UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study
Title of the study (Brief title)	Early chest tube removal after thoracoscopic lobectomy
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate the safety of early chest tube removal after thoracoscopic lobectomy for lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events after early chest tube removal
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	Chest tube removal on postoperetive day 1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.A case that a document agreement by the examination participation 2.Patients with Eastern Cooperative Oncology Group performance status 0-2 3.Patients with suspected or histologically documented lung cancer 4.Consecutive patients for whom the preoperative intention was to perform a thoracoscopic anatomic pulmonary resection including a lobectomy or bilobectomy 5.Patients radiologically suspected of limited single-station N2 disease 6.Patients with preoperative stage IV, only treatable brain metastasis
Key exclusion criteria	1.Patients who underwent pneumonectomy
Target sample size	300

Research contact person
Name of lead principal investigator	Ryoichi Nakanishi
Organization	Nagoya City University Hospital
Division name	Department of thoracic surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-853-8231
Email	ryoichi@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Ryoichi Nakanishi
Organization	Nagoya City University Hospital
Division name	Department of thoracic surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-853-8231
Homepage URL
Email	ryoichi@med.nagoya-cu.ac.jp

Sponsor
Institute	Federation of National Public Service Personnel Mutual Aid Associations
Institute
Department

Funding Source
Organization	Federation of National Public Service Personnel Mutual Aid Associations
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国家公務員共済組合連合会　新小倉病院・浜ノ町病院・新別府病院

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 29 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 02 Day
Last modified on	2017 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033149