Portal hypertension with portal vein major circulation short circuit
Conditions
Interventions
Study drug treatment group: BRTO with EOI form.
Control group: BRTO using 5% EOI.
Sponsors
Kato Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactHidemi Unozawa
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
Outcome results
None listed