UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Feasibility Study of en-bloc Systemic Lymph nodes Dissection with Pulmonary Lobectomy for patients with resectable non-small-cell lung cancer
Title of the study (Brief title)	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	Masami Sato
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of General Thoracic Surgery
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	Toshiyuki Nagata
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of General Thoracic Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 02 Day
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

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Publication of results	Unpublished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