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EVL Plus Drug to Prevent Variceal Rebleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371943
Recruitment Status : Terminated
First Posted : September 4, 2006
Last Update Posted : September 15, 2006
Information provided by:
National Science Council, Taiwan

Brief Summary:
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved.

Condition or disease Intervention/treatment Phase
Bleeding Procedure: band ligation Phase 4

Detailed Description:
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 well documented to be effective in reducing variceal rebleeding (4-5). The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6). Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8). It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding. This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Study Start Date : July 2001
Study Completion Date : March 2005

Primary Outcome Measures :
  1. rebleeding rate

Secondary Outcome Measures :
  1. complications

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371943

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Gin-Ho Lo
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
National Science Council, Taiwan
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Principal Investigator: Gin Ho Lo Kaohsiung Veterans General Hospital.

Layout table for additonal information Identifier: NCT00371943    
Other Study ID Numbers: EVL
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006
Keywords provided by National Science Council, Taiwan:
variceal bleeding,band ligation, beta-blocker
had history of esophageal variceal bleeding
Additional relevant MeSH terms:
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Pathologic Processes