Tokyo, Nov. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059859) titled 'Radio-Frequency-Ablation for lung cancer under general anesthesia' on Nov. 24.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kashiwa Kousei General Hospital
Condition:
Condition - Malignant pulmonary tumors
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To increase accuracy of hitting radiofrequency ablation needle and decrease pain during the treatment.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Before radiofrequency for malignant pulmonary tumors, general anesthesia with tracheal intubation is conducted at CT room, following by radiofrequency ablation.
Eligibility:
Age-lower limit - 15
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057458
Disclaimer: Curated by HT Syndication.