Tokyo, Aug. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062435) titled 'An observational study of endoscopic ultrasound-guided tissue sampling for solid pancreatic lesion' on Aug. 3.
Study Type:
Observational
Primary Sponsor:
Institute - Shiga university of medical science
Condition:
Condition - solid pancreatic lesion
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively collect and analyze data on tissue acquisition and pathological diagnosis in patients undergoing EUS-FNA with a novel FNB needle as part of routine clinical care for solid pancreatic Lesions.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Solid pancreatic lesion 10 mm or larger scheduled to undergo EUS-FNA as part of routine clinical care
Age 18 years or older
Written informed consent obtained from the patient
Key exclusion criteria - Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued
Platelet count of 50,000/uL or below, or PT-INR of 1.5 or higher or PT-INR of 1.5 or higher on blood testing within the preceding month
Previous upper gastrointestinal surgery (except Billroth I reconstruction)
Possible pregnancy
Patients in whom the novel FNB needle was not used for any reason
Patients judged inappropriate for the study by the principal or sub-investigators
Target Size - 65
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 22 Day
Anticipated trial start date - 2026 Year 08 Month 03 Day
Last follow-up date - 2027 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071388
Disclaimer: Curated by HT Syndication.
