Bronchial embolization using regenerated cartilage

Not Applicable

• Conditions: bronchopleural fistula (BPF)

• Registration Number: JPRN-jRCTb032200013
• Lead Sponsor: Sakao Yukinori

Brief Summary

Regenerated cartilage could be useful and utilized as a bronchial embolization device,however, the long-term fixation method remained challenging.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Study Completion: 2021-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of bronchial embolization using CT scan

Secondary Outcome Measures

Name	Time	Method
Confirmation of bronchial obstruction using bronchoscopy<br>Check for the infection in the treated site<br>Adverse events