bronchopleural fistula (BPF)
Conditions
Interventions
1) Blood collection to produce autologous serum for cell culture
2) Auricular cartilage tissue collection
3) Administration of implant-type regenerated cartilage to the responsible bronchus
Sponsors
Sakao Yukinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions: 1) Patients who obtain written consent for participation in this clinical study 2) Patients over 20 years old (male, female) 3) Patients who are clinically diagnosed as bronchopleural fistula (BPF) 4) Patients who are judged to be difficult for surgical treatment 5) Patient after fenestration for empyema 6) Patients without malignant tumor. Regarding lung cancer patients after treatment, patients without any clinical recurrence are included
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions: 1) Patients whose bronchus responsible to BPF cannot be identified in advance 2) Patients who have difficulty in approaching the responsible bronchus with bronchoscope 3) Poor-controlled diabetes 4) Patients with severe disease in the circulatory system, respiratory system, liver, kidney, blood 5) Patients with severe allergic diseases 6) Patients who are unable to administer antibiotics sufficiently due to drug allergies 7) Patients with visceral / blood malignant tumors (including during treatment, excluding cured cases) 8) Patients who are addicted to illegal drugs (such as narcotics) and alcohol 9) Compromised host with other comorbidities 10) Patients who participate in other clinical studies / clinical trials or participate in these within 24 weeks before obtaining consent 11) Female patients who are currently pregnant or breastfeeding and who do not agree with appropriate contraception for up to 24 weeks after surgery 12) Patients with syphilis, hepatitis B, hepatitis C, human immunodeficiency virus infection, human T cell leukemia virus infection 13) Patients with a history of autoimmune diseases such as Rheumatoid arthritis, psoriatic arthritis, systemic or discoid lupus erythematosus, dermatomyositis, polymyositis, chronic thyroiditis, Graves' disease, polyarteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter syndrome, mixed connective tissue disease, or relapsing polychondritis 14) Patients with a history of hypersensitivity or allergy to collagen or lactic acid-based polymer drugs, fibroblast growth factor (FGF), insulin, penicillin, streptomycin, amphotericin B, dexamethasone 15) Patients with positive intradermal test against atelocollagen 16) Patients who are clinically judged to be ineligible for this study due to other factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of bronchial embolization using CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmation of bronchial obstruction using bronchoscopy Check for the infection in the treated site Adverse events | — |
Countries
Japan
Contacts
Public ContactYukinori Sakao
Teikyo University School of Medicine
Outcome results
None listed