Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding

Официальное название

Efficacy and Safety of Contrast Endoscopic Ultrasound-Guided Tissue Glue/Coil Devascularization vs. Balloon-Occluded Retrograde Transvenous Obliteration for Preventing Recurrent Gastric Variceal Bleeding: A Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are: Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment? Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications. Participants will: Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.

Вмешательства

• Процедура EUS-guided tissue glue/coil injection
  Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.
• Процедура BRTO
  Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.

Первичные конечные точки

• One-year all-cause rebleeding rate [Срок оценки: one year]

Критерии участия

Критерии включения

• Aged between 18 and 75 years old;

• Liver cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);

• Experienced bleeding of gastroesophageal varices (GVs) (GOV1, GOV2, or IGV1) within 5 days to 1 year (bleeding lesions observed under endoscopy originating from GVs, or no other bleeding lesions except GVs were found);

• Presence of spontaneous portosystemic shunts that are technically feasible for BRTO; ⑤ Willing to participate in this clinical study, comply with the study requirements, and sign the informed consent form.

Критерии исключения

• Previously received vascular interventional therapy for preventing rebleeding of GVs;

• Eligible for variceal ligation treatment of GOV1;

• Non-cirrhotic portal hypertension (including regional portal hypertension);

• Previously underwent surgical and interventional shunt procedures;

• Presence of contraindications to endoscopic or interventional treatment; ⑥ Extensive portal vein thrombosis, cavernous transformation of the portal vein;

⑦ Massive ascites;

⑧ Concurrent advanced liver cancer or other malignant tumors with a predicted lifespan of less than 3 months;

⑨ Concurrent severe diseases of other organs such as the heart, lungs, and kidneys;

⑩ Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• 37 Guoxue Lane — Чэнду

Идентификаторы

NCT: NCT07049146 · 2025 Audit No. 670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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