EVL Plus Drug to Prevent Variceal Rebleeding
Information source: National Science Council, Taiwan
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bleeding
Intervention: band ligation (Procedure)
Phase: Phase 4
Sponsored by: National Science Council, Taiwan
Official(s) and/or principal investigator(s):
Gin Ho Lo, Principal Investigator, Affiliation: Kaohsiung Veterans General Hospital.
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
Official title: A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: rebleeding rate
Secondary outcome: complications
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.
Minimum age: 20 Years.
Maximum age: 75 Years.
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.
1. association with hepatocellular carcinoma or other malignancy,
2. association with cerebral vascular accident, uremia, sepsis or other debilitating
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.
Locations and Contacts
Gin-Ho Lo, Kaohsiung 813, Taiwan
Starting date: July 2001
Ending date: March 2005
Last updated: September 14, 2006