Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Banding side effects at 6 weeks follow up
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis.
Researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival.
Participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. Index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. Patients will be randomly assigned to endoscopic band ligation (EBL) either by cross-section or stepladder techniques every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. For a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years.
- •Cirrhotic patients.
- •Endoscopic evidence of medium/large-sized esophageal varices.
排除标准
- •History of variceal bleeding or previous primary prevention of varices.
- •Portal vein thrombosis or previous porto-systemic shunts as TIPS.
- •Patients on drugs affecting portal pressure (beta blockers, nitrates).
- •Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia.
- •Patients with severe respiratory diseases (COPD, bronchial asthma).
- •Uncontrolled diabetes mellitus.
- •Renal impairment.
- •Hepatocellular carcinoma.
- •Allergy to carvedilol.
- •Pregnancy or lactation.
结局指标
主要结局
Banding side effects at 6 weeks follow up
时间窗: through study completion, an average of 1 year
Side effects of banding (e.g. post banding ulcers, portal hypertensive gastropathy, esophageal strictures and perforation) at 6 weeks will be evaluated and compared across the studied groups.
Vriceal bleeding rate at 6 weeks follow up
时间窗: through study completion, an average of 1 year
-The occurrence of first variceal bleeding (early bleeding within 3 - 10 days after band ligation and late bleeding after that) will be evaluated and compared across the studied groups.
Mortality rate at 6 weeks follow up
时间窗: through study completion, an average of 1 year
Bleeding-related mortality rate and overall mortality rate at 6 weeks will be assessed and compared across the studied groups.
次要结局
- Variceal recurrence rate at 6 months follow up(through study completion, an average of 1 year)
- Variceal obliteration rate at 6 months follow up(through study completion, an average of 1 year)
研究者
Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Tanta University