Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins after oral administration of 5-aminolevulinic acid.

Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins after oral administration of 5-aminolevulinic acid. - Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018896

Enrollment

100

Registered

2015-09-10

Start date

2015-09-10

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

Patients who have abnormality in the bile on CT and/or MRI.

Interventions

Oral administration of 5-aminolevulinic acid (1g/body) 3 hours before the collection of bile via ENBD tube.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients 20 years of age and older who have an abnormality in the bile on CT and/or MRI and undergo endoscopic naso-billiary drainage. 2. Patients who provide a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with porphyria. 2. Patients with hypersensitivity to 5-aminolevulinic acid or porphyries. 3. Pregnant women, women who is breast-feeding, and women suspected of being pregnant. 4. Patients who doctors regards as inappropriate ones for the enrollment due to some reasons.

Design outcomes

Primary

Measure	Time frame
The bile levels of porphyrin after oral administration of 5-aminolevulinic acid in pancreaticobiliary lesions.	—

Countries

Japan

Contacts

Public ContactTsukasa Ikeura

Kansai Medical University The Third Department of Internal Medicine

ikeurat@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026