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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035261
Receipt No. R000040168
Scientific Title A Feasibility Study of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy for patients with resectable non-small-cell lung cancer
Date of disclosure of the study information 2018/12/15
Last modified on 2018/12/14

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Basic information
Public title A Feasibility Study of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy for patients with resectable non-small-cell lung cancer
Acronym En-bloc Feasibility Study
Scientific Title A Feasibility Study of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy for patients with resectable non-small-cell lung cancer
Scientific Title:Acronym En-bloc Feasibility Study
Region
Japan

Condition
Condition Resectable non small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To comfirm the safety of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Perioperative complications
Key secondary outcomes Completion ratio of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy.
Operation time. Bleeding volume. Hospital stay. Drain indwelling time. Complication rate. Perioperative mortality rate. Complete resection ratio. overall survival. progression free survival.

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 en-bloc Systemic Lymph nodes Dissection with Pulmonary 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
85 years-old >=
Gender Male and Female
Key inclusion criteria Resectable non small cell lung cancer
Systemic Lymph nodes Dissection with Pulmonary Lobectomy
PS 0-1
Key exclusion criteria subjects with interstitial lung disease.
Receiving continuous systemic corticosteroid.
Patients poorly controlled diabetes.
Dementia or psychological disorder difficult to participate in this clinical study.
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Sato
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of General Thoracic Surgery
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima city, Japan
TEL 099-275-6490
Email masa3310@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Nagata
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of General Thoracic Surgery
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima city, Japan
TEL 099-275-6490
Homepage URL
Email nagatosh@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Kagoshima University Graduate School of Medical and Dental Sciences Department of General Thoracic Surgery
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
2018 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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