Multicenter study on the clinical usefulness of a new method diagnosing earlier development of pancreatic fibrosis, which targets proteolytic TGF-B-activation reaction.

Multicenter study on the clinical usefulness of a new method diagnosing earlier development of pancreatic fibrosis, which targets proteolytic TGF-B-activation reaction. - Multicenter study on diagnostic usefulness of TGF-B LAP-D for early stage of chronic pancreatitis.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007271

Enrollment

100

Registered

2012-02-13

Start date

2012-02-01

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

Chronic pancreatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients matching definite chronic pancreatitis, probable chronic pancreatitis, early chronic pancreatitis, possible chronic pancreatitis or possible early chronic pancreatitis according to the Japanese clinical diagnostic criteria 2009. 2. Patients with Performance Status 0-1. 3. Patients without major organ insufficiency. 4. Patients with written and oral informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with infections, difficult to control, for examples active tuberculosis. 2. Patients with severe drug allergy. 3. Patients with difficulty in the performance of endoscopy. 4. Patients with malignancy. 5. Patients with history of anticancer drug. 6. Patients with possible causes developing hepatic fibrosis without alcohol consumption, such as, viral hepatitis, autoimmune hepatitis,non-alcoholic steatohepatitis, and CBD stones etc. 7. Patients with two times or more of the level of normal alanine transaminase (ALT). 8. Patients with interstitial pneumoniae and lung fibrosis. 9. Patients with severe complications. 10. Patients with pregnancy, lactating, possibility of pregnancy, or will of pregnancy. 11. Patients with severe mental disorder.

Design outcomes

Primary

Measure	Time frame
To study whether the level of TGF-B LAP-D correlates with the stage of chronic pancreatitis.	—

Countries

Japan

Outcome results