Esophageal Stent is More Effective Than Tamponade Controlling Refractory Esophageal Variceal Bleeding: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Combined: bleeding + absence of severe adverse events + survival
研究概览
简要总结
In the last years, important advances have been done in the treatment and prevention of esophageal variceal bleeding. Experts agree that the combination of pharmacological and endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy. Nevertheless, some patients would require different therapies to act as a "bridge" until definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube) represents, up to now, the most widely used temporary "bridge" to TIPS. However, balloon tamponade is associated with a high incidence of serious adverse events. Recently, the use of self-expanding metal stents have been introduced in the treatment of acute variceal bleeding showing a very high hemostatic efficacy with no adverse events. The present study is directed to compare the efficacy free of adverse events and mortality of self-expanding metal stents vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic therapy.
详细描述
BACKGROUND Acute variceal bleeding (AVB) carries a 20% death rate during the acute episode and nearly 50% related-mortality during the first year after the episode. (1). Prognostic factors of AVB include: the severity of bleeding, the degree of liver failure and the development of complications other than bleeding.
Therefore, AVB therapy must: achieve primary hemostasis and prevent and treat both hypovolemia and related complications. After hemodynamic stabilization, upper endoscopy should be done to confirm the diagnosis and start specific therapy, that is to say: 1/ vasoactive drugs (terlipressin or somatostatin); and 2/ endoscopic therapy (variceal banding ligation). These two combined therapies achieve control of AVB in 80% of the cases (2). Nevertheless, in the remaining 20%, the AVB is not controlled requiring balloon-tamponade as a bridge to definitive hemostatic therapies such as TIPS or surgical shunts(3). The Sengstaken-Blakemore tube is the most widely used balloon tamponade. In experienced hands it provides bleeding control rates up to 90%. It should only be used by skilled staff in intensive care facilities because fatal complications may arise in more than 20% of cases. The main complications are: aspiration pneumonia, esophageal rupture, asphyxia due to balloon migration, esophageal ulcers, tongue or nose or lips necrosis, arrythmia and chest pain. These complications are time-related, therefore, balloon tamponade never must remain inflated more than 24h.
Recently, a self-expandable esophageal stent has been introduced as an alternative to esophageal balloon tamponade in AVB (4). Twenty patients with AVB not controlled with combined endoscopic and pharmacological therapy were retrospectively included in the study. The patients received a self-expandable metal esophageal stent (SX-Ella-Danis, Czesc Republic). The stent was placed without complications in all cases achieving a 100% success in the control of AVB. Two to 14 days after, the stents were retired. The authors observed no case of severe stent-related complications and no rebleeding episodes (4).
These data suggest that self-expandable esophageal stent could represent a safe and effective option to temporary treat patients with AVB refractory to medical and endoscopic therapy. In addition, and theoretically, esophageal stent could be associated with a lower incidence of adverse events than balloon tamponade.
EXPECTED RESULTS
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include all patients with cirrhosis admitted to the hospital because an acute esophageal variceal bleeding defined according to Baveno II criteria (5) and who will achieve the following criteria:
- •Failure to control bleeding despite pharmacological (somatostatin 3 or 6 mg/12h iv or terlipressin, 2mg/4h iv) AND endoscopic therapy (esophageal banding ligation preferably or sclerotherapy). Failure to control bleeding was defined, according to Baveno IV criteria (6), as evidence of continuous digestive bleeding and any of the following:
- •Hematemesis (or naso-gastric aspirate > 100 ml of fresh blood) > 2h after the start of combined pharmacological and endoscopic therapy.
- •Decrease in hemoglobin values > 3g vs previous values (without blood transfusion).
- •Massive bleeding. Acute variceal bleeding uncontrolled despite pharmacological therapy started at any moment, with no need of previous endoscopic therapy. Uncontrolled bleeding is defined as an upper digestive bleeding in which no hemodynamic stability (systolic arterial pressure > 70 mmHg and heart rate < 100 bpm) could be achieved.
排除标准
- •Age < 18 years.
- •Esophageal rupture.
- •Esophageal, gastric or upper respiratory tract tumor.
- •Esophageal stenosis.
- •Recent esophageal surgery.
- •Previous esophageal tamponade to treat the index bleed.
- •Big hiatal hernia precluding the correct placement of the esophageal devices.
- •Known hepatocellular carcinoma surpassing Milan criteria.
- •Terminal disease.
- •No written consent to participate in the study.
结局指标
主要结局
Combined: bleeding + absence of severe adverse events + survival
时间窗: 15 days
The primary endpoint combines absence of bleeding + absence of severe adverse events probably related to the study devices + survival during the first 15 days after inclusion in the study or at hospital discharge. Patients to compare are those with liver cirrhosis and acute variceal bleeding (AVB) not controlled with combined pharmacological and endoscopic therapy (see definitions). Those patients will be randomized to receive a self-expandable esophageal stent (SX-Ella-Danis) or balloon tamponade with a Sengstaken-Blakemore tube.
次要结局
- Applicability of definitive hemostatic therapy.(15 days)
- Adverse events(15 days)
- Bleeding(6 months)
- Survival(6 months)
- Analgesia and sedation requirements(15 days)
- Hospital stay(6 months)
- Transfusional requirements(15 days)
研究者
Angels Escorsell
Consultant. Liver Unit
Hospital Clinic of Barcelona