UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035261 |
|---|---|
| Receipt number | 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 17:44:42 |
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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
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
nagatosh@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040168
