Risk of bacteremia in banding versus sclerotherapy of esophageal varices
ISRCTN | ISRCTN87365879 |
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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
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
Scientific
Division of Gastroenterology
Texas Tech University Health Sciences Center
4800 Alberta Avenue
El Paso
79905
United States of America
Study information
Study design | Prospective randomized study in single center done before to register retrospective clinical study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A prospective randomized study on the risk of bacteremia in banding versus sclerotherapy of esophageal varices |
Study objectives | 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(s) | Texas Tech University Health Sciences Center Institutional Review Board, 03/16/1993 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/07/1995 |
Completion date | 01/04/1997 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 94 |
Total final enrolment | 94 |
Key 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 |
Key exclusion criteria | Patients were excluded if they had received any antibiotics in the last 2 weeks before inclusion in the study |
Date of first enrolment | 01/07/1995 |
Date of final enrolment | 01/04/1997 |
Locations
Countries of recruitment
- United States of America
Study participating centre
79905
United States of America
Sponsor information
University/education
4800 Alberta Avenue
El Paso
79905
United States of America
https://ror.org/033ztpr93 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.