Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis

Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis - Observational study on the efficacy and safety of esophageal variceal ligation performed solely on an outpatient basis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059083

Enrollment

Registered

2025-09-13

Start date

2025-09-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with esophageal varices

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Primary Endpoints Safety of outpatient esophageal variceal ligation 1. Post-treatment esophageal variceal bleeding rate 2. Post-treatment mortality rate	—

Secondary

Measure	Time frame
Secondary Endpoints [Secondary Efficacy Endpoints] 1. Post-treatment recurrence rate during the observation period. Definition of recurrence: ES morphology F1 or higher or RC sign observed on post-treatment endoscopic examination. [Secondary Safety Endpoints] 1. Comparison of safety between initial and subsequent additional treatments. Exploratory Endpoints 1. Correlation between patient characteristics and post-treatment esophageal variceal recurrence rate, esophageal variceal bleeding rate, and mortality rate. 2. Differences in recurrence rate due to prior esophageal variceal treatment and esophageal variceal bleeding history.	—

Measure

Time frame

Secondary Endpoints [Secondary Efficacy Endpoints] 1. Post-treatment recurrence rate during the observation period. Definition of recurrence: ES morphology F1 or higher or RC sign observed on post-treatment endoscopic examination. [Secondary Safety Endpoints] 1. Comparison of safety between initial and subsequent additional treatments. Exploratory Endpoints 1. Correlation between patient characteristics and post-treatment esophageal variceal recurrence rate, esophageal variceal bleeding rate, and mortality rate. 2. Differences in recurrence rate due to prior esophageal variceal treatment and esophageal variceal bleeding history.

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Countries

Japan

Contacts

Public ContactHidemi Unozawa

Chiba University Hospital Gastroenterology

unozawa.hidemi@chiba-u.jp0432227171

Outcome results