A Prospective Phase II Multicenter Study for Prophylaxis of Acute Exacerbations of Interstitial Lung Disease after Lung Cancer Resection

A Prospective Phase II Multicenter Study for Prophylaxis of Acute Exacerbations of Interstitial Lung Disease after Lung Cancer Resection - Sivelestat sodium Hydrate with low dose methylprednisolone for prevention of postoperative Interstitial Pneumonia (SHIP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008277

Enrollment

Registered

2012-06-29

Start date

2012-07-01

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

Interstitial pneumonia Lung cancer

Interventions

Just before general anesthesia, intravenous infusion of methylprednisolone and continuous drip of sivelestat sodium hydrate are administered.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed or suspected lung cancer 2)cStage IA-IIIA, resectable 3)lobectomy or segmentectomy is planned 4)the case diagnosed as suspicious of interstitial pneumonia by one radiologist and pulmonologist. Honeycomb or fibrosis just under the pleura three or more segments in both lower lobe with high resolution computed tomography. 5)performance status of 0 to 1 6)No incidence of chest irradiation or chemotherapy. 7)Adequate hematologic, hepatic, renal, and cardiac function. WBC >=4,000/mm3 Absolute neutrophil count 2,000/mm3 Platelet count >=100,000/mm3 Hemoglobin >=10.0g/dL AST and ALT <80IU/L Total bilirubin <1.5mg/dL Creatinine 1.5 <1.3gm/dl PaO2>=70Torr(room air) Predicted postoperative FEV1>=0.8L. %DLco>=40% 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of cancer treatment within 5 years (except carcinoma in situ). History of radiation therapy (which include a lung in the treatment field) or chemotherapy. 2)Severe comorbidities (uncontrolled ischemic heart disease or myocardial infarction within three months. Uncontrolled diabetes, hypertension and infection) 3)Pregnant ladies, nursing ladies, the ladies with possibility of pregnancy. 4)Patients who takes steroid therapy 5)Treatment history of interstitial pneumonia with pirfenidone.

Design outcomes

Primary

Measure	Time frame
Incidence of acute exacerbation of interstitial pneumonia within 30 days after lung cancer surgery	—

Secondary

Measure	Time frame
Pathological accuracy of interstitial pneumonia, Postoperative morbidity and mortality, Overall survival rate, Disease free survival rate, Incidence of secondary lung cancer.	—

Countries

Japan

Contacts

Public ContactHiroyuki Ito

Kanagawa Cancer Center Thoracic Surgery

h-ito@kcch.jp045-520-2222

Outcome results

None listed

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