Study of efficacy and safety of minocycline in pleurodesis

JRCT ID: jRCTs061210024

Registered date:15/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postoperative pulmonary fistula
• Date of first enrollment: 06/12/2021
• Target sample size: 19
• Study type: Interventional

Intervention(s)

Intrapleural administration of minocycline (300 mg) with 1% xylocaine 10 mL and 200 mL saline via chest tube
Second administration of minocycline if pulmonary fistula persists 3 days after the first administration

Outcome(s)

Primary Outcome

Frequency of removal of the chest tube after the protocol treatment (intrapleural administration of minocycline, up to twice)
If the recurrence of pulmonary fistula is observed within 1 week after the removal of the chest tube, such cases are omitted

Secondary Outcome

1) Frequency of adverse events
2) Time period until the recurrence of pulmonary fistula

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Cases with postoperative pulmonary fistula at the postoperative day 3
2) The drainage from the chest tube are not bloody, purulent or chylous, and the volume of the drainage for 24 hours is 300 mL or less
3) Age of 20 years or older
4) Signed informed consent

Exclude criteria

1) Allergy against minocycline
2) Other patients who are unfit for the study as determined by the attending physician

Related Information

• Primary Sponsor: Toyooka Shinichi