UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer.
Acronym	Clinical evaluation of the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer.
Scientific Title	Clinical evaluation of the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer.
Scientific Title:Acronym	Clinical evaluation of the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer.
Region	Japan

Condition
Condition	Primary lung cancer
Classification by specialty	Surgery in general Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of adverse events.
Key secondary outcomes	Operative duration. Blood loss. Completion rate of robot assisted lung lobectomy.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Robot assisted lung lobectomy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with pathologically proven primary non-small cell lung cancer 2) Patients who need surgery and are considered to be eligible for thoracoscopic surgery. 3) The primary tumor of less than 3cm in the greatest dimension were confirmed by computed tomography, and lymph-node involvement is not detected by PET-CT. The clinical stage is IA (T1aN0 or T1bN0). 4) The tumors that can be resected by single lobectomy 5) Performance Status (ECOG) of 0 or 1. 6) No history of operation at the ipsilateral thorax 7) Patients who agreed to participate in this study
Key exclusion criteria	1) Tight adhesion in the hemithorax. 2) significant bleeding tendency. 3) Compromised lung function. 4) Other reason.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kimikazu Hamano
Organization	Yamaguchi University Graduate School of Medicine.
Division name	Department of Surgery and Clinical Science.
Zip code
Address	1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505 Japan.
TEL	+81-836-22-2261
Email	surg-1@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masataro Hayashi
Organization	Yamaguchi University Graduate School of Medicine.
Division name	Department of Surgery and Clinical Science.
Zip code
Address	1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505 Japan.
TEL	+81-836-22-2261
Homepage URL
Email	masataro@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine.
Institute
Department

Funding Source
Organization	Yamaguchi University
Organization
Division
Category of Funding Organization	Other
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	山口大学医学部附属病院（山口県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2013 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2014 Year 01 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	2013 Year 10 Month 22 Day
Last modified on	2013 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014033

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.