Efficacy of transpapillary biopsies for multi- gene panel testing of biliary tract cancer: Prospective observational study.

Efficacy of transpapillary biopsies for multi- gene panel testing of biliary tract cancer: Prospective observational study. - Efficacy of transpapillary biopsies for multi- gene panel testing of biliary tract cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049826

Enrollment

Registered

2022-12-19

Start date

2022-12-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients need to examination and treatment by ERCP for suspected biliary tract cancer 2. Possible to get written informed consent from patients 3. Ages 20 and older

Exclusion criteria

Exclusion criteria: 1. Patients with performance status 3 or 4 2. Patients with severe complications to other organs 3. Patients with severe coagulation dysfunction 4. Patients judged inappropriate by chief medical examiner

Design outcomes

Primary

Measure	Time frame
Appropriate sampling rate 1.Tumor ratio: 20% or more 2.DNA concentration: 1.0 ng/mL or more 3.DIN (DNA Integrity Number) value: 2 or more	—

Secondary

Measure	Time frame
1. Tumor ratio 2. Section surface area 3. DNA concentration 4. Estimated Nucleic Acid Abundance 5. DIN value 6. Procedural success rate 7. Adverse event 8. Success rate of multi-gene panel testing	—

Countries

Japan

Contacts

Public ContactKazuya Miyamoto

Okayama University Hospital Department of Gastroenterology

ttpcx442@yahoo.co.jp086-235-7219

Outcome results