UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028971
Receipt number R000033149
Scientific Title Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study
Date of disclosure of the study information 2017/09/04
Last modified on 2017/09/02 12:42:29

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Basic information

Public title

Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study

Acronym

Early chest tube removal after thoracoscopic lobectomy

Scientific Title

Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study

Scientific Title:Acronym

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

1st name
Middle name
Last name Ryoichi Nakanishi

Organization

Nagoya City University Hospital

Division name

Department of thoracic surgery

Zip code


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

1st name
Middle name
Last name Ryoichi Nakanishi

Organization

Nagoya City University Hospital

Division name

Department of thoracic surgery

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

TEL

052-853-8231

Homepage URL


Email

ryoichi@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Federation of National Public Service Personnel Mutual Aid Associations

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 06 Month 29 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name