Clinical Trial: Uniportal Video-assisted thoracoscopic surgery Assessment for Lung cancer Validity and Efficiency: a multicentre, single-arm, prospective confirmatory study (JUVIG 2601) (Japan)

Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063340) titled 'Uniportal Video-assisted thoracoscopic surgery Assessment for Lung cancer Validity and Efficiency: a multicentre, single-arm, prospective confirmatory study (JUVIG 2601)' on Oct. 19.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Japan Uniportal VATS Interest Group

Condition: Condition - cStage IA1-2 Non-Small Cell Lung Cancer (NSCLC, cT1a-bN0M0) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the oncological validity (efficacy) and safety of uniportal video-assisted thoracoscopic anatomical lung resection (lobectomy and segmentectomy) for cStage IA1-2 early-stage non-small cell lung cancer. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Uniportal video-assisted thoracoscopic anatomical lung resection (lobectomy or segmentectomy) using a single incision = Gender - Male and Female Key inclusion criteria - Chest CT within 56 days prior to registration confirming cT1a-bN0M0 Stage IA1-2, deemed resectable by uniportal VATS anatomical lung resection (lobectomy or segmentectomy). Number of sub-tumors = 38 deg C at registration. Pregnant, possibly pregnant, or lactating women. Psychiatric disease or symptoms making study participation difficult. Ongoing systemic administration of corticosteroids or immunosuppressive agents. Uncontrolled diabetes mellitus or hypertension. Severe cardiac disease, heart failure, or history of myocardial infarction/angina within 6 months. Complication of interstitial pneumonia, pulmonary fibrosis, or severe emphysema Target Size - 600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 17 Day Anticipated trial start date - 2026 Year 10 Month 23 Day Last follow-up date - 2036 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072495

Disclaimer: Curated by HT Syndication.