CClinicalTrials.gg
TerminatedNCT00371943Updated Sep 15, 2006

EVL Plus Drug to Prevent Variceal Rebleeding

A Phase 4 interventional study of band ligation in Bleeding, sponsored by National Science Council, Taiwan. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-09-15.

Sponsored by National Science Council, Taiwan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bleeding

Browse trials for

Keywords

  • variceal bleeding,band ligation, beta-blocker
  • had history of esophageal variceal bleeding
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

National Science Council, Taiwan is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants

Interventions

  • Procedureband ligation
06

What researchers measure

Primary outcomes

  1. rebleeding rate

Secondary outcomes

  1. complications

07

Study locations

1 site
  • Gin-Ho Lo
    Kaohsiung, 813, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00371943
Lead sponsor
National Science Council, Taiwan
First posted
Sep 4, 2006
Start date
Jul 2001
Completion
Mar 2005
Last update
Sep 15, 2006

Study contacts

Gin Ho Lo
principal investigator · Kaohsiung Veterans General Hospital.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion