Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060210) titled 'Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride' on Jan. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Gifu University Hospital
Condition:
Condition - Bladder cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Hypotension is a side effect of transurethral resection of bladder tumors using photodynamic diagnosis with 5-aminolevulinic acid hydrochloride (5-ALA preparation, trade name: Alagrio Granules, 1.5g sachets). However, the mechanism of its occurrence remains largely unclear. This study investigates the relationship between the onset of hypotension and the blood concentration of vasodilator substances in patients undergoing PDD-TUR-Bt using 5-ALA.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Patients undergoing TUR-bt with spinal subarachnoid anesthesia starting January 1, 2025
2. Patients for whom written consent to participate in this study is obtained
Key exclusion criteria - 1. Patients from whom consent cannot be obtained
2. Other patients deemed unsuitable for the study at the physician's discretion
Target Size - 34
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 10 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068839
Disclaimer: Curated by HT Syndication.
