NCT00371943

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

September 15, 2006

Status Verified

September 1, 2006

First QC Date

September 1, 2006

Last Update Submit

September 14, 2006

Conditions

Bleeding

Keywords

variceal bleeding,band ligation, beta-blockerhad history of esophageal variceal bleeding

Outcome Measures

Primary Outcomes (1)

  • rebleeding rate

Secondary Outcomes (1)

  • complications

Interventions

band ligationPROCEDURE

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute bleeding from esophageal varices (defined below);
  • the etiology of portal hypertension was cirrhosis; and
  • 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.

You may not qualify if:

  • association with hepatocellular carcinoma or other malignancy,
  • association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
  • had history of gastric variceal bleeding,
  • received beta blocker within one month prior to entry,
  • 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).
  • had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,
  • deep jaundice (serum bilirubin \>10mg/dl),
  • encephalopathy greater than stage II,
  • failure in control of index variceal bleeding,
  • death within 24 hours of admission, or
  • refused to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gin-Ho Lo

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gin Ho Lo

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

July 1, 2001

Study Completion

March 1, 2005

Last Updated

September 15, 2006

Record last verified: 2006-09

Locations

TW(1)