臨床研究等提出・公開システム

Date of registration	Jan. 07, 2022
Last modified on	Jan. 07, 2022
Trial ID	jRCT1030210541

Scientific Title	Safety and feasibility of non-anatomical lung resection and intrathoracic tumor biopsy/resection without postoperative chest tube
Public Title	Safety and feasibility of wedge resection and intrathoracic tumor resection without postoperative chest tube

Contact for Scientific Queries	Name	Igai Hitoshi
	Affiliation	Japanese Red Cross Maebashi Hospital
	Address	389-1 Asakura, Maebashi City, Gunma
	Telephone	+81-272653333
	E-mail	hitoshiigai@gmail.com
Contact for Public Queries	Name	Igai Hitoshi
	Affiliation	Japanese Red Cross Maebashi Hospital
	Address	389-1 Asakura, Maebashi City, Gunma
	Telephone	+81-9028913877
	E-mail	hitoshiigai@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 01, 2021
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Scheduled for non-anatomical lung resection Scheduled for intrathoracic tumor biopsy/resection Written, informed consent has been obtained.
	Exclusion Criteria	Dense pleural adhesions (more than one lobe) History of ipsilateral anatomical lung resection Air leak intraoperative sealing test Blood loss over 100 ml Underlying lung disease (sever emphysema, interstitial pneumonia, etc) Air leaks from the end of the surgery to awakening from anesthesia
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Lung tumor, Primary spontaneous pneumothorax, Mediastinal tumor, Chest wall tumor
Intervention(s)		After resection of targeted tumor, the lung is immersed in warm sterile saline, ventilated at a maximum inspiratory pressure of 15 cmH2O, and examined for air leaks. If there is an air leak in this sealing test, this patient will be excluded from the study. A 20-Fr trocar catheter is placed in the thoracic cavity with continuous suction (7 cmH2O). Patients are returned to the supine position after surgery. We check the lung expansion using a routine portable chest X-ray before awakening the patient from anesthesia. Confirming that the lung expansion is good and that there is no air leak, we remove the chest tube immediately after extubation in the operating room. If there are air leaks during this time, the patient will be excluded from the study, and the chest tube will be left in place. Postoperative day 1:We assess wound pain using a numerical rating scale (NRS) the next morning. After checking lung expansion by a chest X-ray, the patient will be discharged. Postoperative day 7:We assess the wound pain using a numerical rating scale and check lung expansion by a chest X-ray.
Health Condition(s) Keyword		Lung tumor, Primary spontaneous pneumothorax, Mediastinal tumor, Chest wall tumor
Intervention(s) Keyword		Without postoperative chest tube
Primary Outcome(s)		Incidence of pneumothorax requiring chest tube reinsertion
Secondary Outcome(s)		Postoperative hospitalization Postoperative pain score

Primary Sponsor	Japanese Red Cross Maebashi Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical ethics committee
Address	389-1 Asakura, Maebashi City, Gunma, Gunma
Telephone	+81-272653333
E-Mail	nmori1130@gmail.com
Approval Status	Approval
Date of approval	Nov. 24, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none