Prevention of Esophageal Variceal Rebleeding (NCT00863837) | Clinical Trial Compass
UnknownPhase 4
Prevention of Esophageal Variceal Rebleeding
120 participantsStarted 2006-12
Plain-language summary
BACKGROUND: Previous studies showed that the combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
Thus, the investigators designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. The etiology of portal hypertension is cirrhosis.
✓. Age ranges between 18-80 y/o.
✓. Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:
✓. EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.
Exclusion criteria
✕. association with severe systemic illness, such as sepsis, COPD, uremia
✕. association with gastric variceal bleeding
✕. failure in the control of bleeding by emergency EVL
✕. moribund patients, died within 12 hours of enrollment
✕. Uncooperative
✕. Ever received EIS, EVL within one month prior to index bleeding
What they're measuring
1
very early rebleeding
Timeframe: 5 days
Trial details
NCT IDNCT00863837
SponsorNational Science and Technology Council, Taiwan