Clinical Trial on the Usefulness of EOI Forms in Balloom Occluded Retrograde Transvenous Obliteration

JRCT ID: jRCTs031240085

Registered date:14/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Portal hypertension with portal vein major circulation short circuit
• Date of first enrollment: 14/05/2024
• Target sample size: 28
• Study type: Interventional

Intervention(s)

Study drug treatment group: BRTO with EOI form.
Control group: BRTO using 5% EOI.

Outcome(s)

• Primary Outcome: Ratio of 5% EOI volume required for treatment to the volume of contrast agent used to delineate the portal hypervolemic short circuit on pretreatment contrast studies

Secondary Outcome

Technical success rate based on the evaluation by the responsible physician (assessed by contrast-enhanced CT scan after treatment).
Percentage of patients requiring additional embolization.
Treatment duration.
Frequency of adverse events.
Incidence of post-embolization syndrome (pain, fever, etc.).
General clinical laboratory tests (blood, urine), particularly changes in bilirubin levels, platelet count, and LDH due to hemolysis or intravascular coagulation.
Percentage of patients who exhibited hematuria after haptoglobin administration post-treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible
1) Patients with portal hypertension who have a portal hypertension short circuit
2) Patients who are 18 years of age or older at the time of consent
3) Patients scheduled to receive BRTO
4) Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study

Exclude criteria

The following individuals are not eligible for inclusion:

Patients with a serum creatinine (Cre) level measured in the 4 weeks before the start of the exam of 2.0 mg/dL or higher.
Patients classified as Grade C according to the Child-Pugh classification.
Patients with a known allergy to contrast agents.
Patients who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding.
Any other patients deemed unsuitable for the safe conduct of this trial by the principal investigator or participating physicians.

Related Information

• Primary Sponsor: Kato Naoya
• Secondary Sponsor: Kondo Takayuki
• Source(s) of Monetary Support: Chiba University Hospital Startup Support Fund