An investigator-initiated phase II study in pleurodesis for secondary intractable pneumothorax with sterile graded talc

Phase 2

Completed

• Conditions: Patients with secondary intractable pneumothorax who are in surgical difficulty

• Registration Number: JPRN-jRCT1091220272
• Lead Sponsor: ational Hospital Organization Nagoya Medical Center Hideo Saka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Study Completion: 2021-06-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of chest tube removal.

Secondary Outcome Measures

Name	Time	Method
1.Disappearance/Decrease of air leakage<br>2.A grade of dyspnea (mMRC dyspnea scale) <br>3.Duration of drainage