UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030358
Receipt number R000034591
Scientific Title An evaluation study of efficacy and safety of Robotic pulmonary lobectomy with Da Vinci Surgical System for Lung cancer
Date of disclosure of the study information 2017/12/15
Last modified on 2018/06/21 14:00:12

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Basic information

Public title

An evaluation study of efficacy and safety of Robotic pulmonary lobectomy with Da Vinci Surgical System for Lung cancer

Acronym

An evaluation of lung cancer surgery with Da Vinci

Scientific Title

An evaluation study of efficacy and safety of Robotic pulmonary lobectomy with Da Vinci Surgical System for Lung cancer

Scientific Title:Acronym

An evaluation of lung cancer surgery with Da Vinci

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of pulmonary lobectomy using Da Vinci Surgical System for lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Perioperative Morbidity and Mortality(Clavien-Dindo classification 2 or higher)

Key secondary outcomes

Surgical outcomes (operation time, volume of blood loss, and conversion rate to open surgery)


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

Interventions/Control_1

Pulmonary lobectomy with Da Vinci Surgical System

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) radiologically judged Stage I lung cancer
2) applicable to video-assisted pulmonary lobectomy
3) age 20 to 80 years
4) ECOG-Performance status of 0 to 1
5) written informed consent

Key exclusion criteria

1) history of thoracic surgery on ipsilateral side
2) severe cardiac or cerebral vascular disease
3) aspirin, warfarin or other medications induce bleeding tendency prohibited to discontinue
4) sever renal disfunction
5) severe hepatic disfunction
6) patients whose enrollement in this trial is judged to be inappropriate by the attending doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Yamazaki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Thoracic Surgery

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Email

yamazaki@kyumed.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Yamazaki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Thoracic Surgery

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Homepage URL


Email

yamazaki@kyumed.jp


Sponsor or person

Institute

National Hospital Organization Kyushu Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 15 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

2011 Year 11 Month 06 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 27 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 12 Month 12 Day

Last modified on

2018 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name