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A phase II study of talc poudrage for patients with malignant pleural effusions

A phase II study of talc poudrage for patients with malignant pleural effusions - A phase II study of talc poudrage for patients with malignant pleural effusions

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014552
Enrollment
50
Registered
2014-07-14
Start date
2014-07-14
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

malignant pleural effusion

Interventions

Pleurodesis with talc poudrage (4g).

Sponsors

Nishichita General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Malignant pleural effusion confirmed by histopathology or cytology. 2. Symptomatic with malignant pleural effusion and needs intervention. 3. Relief of symptoms is expected with drainage of pleural effusion. 4. Life expectancy of 30 days or more. 5. ECOG PS is expected to be 0-2 after darainage of pleural effusion. 6. 20 years of age or older. 7. Written informed consent from patient is gained.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to talc. 2. Hypersensitivity to lidocaine hydrochrolide. 3. Severe infection. 4. Severe hypoxemia despite oxgen therapy. 5. Uncontrolled angina or heart failure. 6. Myocardical infarction within 30 days of consent. 7. Severe bleeding diathesis. INR > 2.0 or platelet <60000/mm3. 8. Severe pleural adhesion. 9. Indication for bilateral pleurodesis. 10. History of pleurodeis of affected side. 11. Preganant or during lactation. Patient who hopes to bear child, or who can not keep contraceptive maneuver. 12. Inappropriate to enter this trial judged by the physician in charge

Design outcomes

Primary

MeasureTime frame
Pleural effusion control rate 30 days after talc poudrage.

Secondary

MeasureTime frame
Pain, pyrexia, oxygen saturation, and flow rate of oxygen after talc poudrage. Adverse effect. Time to reccurence of pleural effusion.

Countries

Japan

Contacts

Public ContactKenya Yoshida

Nishichita General Hospital Department of Repiratory Medicine

kenyayoshida@minos.ocn.ne.jp0562-33-5500

Outcome results

None listed

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