Efficacy and safety of PICIBANIL for pleurodesis against pulmonary fistula

JRCT ID: jRCTs031180293

Registered date:15/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Refractory pneumothorax and postoperative lung fistula
• Date of first enrollment: 30/08/2018
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Intrathoracic administration of Picibanil via the thoracic drain.

Outcome(s)

• Primary Outcome: Ratio of lung fistula that cured without surgical intervention
• Secondary Outcome: Ratio of serious adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Ohtaki Yoichi
• Source(s) of Monetary Support: Nippon Zoki Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000031104