Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy for the Control of Acute Variceal Bleeding in Patients With Liver Cirrhosis at a Tertiary Center in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Compare the 24-h group vs 72-h group
研究概览
简要总结
In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.
详细描述
In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.
Objective
To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of 18 years and older
- •Both genders,
- •Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C)
- •Acute variceal bleeding were included
排除标准
- •Patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases),
- •Presence of sepsis,
- •Multi-organ failure,
- •The requirement of continuous ionotropic or ventilatory support,
- •Bleeding disorders,
- •Hepatocellular carcinoma or other extrahepatic malignanc.
结局指标
主要结局
Compare the 24-h group vs 72-h group
时间窗: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event
Differences between groups at baseline were evaluated with Student's t-test test for continuous variables and proportions were compared using the Chi2 or Fisher test.
次要结局
未报告次要终点
研究者
GONZALEZ-OJEDA ALEJANDRO
Clinical Professor
Instituto Mexicano del Seguro Social