Risk of bacteremia in banding versus sclerotherapy of esophageal varices

ISRCTN ISRCTN87365879
DOI https://doi.org/10.1186/ISRCTN87365879
Secondary identifying numbers N/A
Submission date
05/09/2014
Registration date
22/09/2014
Last edited
16/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Marc Zuckerman
Scientific

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

Study information

Study designProspective randomized study in single center done before to register retrospective clinical study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective randomized study on the risk of bacteremia in banding versus sclerotherapy of esophageal varices
Study objectivesAfter 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(s)Texas Tech University Health Sciences Center Institutional Review Board, 03/16/1993
Health condition(s) or problem(s) studiedBacteremia in patients with liver disease admitted for UGI bleeding
InterventionAll 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 typeOther
Primary outcome measureBlood 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 measuresContinuous 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 study start date01/07/1995
Completion date01/04/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants94
Total final enrolment94
Key inclusion criteriaPatients 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
Key exclusion criteriaPatients were excluded if they had received any antibiotics in the last 2 weeks before inclusion in the study
Date of first enrolment01/07/1995
Date of final enrolment01/04/1997

Locations

Countries of recruitment

  • United States of America

Study participating centre

Division of Gastroenterology
El Paso
79905
United States of America

Sponsor information

Texas Tech University Health Sciences Center (USA)
University/education

4800 Alberta Avenue
El Paso
79905
United States of America

ROR logo "ROR" https://ror.org/033ztpr93

Funders

Funder type

Other

Investigator initiated and funded (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/05/2016 16/10/2019 Yes No

Editorial Notes

16/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.