Randomized Clinical Trial to study efficacy of adding on Sucralfate for prevention of post endoscopic variceal ligation (EVL) ulcer in patients with variceal bleeding
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
Esophageal variceal ligation (EVL) is performed to control variceal hemorrhage. Side effects of EVL include hemorrhage, chest pain, dysphagia, and odynophagia. Because gastric acid may exacerbate post-banding ulcers and delay healing, Sucralfate may decrease the side effects associated with EVL.
This study aims to assess the efficacy of Sucralfate as an adjunct to elective / emergency EVL.
We plan to perform an open-label randomized controlled trial of Sucralfate after EVL. Subjects in the sucralfate arm will receive 1g Sucralfate suspension (10ml) three times a day and 40mg of twice daily pantoprazole for 21 days. Control subjects will receive only oral pantoprazole 40mg twice daily for 21 days.
All subjects will undergo upper GI endoscopy 14 – 21 days after banding or if they present with a bleed episode earlier than the stipulated time.
At follow-up endoscopy, the mean number of ulcers and the ulcer dimensions will be measured and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Consecutive subjects presenting for elective / emergency variceal band ligation will be considered eligible for inclusion in the study.
- •Inclusion criteria are subjects with portal hypertension and varices between the ages of 18 and 80 years who has had a history of prior variceal hemorrhage.
- •Patients undergoing secondary EVL will only be recruited.
排除标准
- •The exclusion criteria for the study include patients with hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT), acute PVT, or intolerance to non-selective beta-blockers; those using anticoagulation or antiplatelet drugs; pregnant individuals or patients under 18 years of age; and those undergoing ongoing therapy with anti-acid agents or with a history of allergy or adverse reactions to proton pump inhibitors and/or sucralfate.
- •Additionally, patients with pre-existing esophageal ulcers, a history of surgical anti-reflux procedures (e.g., Nissen, Belsey, or Toupet), or Barrett’s esophagus are excluded, as are those undergoing primary endoscopic variceal ligation (EVL) or with a history of liver transplantation.
结局指标
主要结局
Primary Objective
时间窗: Primary Objective | 1. The number of esophageal ulcers identified at follow-up endoscopy | 2. The size of esophageal ulcers identified at follow-up endoscopy after EVL | Secondary Objective: | 1. Incidence of post-EVL ulcer bleed | 2. Delta hemoglobin after 21 days from the last scopy
1. The number of esophageal ulcers identified at follow-up endoscopy
时间窗: Primary Objective | 1. The number of esophageal ulcers identified at follow-up endoscopy | 2. The size of esophageal ulcers identified at follow-up endoscopy after EVL | Secondary Objective: | 1. Incidence of post-EVL ulcer bleed | 2. Delta hemoglobin after 21 days from the last scopy
2. The size of esophageal ulcers identified at follow-up endoscopy after EVL
时间窗: Primary Objective | 1. The number of esophageal ulcers identified at follow-up endoscopy | 2. The size of esophageal ulcers identified at follow-up endoscopy after EVL | Secondary Objective: | 1. Incidence of post-EVL ulcer bleed | 2. Delta hemoglobin after 21 days from the last scopy
次要结局
- Secondary Objective:(1. Incidence of post-EVL ulcer bleed)
研究者
Vijay Alexander
Christian Medical College Hospital