Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery

JRCT ID: jRCTs051180052

Registered date:08/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 02/09/2015
• Target sample size: 335
• Study type: Interventional

Intervention(s)

arm A:Lung cancer surgery with hANP treatment [Patients in the hANP group receive human ANP (0.025 microgram/kg/min for 72hours), which is started more than two hours before surgery]
arm B:Lung cancer surgery alone

Outcome(s)

• Primary Outcome: Relapse-free survival (RFS)

Secondary Outcome

1. Five-year relapse free survival after lung cancer surgery
2. Over all survival (5 years after surgery)
3. The ratio of the patients who completed the treatment
4. The incidence of postoperative complications

Key inclusion & exclusion criteria

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

Include criteria

1. Non-small cell lung cancer is suspected.
2. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is more than 0.25.
3. It's possible to perform the complete resection.
4. Lymph node dissection more than ND2a or selective lymph node dissection
5. Patient without simultaneous or metachronous (within the past 5 years) double cancers.
6. Aged more than 20 years
7. Performance status of 0-2.
8. Sufficient organ function matching following criteria,
neutrophil count: more than 1500 /uL
platelet count: more than 100000 /uL
hemoglobin: more than 8.0 g/dL
AST and ALT: less than 100 IU/L
total bilirubin: less than 1.5mg/dL
SpO2 (under room air): more than 92%
9. All patients gave written informed consent

Exclude criteria

1. Patient with active the other concurrent malignant diseases.
2. Women during pregnancy or breast-feeding.
3. Psychosis.
4. Systemic steroids or immunosuppressive agents medication.
5. Uncontrollable infectious disease
6. Uncontrollable severe comorbidities.
7. Uncontrollable autoimmune disease
8. History of right ventricular infarction.
9. Severe hypotension
10. Dehydration that continues though patient receives treatments.
11. Other conditions judged ineligible by physician

Related Information

• Primary Sponsor: Shintani Yasushi
• Source(s) of Monetary Support: SHIONOGI & CO., LTD.,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000018480