UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035186 |
|---|---|
| Receipt number | R000040078 |
| Scientific Title | Sealing effects and safety of microwave surgical Instruments to dissect the lung parenchyma in the intersegmental plane in lung segmentectomy |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2020/12/10 14:45:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Sealing effects and safety of microwave surgical Instruments to dissect the lung parenchyma in the intersegmental plane in lung segmentectomy
Acronym
Sealing effects and safety of microwave surgical Instruments to dissect the lung parenchyma in the intersegmental plane in lung segmentectomy
Scientific Title
Sealing effects and safety of microwave surgical Instruments to dissect the lung parenchyma in the intersegmental plane in lung segmentectomy
Scientific Title:Acronym
Sealing effects and safety of microwave surgical Instruments to dissect the lung parenchyma in the intersegmental plane in lung segmentectomy
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety on lung segmentectomy, which involves dissecting the lung parenchyma using microwave surgical instruments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complications related to the lung parenchymal sealing
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with non-invasive cancer (=<2 cm) located at positions deeper than the pleural surface;
2) Patients with small-sized non-small cell lung cancer (the proportion of the maximum diameter of the tumor itself to consolidation is <25%); intentional segmentectomy
3) Elderly patients or patients with an insufficient pulmonary reserve, with or without other coexisting organ dysfunction (compromised segmentectomy)
4) Patients with a metastatic tumor or unknown nodule that was located in a central area.
Key exclusion criteria
Patients with severe emphysema or interstitial pneumonitis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mimura |
Organization
National hospital organization, Kure Medical Center and Chugoku Cancer Center
Division name
Department of Respiratory Surgery
Zip code
7340005
Address
3-1 Aoyama-cho, Kure
TEL
0823223111
t.mimura88@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mimura |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of General Thoracic Surgery
Zip code
7340005
Address
3-1 Aoyama-cho, Kure, Hiroshima
TEL
0823223111
Homepage URL
t.mimura88@gmail.com
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address
3-1, Aoyama-cho
Tel
0823223111
t.mimura88@gmail.com
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
国立病院機構呉医療センター・中国センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0003497520301909
Number of participants that the trial has enrolled
30
Results
The use of a MSI for lung parenchymal dissection was associated with lower blood loss during surgical procedures, reduced air leakage after the operation, and fewer postoperative complications.
Results date posted
| 2020 | Year | 12 | Month | 10 | Day |
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate efficacy and safety on lung segmentectomy, which involves dissecting the lung parenchyma using microwave surgical instruments.
Management information
Registered date
| 2018 | Year | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
