Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059083) titled 'Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis' on Sept. 13.
Study Type:
Observational
Primary Sponsor:
Institute - Chiba Unoversity
Condition:
Condition - Patients with esophageal varices
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will explore the efficacy and safety of esophageal variceal ligation (EVL) for patients with esophageal varices, comparing outpatient treatment with conventional additional inpatient treatment.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria will be included:
1. Outpatient EVL Group (Prospective)
1) Patients for whom EVL treatment is indicated for esophageal varices
2) Patients aged 18 years or older at the time of consent
3) Patients who have received a thorough explanation of this study and, after fully understanding it, have provided their own voluntary written consent
2. Inpatient EVL Group (Retrospective)
1) Patients who underwent EVL as an inpatient at this facility between April 2022 and March 2025
Key exclusion criteria - Patients who meet any of the following criteria will not be eligible for this study.
1. Outpatient EVL Group (Prospective)
1. Patients who are deemed by the principal investigator or subinvestigator to be at high risk of bleeding and who should be hospitalized (patients with a varicose vein evaluation of F3 or RC3 or higher).
2. Patients undergoing regular medical care who the principal investigator or subinvestigator deems unsuitable for the safe implementation of this study.
2. Inpatient EVL Group (Retrospective)
1. Patients who received other treatments (e.g., EIS) concomitantly.
2. Patients whose treatment was discontinued after only one treatment.
3. Patients who expressed refusal to participate in this study through a disclosure document.
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 08 Month 18 Day
Date of IRB - 2025 Year 08 Month 18 Day
Anticipated trial start date - 2025 Year 09 Month 13 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067584
Disclaimer: Curated by HT Syndication.