specimens obtained under endoscopic tissue acquisition
- Secondary Outcome Measures
Name Time Method diagnostic accuracy;the procurement rates of histologic tissues that the pathologist considered to be of optimal quality for NGS;safety