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Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.

Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia. - Phase I study for the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003295
Enrollment
30
Registered
2010-03-06
Start date
2010-03-01
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

interstitial pneumonia, lung cancer, metastatic lung tumor, pneumothorax

Interventions

From the 2nd day before an operation, ulinastatin was administered as a 30 min infusion of 300000 U for 3 consecutive days. The dose of the ulinastatin reduced by 100000 unit every 3rd day.

Sponsors

Tokyo Women's Medical University of Medicine, Department of Surgery I
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Preoperative chest CT scans IP findings were checked by a radiologist. The criteria for identifying IPF on a chest high-resolution computed tomography (HRCT) were subpleural space shadow, honeycomb formation, reticular shadow, tractional bronchitis/bronchioles etc., and consolidation. 2.IP findings such as fine crackles at the bilateral lower lung were checked by a pulmonologist. 3.Performance status of 0 to 1 4.The functions of the main organs such as bone marrow, heart, liver, and kidney are kept. Within 2 weeks before registration, the criteria are follows. White blood cell count >=3000mm3-<=12000mm3 Neutrophil count >=1500mm3-<=5000mm3 Platelet count >=50000mm3 Hemoglobin >=8g/dL Serum KL-6 >=500U/mL Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT); 2 times upper limit of normal in our hospital 5.A case that an operation under the general anesthesia is possible. 6.A case that a document agreement by the person himself was provided about examination participation.

Exclusion criteria

Exclusion criteria: 1.Having the history of allergic reaction against ulinastatin. 2.Asbestosis. 3.Chronic hypersensitivity pneumonitis. 4.Sarcoidosis. 5.Pregnancy.

Design outcomes

Primary

MeasureTime frame
Judging whether a side effect of the ulinastatin appeared. Evaluating the kind of the side effect, frequency, grade of the ulinastatin.

Secondary

MeasureTime frame
Judging whether acute exacerbation of the postoperative interstitial pneumonia appeared.

Countries

Japan

Outcome results

None listed

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