A randomized controlled trial to evaluate the efficacy of intra-pericardial instillation of a sclerosing agent after pericardial drainage in patients with malignant pericardial effusion associated with lung cancer (JCOG9811).

A randomized controlled trial to evaluate the efficacy of intra-pericardial instillation of a sclerosing agent after pericardial drainage in patients with malignant pericardial effusion associated with lung cancer (JCOG9811). - A randomized controlled trial to evaluate the efficacy of intra-pericardial instillation of a sclerosing agent after pericardial drainage in patients with malignant pericardial effusion associated with lung cancer (JCOG9811).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000030

Enrollment

Registered

2005-07-28

Start date

1999-08-01

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

Malignant pericardial effusion

Interventions

Observation alone after pericardial drainage Percardial instillation of bleomycin after pericardial drainage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)pathologically documented lung cancer 2)clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary to be documented by cytology) 3)expected to live 6 weeks or longer 4)sufficient organ function 5)signed informed consent

Exclusion criteria

Exclusion criteria: 1)Myocardial infarction or unstable angina within 3 months 2)constricitive pericarditis 3)active pneumonitis 4)severe infection or DIC 5)other severe co-morbidity which could not be relieved with pericardial drainage 6)chemotherapy-naive small cell lung cancer

Design outcomes

Primary

Measure	Time frame
Survival without pericardial effusion at 2 months	—

Secondary

Measure	Time frame
Succesful extubation of pericardial drainage tube, time to extubation, survival without pericardial effusion at 1,2,4,6,12months, symptom palliation, complication, long-term (>6months) effect on cardiac function.	—

Countries

Japan

Contacts

Public ContactHideo Kunitoh, M.D.

JCOG9811 Coordinating Office Medical Oncology Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

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