Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
Esophageal Varices, Bleeding, Cirrhosis
About this trial
This is an interventional treatment trial for Esophageal Varices focused on measuring Acute variceal bleeding, Massive bleeding, Liver Cirrhosis, Esophageal tamponade, Esophageal stent
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Self-expandable esophageal stent
Sengstaken-Blakemore tube
The patient will receive a self-expandable esophageal stent (SX-Ella-Danis) without endoscopical guidance but under slight sedation. An immediate X-ray will be done to assess the correct placement of the stent. After a maximum of 7 days, the stent will be removed by using the specifically designed devices.
The esophageal tamponade will be done as described elsewhere. The gastric content will be checked hourly and the correct placement of the tube will be checked by an immediate X-ray. The esophageal balloon will be inflated a maximum of 24 hours.