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Search / Trial NCT00371943

EVL Plus Drug to Prevent Variceal Rebleeding

Launched by NATIONAL SCIENCE AND TECHNOLOGY COUNCIL, TAIWAN · Sep 1, 2006

Trial Information

Current as of July 24, 2025

Terminated

Keywords

Variceal Bleeding,Band Ligation, Beta Blocker Had History Of Esophageal Variceal Bleeding

ClinConnect Summary

Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality (1). Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding. In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3). On the other hand, nonselective beta blockers have been...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Acute bleeding from esophageal varices (defined below);
  • 2. the etiology of portal hypertension was cirrhosis; and
  • 3. age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, 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.
  • Exclusion Criteria:
  • 1. association with hepatocellular carcinoma or other malignancy,
  • 2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
  • 3. had history of gastric variceal bleeding,
  • 4. received beta blocker within one month prior to entry,
  • 5. had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate \<55/min) or arterial hypotension (systolic blood pressure\<90 mmHg).
  • 6. had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,
  • 7. deep jaundice (serum bilirubin \>10mg/dl),
  • 8. encephalopathy greater than stage II,
  • 9. failure in control of index variceal bleeding,
  • 10. death within 24 hours of admission, or
  • 11. refused to participate in the trial.

About National Science And Technology Council, Taiwan

The National Science and Technology Council (NSTC) of Taiwan is a pivotal governmental body dedicated to advancing scientific research and technological innovation within the country. As a sponsor of clinical trials, the NSTC plays a critical role in facilitating and funding research initiatives that aim to enhance public health and medical advancements. By fostering collaboration between academia, industry, and healthcare institutions, the NSTC aims to translate scientific discoveries into practical applications that benefit society. Through its commitment to rigorous scientific standards and ethical practices, the NSTC ensures that clinical trials conducted under its auspices contribute to the global body of medical knowledge while prioritizing patient safety and efficacy.

Locations

Kaohsiung, , Taiwan

Patients applied

0 patients applied

Trial Officials

Gin Ho Lo

Principal Investigator

Kaohsiung Veterans General Hospital.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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