Safety and efficacy of endoscopic ultrasonography-guided sclerotherapy

JRCT ID: jRCT1032200110

Registered date:09/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal varices
• Date of first enrollment: 25/09/2020
• Target sample size: 6
• Study type: Interventional
• Intervention(s): endoscopic ultrasonography-guided balloon-occluded sclerotherapy

Outcome(s)

• Primary Outcome: Incidence of serious adverse events causally related to treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kato Naoya