UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059859 |
|---|---|
| Receipt number | R000057458 |
| Scientific Title | Radio-Frequency-Ablation for lung cancer under general anesthesia |
| Date of disclosure of the study information | 2025/11/24 |
| Last modified on | 2025/11/23 13:16:40 |
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Basic information
Public title
Radio-Frequency-Ablation for lung cancer under general anesthesia
Acronym
Radio-Frequency-Ablation for lung cancer under general anesthesia
Scientific Title
Radio-Frequency-Ablation for lung cancer under general anesthesia
Scientific Title:Acronym
Radio-Frequency-Ablation for lung cance
Region
| Japan |
Condition
Condition
Malignant pulmonary tumors
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To increase accuracy of hitting radiofrequency ablation needle and decrease pain during the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control after radiofrequency ablation
Key secondary outcomes
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
Before radiofrequency for malignant pulmonary tumors, general anesthesia with tracheal intubation is conducted at CT room, following by radiofrequency ablation.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Primary lung tumors or metastatic lung tumors.
2.The tumor is smaller than 5cm, and the number of tumors is less than 5.
3. Standard therapy, such as surgery, chemotherapy, and radiation therapy, is hard to control the tumor.
4. Patients request the radiofrequency ablation rather than the standard therapy, such as surgery, chemotherapy, and radiation therapy.
5. Patients with multiple metastatic tumors, who are expected to survival long after radiofrequency ablation for large lung tumors.
6. Performance status is lower than 2.
Key exclusion criteria
1. Severe clinical symptoms.
2. Unsuitable status judged by doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
Kashiwa Kousei General Hospital
Division name
Thoracic Surgery
Zip code
2770862
Address
617 Shikoda, Kashiwa-city, Chiba prefecture
TEL
0471451111
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
Kashiwa Kousei General Hospital
Division name
Thoracic Surgery
Zip code
2770862
Address
Shikoda 617, Kashiwa-city, Chiba prefecture
TEL
0471451111
Homepage URL
https://www.kashiwakousei.or.jp/medical/klokyukigeka/
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital
Institute
Department
Personal name
Hiroaki Nomori, MD
Funding Source
Organization
None.
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
Kashiwa Kousei General Hospital, Ethics Committee
Address
Shikoda 617, Kashiwa-city, Chiba prefecture
Tel
0471451111
hnomori@qk9.so-net.ne.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
| 2025 | Year | 11 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057458
