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临床试验/CTRI/2023/06/054442
CTRI/2023/06/054442已完成不适用

A randomized controlled trial to study the effect of PPI vs No-PPI after EVL on recurrent bleeding episodes in patients of liver cirrhosis with acute variceal bleeding

Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2023年1月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
To compare the rate of recurrent bleeding between PPI versus no PPI groups after EVL in liver cirrhosis patients with acute varicella bleed

研究概览

简要总结

Proton Pump Inhibitors (PPI) are extensively used in many acid related disorders due to their high efficacy in inhibiting gastric acid secretion. They are also often used in cirrhosis patients with variceal or portal hypertensive gastropathic bleeding to prevent peptic complications. The prevalence of varices is around 30% in compensated and 60% in decompensated cirrhotic patients. Apart from Child-Pugh score, the size of varices is also a risk factor for variceal bleeding where medium and large esophageal varices bleed at higher rate than small esophageal varices. Endoscopic variceal band ligation (EVL) is currently recommended therapy of choice in patients with acute variceal bleeding along with vasoconstrictors. Non selective beta blockers are also used along with EVL for primary as well as secondary prophylaxis of esophageal varices. There is a constant search going on for effective non-invasive therapies in patients with variceal bleed and PPIs owing to their safety profile and efficacy in non variceal bleed are being considered a candidate for the same. The latest Baveno VII guidelines also advise to stop PPIs after endoscopic therapy unless there is clear indication to continue them, but the level of evidence for the statement is very low and strength of recommendation is weak.

In this study we would aim to determine the effect of PPI on recurrent episodes of variceal bleeding after EVL in liver cirrhosis patients that would help making informed decision regarding the use of PPIs in cases with variceal bleeding.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of liver cirrhosis presenting with decompensation in the form of first episode of variceal bleed.

排除标准

  • 1-Refractory bleed requiring TIPSS or emergency surgery apart from EVL 2-Upper GI bleed due to acid peptic disease/GERD 3-Hepatocellular carcinoma 4-upper GI Bleed due to malignant tutors go the GI tract 5-Hemodynamic instability requiring vasopressor support 6-Hepatic encephalopathy grade III or above 7-History of surgery of oesophagus, stomach or liver 8- Renal failure with creatinine>2mg/dl 9-Presence of gastric varices as source of upper GI bleed 10-Pregnancy/breastfeeding 11-PPI allergy 12-Mising informed consent.

结局指标

主要结局

To compare the rate of recurrent bleeding between PPI versus no PPI groups after EVL in liver cirrhosis patients with acute varicella bleed

时间窗: From baseline till 12 weeks

次要结局

  • 1-Compare mortality between the 2 groups(2-Compare the size & number of post EVL ulcers at 2 weeks after first EVL session)

研究者

发起方
Post Graduate Institute of Medical Education and Research
申办方类型
Research institution and hospital

研究点 (1)

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