NCT03705078已完成不适用
A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 20
- 主要终点
- Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
研究概览
简要总结
The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used.
- •Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following criteria: endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources.
- •Hemodynamically stable patient (Mean arterial pressure above 65 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
- •Written informed consent obtained.
排除标准
- •Pregnant woman or breastfeeding.
- •Minor and patients older than 75 years.
- •Non cirrhotic portal hypertension.
- •Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
- •Child Pugh score >
- •History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
- •Congestive heart failure.
- •History or presence of pulmonary hypertension.
- •Patients with other indication for TIPS.
- •Uncontrolled gastric variceal bleeding.
- •Portal vein cavernoma.
- •Patient who have previously received a TIPS procedure.
- •Failure to receive clear information in patients without an identified trusted person.
- •Refusal of the participation agreement by signing the information form and consent as defined.
- •Exclusion period from another biomedical study.
研究组 & 干预措施
early TIPS
Other
Transjugular portosytemic shunt within 72h
干预措施: Transjugular Portosytemic Shunt (TIPS) (Procedure)
Glue obliteration
Other
glue obliteration repeated sessions
干预措施: glue obliteration (Procedure)
结局指标
主要结局
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
时间窗: 12 months
Defined by Baveno VI consens group as a recurrent melena or hematemesis resulting in any of the following: * Hospital admission * Blood transfusion * 3 g/dL drop in hemoglobin
death
时间窗: 12 months
次要结局
- All-cause mortality and liver-related mortality(12 months)
- Incidence of rebleeding(12 months)
- Frequency of TIPS complications(12 months)
- MELD score (Model for End Stage Liver Disease) in TIPS group(6 months)
- Frequency of glue obliteration complications(12 months)
- MELD score (Model for End Stage Liver Disease) in glue obliteration group(6 months)
- Cumulative number of packed red blood cells(12 months)
- Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up(12 months)
- Number of days of hospitalization(12 months)
- All-cause mortality and liver-related mortality(Day 42)
- Incidence of rebleeding(Day 42)
- Incidence of rebleeding(Day 90)
- Incidence of rebleeding(3 months)
- Cumulative number of packed red blood cells(Day 42)
研究者
研究点 (20)
Loading locations...
相似试验
Unknown
不适用
Compare Early With Deferred Invasive Strategy for STEMI Presenting 24-48 Hours From Symptom OnsetST-segment Elevation Myocardial Infarction (STEMI)NCT04575012Shanghai Zhongshan Hospital1,200
已完成
不适用
Prospective Multicenter Trial of Early Versus Late Drain Removal After PancreaticoduodenectomyPancreaticoduodenectomyDrainageNCT03055676Peking Union Medical College Hospital319
招募中
2 期
Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line ImmunotherapyNSCLC Stage IVNCT06313541Fudan University146
进行中（未招募）
2 期
Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After ProstatectomyAdenocarcinoma of ProstateNCT01994239UNICANCER120
已完成
3 期
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)Atherosclerotic Cardiovascular DiseaseNCT04929249Novartis Pharmaceuticals450