Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean increase in hemoglobin levels from baseline
研究概览
简要总结
Gastric Antral Vascular Ectasia (GAVE) is an erosive form of gastritis distinguished by veno-capillary ectasia, which manifests as tortuous columns of dilated vessels. Histologically, these vessels show dilated mucosal capillaries filled with fibrin thrombi, accompanied by fibromuscular hyperplasia and spindle cell proliferation of the lamina propria. GAVE is prevalent in about 12% of patients with cirrhosis, with 60-70% of these patients becoming transfusion-dependent due to severe anaemia caused by GAVE related bleeding. The most commonly used treatment for GAVE is endoscopic therapy using Argon Plasma Coagulation (APC), which, while effective, often requires multiple sessions due to a high recurrence rate of 30-60%. These frequent interventions increase the burden on patients and healthcare systems. As a result, alternative treatments have been sought. Thalidomide, known for its potent antiangiogenic properties, significantly lowers vascular endothelial growth factor (VEGF) levels, offering a promising non-invasive treatment option. Early studies, such as those by García-Pagán have demonstrated thalidomide's effectiveness in reducing transfusion requirements and managing bleeding in cirrhotic patients with GAVE, yet its comprehensive efficacy and safety profile remains under-studied. This project aims to rigorously evaluate the efficacy and safety of thalidomide compared to APC in managing GAVE-related anemia in cirrhotic patients. Through a controlled trial, this study will provide vital data to potentially shift treatment paradigms, enhance patient quality of life, and reduce the need for repetitive invasive procedures.
详细描述
Aim: To evaluate and compare the efficacy and safety of thalidomide with argon plasma coagulation (APC) in managing gastric antral vascular ectasia (GAVE)-related anaemia in patients with cirrhosis.
Hypothesis: Thalidomide, due to its antiangiogenic effects, will more effectively reduce GAVE-related bleeding, improve haemoglobin levels, and decrease transfusion dependency compared to APC in patients with cirrhosis and GAVE-related anaemia.
Study Design:
Single-centre, open-label, randomised controlled trial to compare the efficacy and safety of thalidomide versus argon plasma coagulation (APC) in managing GAVE-related anaemia in cirrhotic patients.
Study Population:
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged ≥18 - 65years)
- •Endoscopically confirmed diagnosis of GAVE
- •+/- GAVE with active ooze
- •Iron deficiency anemia*
- •Ability to provide informed consent
排除标准
- •Active GI Bleeding is caused by a cause other than GAVE.
- •Renal insufficiency ( Creatinine >3mg/dL and/or on RRT)
- •Pregnancy or childbearing age
- •Contraindications to thalidomide therapy: Severe peripheral neuropathy or seizures or a history of thromboembolic disease.
- •Use of antiangiogenic drugs
- •Bevacizumab, steroids, octreotide
- •Severe cardiopulmonary disorders
- •H/o thalidomide use in the past 3months
- •Contraindications to APC: Coagulopathy( Pacemaker or implantable defibrillator, Platelet <45000, INR: >1.8 )
- •Overt Hepatic Encephalopathy
研究组 & 干预措施
Thalidomide Group
Patients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months.
干预措施: Thalidomide (Drug)
APC Group
Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required.
干预措施: Argon Plasma Coagulation (Procedure)
结局指标
主要结局
Mean increase in hemoglobin levels from baseline
时间窗: 4 months
次要结局
- Atleast 50 percent change in requirement of PRBCs transfusions at the end of 4 months(4 months)
- Change in GAVE related bleeding episodes at the end of 4 months(4 months)
- Duration of days of hospitalization due to GAVE related anemia in 4 months(4 months)
- Increase in serum iron levels, percent transferrin saturation at the end of 4months(4 months)
- Change in amount of PRBC's transfused at the end of 4 months.(4 months)
- Number of hospitalizations due to GAVE related anemia, in 4 months(4 months)
- Need of rescue endoscopic sessions in 4 months in thalidomide group(4 months)
- Endoscopic resolution of GAVE at the end of 4 months(4 months)
- Change in VEGF levels in Thalidomide group at the end of 4 months(4 months)
- Change in pepsinogen levels in Thalidomide group at the end of 4 months(4 months)
- Change in gastrin levels in Thalidomide group at the end of 4 months(4 months)
- Adverse events in each group at the end of 4 months(4 months)
- Quality of life measures - Short Form 36(4 months)