A Multicenter, Prospective, Randomized Controlled Study on EUS-Guided Precise Disconnection of Varices Versus Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.

Обзор

The purpose of this clinical trial is to evaluate whether Endoscopic Ultrasound-Guided Selective Variceal Devascularization (EUS-SVD) is effective in preventing the re-bleeding of gastric varices. It will also investigate the safety of EUS-SVD. The main questions it aims to answer are: Does EUS-SVD lead to a greater reduction in the one-year gastric variceal re-bleeding rate among participants compared to conventional Endoscopic Gastric Variceal Obturation (GVO)? What medical problems (adverse events) do participants experience when receiving EUS-SVD treatment? Researchers will compare EUS-SVD with GVO (a currently commonly used first-line treatment method) to see if EUS-SVD can be a superior option for treating gastric varices. Participants will: Be randomly assigned to undergo either the EUS-SVD or the GVO procedure. Receive treatment in the hospital and be hospitalized for observation (approximately 5 days for the EUS-SVD group, 3 days for the GVO group). Return to the hospital for a follow-up gastroscopy or endoscopic ultrasound examination at 3 months after the procedure. Receive telephone or outpatient follow-ups at 6 months and 12 months after the procedure to report their health status and any bleeding episodes. Throughout the study period, record and report any re-bleeding events, need for re-intervention, and other complications.

Вмешательства

• Процедура EUS-Guided Precise Disconnection of Varices
  EUS-SVD is an advanced, minimally invasive endoscopic interventional technique. It leverages the unique advantages of endoscopic ultrasound to precisely locate and completely block the "source" blood vessels responsible for gastric varices, thereby achieving the goal of preventing and treating bleeding.

Первичные конечные точки

• Gastric variceal bleeding within 1 year. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Chinese population aged 18-80 years;
• High-risk gastric varices confirmed by gastroscopy (for primary prevention) or active bleeding due to gastric varices or a history of acute gastric variceal bleeding within the past 1 month (for secondary prevention);
• Subjects who prefer endoscopic treatment and voluntarily sign the informed consent form.

Критерии исключения

• (1) Subjects with a history of secondary preventive treatment for gastric varices or shunt surgery; (2) Subjects complicated with hepatorenal syndrome, hepatic encephalopathy grade III/IV, or severe jaundice (serum bilirubin >10 mg/dl); (3) Subjects complicated with multiple organ failure or advanced malignant tumors; (4) Subjects who are pregnant, in gestation, or lactating; (5) Subjects suspected of having splenic vein or portal vein thrombosis; (6) Subjects with coagulation dysfunction, platelet count <50,000/mL or INR ≥2; (7) Subjects with esophageal stenosis or a history of esophageal or gastric surgery; (8) Subjects deemed unsuitable for this study by physician evaluation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07532915 · NFEC-2023-454

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗