UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012103 |
|---|---|
| Receipt number | R000014033 |
| Scientific Title | Clinical evaluation of the safety and the usefulness of robot assisted lung lobectomy with nodal dissection for primary lung cancer. |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2013/10/22 22:57:29 |
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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
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
masataro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014033
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
