Feasibility study of an endobronchial closure for pulmonary air leakage

JRCT ID: jRCTs041240154

Registered date:20/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: pneumothorax
• Date of first enrollment: 20/12/2024
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Under local anesthesia, advance an existing large bronchoscope to the bronchi that can be reached.
From there, insert an ultra-thin endoscope (video flexible bronchoscope) and guide sheath through the forceps channel of the large bronchoscope and maneuver them to reach the responsible lesion (bleb).
Upon reaching the responsible lesion (bleb), withdraw the ultra-thin endoscope and replace it with a catheter for drug injection.
Inject fibrin glue through the catheter, completing the procedure.

Outcome(s)

Primary Outcome

Incidence of complications judged to be related to fibrin glue injection within the two-week period following the procedure.
Complications include atelectasis, pneumonia, and other adverse events deemed related to fibrin glue injection.
The incidence of these complications will be evaluated according to CTCAE version 5.0.

Secondary Outcome

Incidence of complications (CTCAE version 5.0) judged to be related to fibrin glue injection during the entire observation period.
Incidence of complications (CTCAE version 5.0) judged to be related to the use of investigational medical devices (ultra-thin endoscope, guide sheath, and catheter for drug injection) during the entire observation period.
Incidence of adverse events (CTCAE version 5.0) during the entire observation period.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The patient must meet all of the following criteria:

Age 16 years or older at the time of registration.
Performance status (PS) of 0 or 1, according to the ECOG criteria.
Clinically diagnosed with spontaneous pneumothorax.
Surgical treatment for spontaneous pneumothorax is being considered.
A responsible lesion (bleb) in the affected lung apex is identified as a solitary finding on CT imaging.
No history of thoracic surgery.
Major organ functions are preserved.
Written informed consent for participation in the study is obtained from the patient, or from both the patient and their family if the patient is under 18 years of age.
A chest drain has been placed, and air leakage is observed.
In routine clinical practice, surgery would be considered as a treatment option for pneumothorax, rather than as part of a clinical trial.

Exclude criteria

Complicated by pulmonary fibrosis, interstitial pneumonia, or severe emphysema.
Has an active infection.
Female patients who may be pregnant or are breastfeeding.
Has a psychiatric disorder or psychiatric symptoms that may make participation in the study difficult.
Under continuous systemic steroid therapy (oral or intravenous).
Complicated by uncontrolled diabetes mellitus.
Complicated by uncontrolled hypertension.
Has a history of at least one of the following: severe heart disease, heart failure, myocardial infarction within the past 6 months, or angina pectoris attack within the past 6 months.

Related Information

• Primary Sponsor: Chen-Yoshikawa Fengshi Toyofumi
• Source(s) of Monetary Support: Nagoya University Hospital