EVL Plus Drug to Prevent Variceal Rebleeding
Information source: National Science Council, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bleeding
Intervention: band ligation (Procedure)
Phase: Phase 4
Status: Terminated
Sponsored by: National Science Council, Taiwan Official(s) and/or principal investigator(s): Gin Ho Lo, Principal Investigator, Affiliation: Kaohsiung Veterans General Hospital.
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.
Clinical Details
Official title: A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: rebleeding rate
Secondary outcome: complications
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Gin-Ho Lo, Kaohsiung 813, Taiwan
Additional Information
Starting date: July 2001
Last updated: September 14, 2006
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