Status:
UNKNOWN
Prevention of Esophageal Variceal Rebleeding
Lead Sponsor:
National Science and Technology Council, Taiwan
Conditions:
Esophageal Variceal Rebleeding
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 hemost...
Detailed Description
Methods of treatment: Group 1: Somatostatin 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours ...
Eligibility Criteria
Inclusion
- 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:
- when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR
- when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
- 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
- Child-Pugh's scores \> 10
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00863837
Start Date
December 1 2006
End Date
December 1 2009
Last Update
March 18 2009
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