Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061459) titled 'A Prospective Clinical Study on the Utility of EUS-guided Fine-Needle Aspiration for Right Hepatic Lobe Lesions' on May 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Aichi Cancer Center

Condition: Condition - Right Hepatic Lobe Lesions Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate the diagnostic performance, technical success rate, and safety of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for right hepatic lobe lesions. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - EUS-FNA

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Adequate major organ function (bone marrow, cardiac, hepatic, pulmonary, and renal function) is preserved. 2) Patients with a performance status suitable for endoscopy: ECOG Performance Status 0, 1, or 2. 3) Patients expected to survive for at least 4 weeks. 4) Written informed consent has been obtained from the patient. Key exclusion criteria - 1) Patients with a history of surgical resection of the right hepatic lobe. 2) Patients at high risk of bleeding: Platelet count = 1.5 APTT >= 1.5 times the upper limit of normal 3) Patients with gastrointestinal stenosis. 4) Patients with massive ascites in whom a safe puncture route cannot be secured. 5) Patients with active infection or uncontrolled cholangitis or sepsis. 6) Patients in whom the operator judges that lesion visualization or a safe puncture route cannot be achieved by EUS. 7) Patients deemed inappropriate for this study by the attending physician. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 17 Day Date of IRB - 2026 Year 03 Month 17 Day Anticipated trial start date - 2026 Year 05 Month 11 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070332

Disclaimer: Curated by HT Syndication.