Status:
COMPLETED
Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Germans Trias i Pujol Hospital
Hospital Universitario Ramon y Cajal
Conditions:
Esophageal Varices
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 shoul...
Detailed Description
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01242280
Start Date
January 1 2010
End Date
June 1 2014
Last Update
February 5 2015
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036