Efficacy and safety of Picibanil (OK-432) for pleurodesis in refractory pneumothorax and postoperative lung fistula

Efficacy and safety of Picibanil (OK-432) for pleurodesis in refractory pneumothorax and postoperative lung fistula - Picibanil for pleurodesis in refractory pneumothorax and postoperative lung fistula

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031104

Enrollment

150

Registered

2018-02-01

Start date

2018-02-01

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

Refractory pneumothorax and postoperative lung fistula

Interventions

Intrapleural injection of Picibanil once a day. A total of 1-20 KE of Picibanil can be injected within a period of 14 days if there is residual lung fistula.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patient with refractory pneumothorax or postoperative lung fistula 2) patient with intrathoracic drain 3) hospitalized patient 4) patient with written consent

Exclusion criteria

Exclusion criteria: 1) patient with past history of allergy to Picibanil or penicillin-based antibiotic 2) patient that were judged unsuitable by the treating doctor

Design outcomes

Primary

Measure	Time frame
Ratio of lung fistula that cured without surgical intervention	—

Countries

Japan

Contacts

Public ContactTakashi Ibe

Gunma University Hospital Division of General Thoracic Surgery

t-ibe@gunma-u.ac.jp027-220-8224

Outcome results

None listed

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