Tokyo, Feb. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060703) titled 'A multicenter prospective comparative study of 19G Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) needles for mediastinal and intraperitoneal lymphadenopathy' on Feb. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Other
Condition:
Condition - mediastinal or abdominal lymphadenopathy
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the diagnostic ability and safety of 19G FNA/FNB needles for mediastinal or intraperitoneal lymphadenopathy
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 19G FNA needle
Interventions/Control_2 - 19G FNB needle
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Cases with mediastinal or abdominal lymphadenopathy detected by CT or ultrasound imaging.
2. Cases with lymphadenopathy without a pathological diagnosis.
3. Patients aged 18 years or older.
4. Lymphadenopathy of 10mm or greater.
5. Patients not taking oral anticoagulants.
Key exclusion criteria - 1. Cases in which a pathological diagnosis of lymph node swelling has already been made
2. Cases in which endoscopic examination is difficult
3. Cases in which consent to participate in this study cannot be obtained
4. Other cases in which this study is considered medically inappropriate
Target Size - 160
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 02 Month 18 Day
Date of IRB - 2026 Year 02 Month 04 Day
Anticipated trial start date - 2026 Year 02 Month 18 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069441
Disclaimer: Curated by HT Syndication.
