臨床研究等提出・公開システム

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

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

Kondo Takayuki

Chiba University Hospital

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture

takakon@chiba-u.jp

Fujimoto Kentaro

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture

+81-432227171

fujimoto.kentarou@chiba-u.jp

Recruiting

May. 14, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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.

Both

Portal hypertension with portal vein major circulation short circuit

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

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

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.

+81-43-226-2616

April. 15, 2024

No

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