Plain English Summary
Background and study aims
Esophageal varices (EV) is a condition where the blood vessels in the esophagus are extremely dilated (widened). Banding is a treatment that uses elastic bands to tie the blood vessels in order to stop bleeding. The other treatment available for this condition is sclerotherapy, where a medicine is injected which will cause the blood vessels to shrink. Esophageal variceal banding may be less likely to cause bacteremia (occurrence of bacteria in the blood) than sclerotherapy. We do not know how frequently bacteremia occurs after banding or sclerotherapy. We conducted this study to compare the frequency of bacteremia after banding and sclerotherapy.
Who can participate?
Patients with liver disease admitted for upper gastrointestinal bleeding or those who came for variceal therapy who have had previous treatment for EV.
What does the study involve?
Those who came as an outpatient for elective sclerotherapy or banding were given their preferred treatment. New patients with upper GI bleeding were checked by endoscopy before any treatment. Those who required treatment were randomly allocated to either undergo either banding or sclerotherapy. Those who did not need treatment were considered as the control group. Blood samples of all patients were analysed at 5 and 30 minutes to check for bacteremia.
What are the possible benefits and risks of participating?
There were no financial benefits of participating in this study. Patients received treatment for esophageal varices. There were no obvious risks.
Where is the study run from?
Thomason General Hospital in El Paso, Texas, USA.
When is the study starting and how long is it expected to run for?
July 1995 to April 1997.
Who is funding the study?
Investigator initiated and funded (USA).
Who is the main contact?
Marc J Zuckerman, MD
Marc.Zuckerman@ttuhsc.edu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective randomized study on the risk of bacteremia in banding versus sclerotherapy of esophageal varices
Acronym
Study hypothesis
After endoscopic variceal ligation (EVL) was introduced, we designed this prospective randomized study to compare the rate of bacteremia after endoscopic esophageal variceal ligation with that of sclerotherapy.
Ethics approval
Texas Tech University Health Sciences Center Institutional Review Board, 03/16/1993
Study design
Prospective randomized study in single center done before to register retrospective clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bacteremia in patients with liver disease admitted for UGI bleeding
Intervention
All patients were screened using endoscopy.
Outpatients for vacricela therapy to undergo: banding or sclerotherapy.
Patients with upper GI bleeding were randomised to:
1. Banding
2. Sclerotherapy
Blood cultures were obtained before, 5 and 30 minutes after endoscopy to check for bacteremia.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Blood cultures were drawn via separate venous punctures of the forearm before endoscopy (BCX1), at 5 minutes (BCX2), and 30 minutes (BCX3) after the endoscopy.
Secondary outcome measures
Continuous data were described using mean and standard deviation (SD) while categorical data were described frequency and proportion. Baseline characteristics were compared among groups. Continuous data were compared using one-way analysis of variance (ANOVA), while categorical data were compared using Fishers exact test.
Overall trial start date
01/07/1995
Overall trial end date
01/04/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with liver disease admitted for UGI bleeding or for outpatient elective variceal therapy with previous EVS and EVL at Thomason General Hospital in El Paso, Texas, from July 1995 to April 1997
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
94
Participant exclusion criteria
Patients were excluded if they had received any antibiotics in the last 2 weeks before inclusion in the study
Recruitment start date
01/07/1995
Recruitment end date
01/04/1997
Locations
Countries of recruitment
United States of America
Trial participating centre
Division of Gastroenterology
El Paso
79905
United States of America
Funders
Funder type
Other
Funder name
Investigator initiated and funded (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary