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临床试验/NCT02256046
NCT02256046Unknown不适用

Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices; Multicenter Study

Tanta University2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
224
试验地点
2
主要终点
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

研究概览

简要总结

Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta University, in at least six months in the period from august 2014 to march 2015 or until the target number of patients reached whichever is longer.

详细描述

Portal hypertension is a common clinical syndrome, defined by a pathologic increase in the portal venous pressure, in which the hepatic venous pressure gradient (HVPG) is increased above normal values (1-5 mmHg). In cirrhosis, portal hypertension results from the combination of increased intrahepatic vascular resistance and increased blood flow through the portal venous system.

Esophageal variceal bleeding is one of the most serious complications of portal hypertension, and represents a leading cause of death in patients with cirrhosis. Each bleeding episode is associated with a 30% mortality rate.

Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding. EST consists of the injection of a sclerosing agent into the variceal lumen or adjacent to the varix, with flexible catheter with a needle tip, inducing thrombosis of the vessel and inflammation of the surrounding tissues. During active bleeding, sclerotherapy may achieve hemostasis, inducing variceal thrombosis and external compression by tissue edema. With repeated sessions, the inflammation of the vascular wall and surrounding tissues leads to fibrosis, resulting in variceal obliteration.

Furthermore, vascular thrombosis may induce ulcers that also heal, inducing fibrosis. There are technical variations in performing EST, such as type and concentration of the sclerosants, volume injected, interval between sessions, and number of sessions Endoscopic band ligation (EBL) is generally accepted as the treatment of choice for bleeding from esophageal varices. It has shown good results in terms of the control of the active bleeding, with few untoward effects.

Esophageal ulcerations ulcerations occur in the esophageal mucosa after all successful ligations. However, ulcers following Esophageal Variceal Ligation (EVL) are less severe than with ES.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with esophageal varices having upper GIT endoscopy

排除标准

  • Patients having endoscopy with no EVs

结局指标

主要结局

Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Shebl

Dr.

Tanta University

研究点 (2)

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