Patients with secondary intractable pneumothorax who are in surgical difficulty
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Clinical trial
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRATHORACIC
Dose per administratio
Sponsors
National Hospital Organization Nagoya Medical Center Hideo Saka
Kyorin University Hospital, Teikyo University Hospital, Nihon University Itabashi Hospital, St. Marianna University School of Medicine, Nagoya Medical Center, Nagoya City University Hospital, Japanese Red Cross Okayama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who are diagnosed with pneumothorax by chest radiography. (2)Patients with any underlying diseases which cause pneumothorax. (3)Patients whose air leakage lasts more than 7 days at the time of case registration without efficacy of thoracic drainage. (4)Patients who are in surgical difficulty at high risk of anesthesia and surgery due to low pulmonary function or other causes, or who experienced repeated relapse without efficacy of surgery with expected low therapeutic effect of second surgery. (5)20 years old or older patients at the time of acquisition of informed consent. (6)Patients who provided written consents for participation in this study by themselves.
Exclusion criteria
Exclusion criteria: (1)Patients with spontaneous pneumothorax, traumatic pneumothorax or iatrogenic pneumothorax. (2)Patients with a history of hypersensitivity to talc. (3)Patients with severe infection complications. (4)Patients under treatment for heart failure at the time of consent acquisition. (5)Patients with a history of myocardial infarction within 30 days before the time of consent acquisition. (6)Patients with advanced blood coagulation disorder. (7)Patients who are considered to require simultaneous pleurodesis on both sides. (8)Patients with postoperative pulmonary fistula. (9)Patients who are administered systemic corticosteroids (equivalent to 10 mg/day or more of prednisolone) at the time of case registration. (10)Patients with clinically expected sufficient efficacy only by bronchial embolization therapy with EWS. (11)Patients who are pregnant or nursing, who wish to become pregnant during the observation period, or who cannot control contraception. (12)Patients who participated in other trials within 6 months before the time of consent acquisition. (13)Patients whom the principal investigator or other investigators decided not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of chest tube removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Disappearance/Decrease of air leakage 2.A grade of dyspnea (mMRC dyspnea scale) 3.Duration of drainage | — |
Countries
Japan
Contacts
Public ContactYutaka Ito
National Hospital Organization Nagoya Medical Center, Clinical Research Center
Outcome results
None listed