UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040019 |
|---|---|
| Receipt number | R000045626 |
| Scientific Title | Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2020/04/24 14:16:20 |
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Basic information
Public title
Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Acronym
Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Scientific Title
Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Scientific Title:Acronym
Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Region
| Japan |
Condition
Condition
pulmonary malignancy
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the short- and long-term postoperative outcomes of robot-assisted surgery in respiratory surgery and to establish the utility and safety of robot-assisted surgery in respiratory surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative complications
Key secondary outcomes
Robotic surgery completion rate, intraoperative blood loss, operative time, length of hospital stay, medical costs, recurrence-free survival and overall 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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robotic-assisted surgery is performed using the da Vinci Surgical System x, and the target procedure is "thoracoscopic pulmonary malignancy surgery (resection of the lung lobes or more than one lung lobe with endoscopic surgical support equipment). It is. The treatment and diagnostic policies and the extent of lymph node dissection for lung cancer are in accordance with the 2018 edition of the Lung Cancer Practice Guidelines.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PS (Performance Status) is 0 or 1.
No prior treatment for the disease.
Consent to participate in the study has been obtained in writing.
Diagnosis of pulmonary malignancy has been obtained by preoperative imaging or pathological examination.
In the case of primary lung malignancy, preoperative imaging indicates that the clinical stage of lung cancer is stage I-II.
In the case of metastatic pulmonary malignancy, no metastasis is observed in organs other than the lung.
Key exclusion criteria
PS (Performance Status) is 0 or 1.
No prior treatment for the disease.
Consent to participate in the study has been obtained in writing.
Diagnosis of pulmonary malignancy has been obtained by preoperative imaging or pathological examination.
In the case of primary lung malignancy, preoperative imaging indicates that the clinical stage of lung cancer is stage I-II.
In the case of metastatic pulmonary malignancy, no metastasis is observed in organs other than the lung.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | HIDEKI |
| Middle name | |
| Last name | MATSUDAIRA |
Organization
The Jikei University School of Medicine
Division name
The Division of Thoracic Surgery, the Department of Surgery
Zip code
105-8461
Address
University Hall 2, 3-25-8, Nishi-Shimbashi, Minato-ku
TEL
0334331111
hideki.matsudaira@gmail.com
Public contact
Name of contact person
| 1st name | HIDEKI |
| Middle name | |
| Last name | MATSUDAIRA |
Organization
The Jikei University School of Medicine
Division name
The Division of Thoracic Surgery, the Department of Surgery
Zip code
105-8461
Address
University Hall 2, 3-25-8, Nishi-Shimbashi, Minato-ku
TEL
0334331111
Homepage URL
hideki.matsudaira@gmail.com
Sponsor or person
Institute
he Division of Thoracic Surgery, the Department of Surgery, the Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Division of Thoracic Surgery, the Department of Surgery, the Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku
Tel
0334331111
rinri@jikei.ac.jp
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
| 2020 | Year | 04 | Month | 14 | 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
| 2020 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045626
