Esophageal varices
Conditions
Interventions
endoscopic ultrasonography-guided balloon-occluded sclerotherapy
Sponsors
Kato Naoya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with esophageal varices 2) Child-Pugh score A or B 3) Age 20 years or older (any gender) 4) Patients who have been fully informed about the study and have given their voluntary written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Renal dysfunction with an eGFR of less than 30 (excluding dialysis patients). 2) The patient who has one of the following cardiac diseases a) Heart failure of NYHA class 3 or higher. b) Current symptomatic coronary artery disease or a history of myocardial infarction within 4 weeks prior to enrollment. 3) Serious and active infection (CTCAE version 4.0 Grade 3 or higher) 4) Pregnant women, lactating women, and women who may or will become pregnant (if pregnancy is suspected, a pregnancy test should be performed). 5) Other risks that may jeopardize patient safety or make it difficult to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events causally related to treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of non-serious adverse events causally related to treatment Completion rates for treatment of esophageal varices with ultrasound endoscopy alone A recurrence rate of esophageal varices Number of endoscopic treatment sessions, amount of sclerosing agent used, and number of days in the hospital Changes in Child-Pugh score and ALBI score before and after treatment of esophageal varices Changes in portal vein main stem blood flow velocity and liver elasticity before and after treatment of esophageal varices | — |
Contacts
Public ContactTakayuki Kondo
Chiba University Hospital
Outcome results
None listed