Condition category
Infections and Infestations
Date applied
05/09/2014
Date assigned
22/09/2014
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Marc Zuckerman

ORCID ID

Contact details

Division of Gastroenterology
Texas Tech University Health Sciences Center
4800 Alberta Avenue
El Paso
79905
United States of America

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 Fisher’s 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

Sponsor information

Organisation

Texas Tech University Health Sciences Center (USA)

Sponsor details

4800 Alberta Avenue
El Paso
79905
United States of America

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes