Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer

Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer - Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021109

Enrollment

120

Registered

2016-02-19

Start date

2013-10-21

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

idiopathic interstitial pneumonia (IIP)

Interventions

Control (n=30): intra- and postoperative management without Sivelestat Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Untreated patients with non-small-cell lung cancer who have plan of sergical treatment (2) Patients with IIP which shows ground-glass opacity or reticular pattern in both lungs on preoperative HR-CT

Exclusion criteria

Exclusion criteria: (1) With serious liver disorder (2) With serious renal dysfunction (3) With bleeding tentency (4) Patients registered in clinical trial of other drugs

Design outcomes

Primary

Measure	Time frame
acute exacerbation of IIP within 30 postoperative days	—

Secondary

Measure	Time frame
30 postoperative day survival rate	—

Countries

Japan

Contacts

Public ContactSumiko Maeda

Dokkyo medical university Department of general thoracic surgery

sumaeda@dokkyomed.ac.jp0282-87-2160

Outcome results

None listed

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