Plain English Summary
Background and study aims
Gastric antral vascular ectasia (GAVE), also known as watermelon stomach, is a rare condition in which the lining of the stomach bleeds, giving it the characteristic stripes of a watermelon. The exact cause is unknown, however it is associated with the dilation (widening) of the small blood vessels in the last part of the stomach (antrum), which lead to bleeding. This often causes severe anaemia (low red blood cell count or iron levels), which requires treatment with iron supplements or blood transfusions. Radiofrequency ablation (RFA) is a procedure in which the affected tissue (in this case, the dilated blood vessels) are destroyed using heat. The procedure is guided by an endoscope (camera on the end of a thin, flexible tube that is passed into the stomach via the mouth), and targets the affected blood vessels at the bottom of the stomach. The aim of this study is to test the effectiveness of the endoscopic RFA procedure in the treatment of GAVE.
Who can participate?
Adult patients with GAVE that has led to anaemia, who are undergoing endoscopic RFA treatment.
What does the study involve?
All participants undergo RFA treatment for their GAVE. Immediately before the treatment and six months later, participants complete a questionnaire about their quality of life. Six-eight weeks after the RFA treatment, part of standard care given involves a follow up endoscopy to assess how well the treatment has worked. The results of this are recorded by the investigators. Over the six months after treatment, the participant’s medical notes are reviewed in order to record the amount of blood transfusions they have had as well as their red blood cell count (sign of anaemia).
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
University College Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2015 to March 2018
Who is funding the study?
University College London (UK)
Who is the main contact?
Dr Rehan Haidry
Trial website
Contact information
Type
Public
Primary contact
Dr Rehan Haidry
ORCID ID
http://orcid.org/0000-0002-4660-4382
Contact details
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
RadioFrequency Ablation for Gastric Antral Vascular Ectasia
Acronym
RFA for GAVE
Study hypothesis
The aim of this study is to investigate the effectiveness of radiofrequency ablation (RFA) for the treatment of gastric antral vascular ectasia (GAVE).
Ethics approval
NRES Committee London - Central, 03/02/2016, ref: 16/LO/0149
Study design
Longitudinal case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Gastric antral vascular ectasia (GAVE)
Intervention
All patients receive radiofrequency ablation (RFA) for the treatment of gastric antral vascular ectasia (GAVE) coupled with standard care. The usual care pathway involves regular blood tests to assess the requirement for blood transfusions or iron supplementation both before and after any endoscopic intervention. Following a treatment with RFA, a repeat endoscopy is performed 6-8 weeks later to assess a response to treatment and apply further therapy should it be indicated. Should it be necessary to repeat RFA then a further endoscopy 6-8 weeks later may also be performed.
In this study, immediately before and six months after undergoing RFA, participants complete a quality of life questionnaire. In addition, over the six months following treatment, transfusion requirements and haemoglobin concentrations of patients and data from any follow up endoscopies is collected through medical note review in order to assess the effectiveness of the treatment pathway.
Intervention type
Phase
Drug names
Primary outcome measure
1. Quality of life is measured using the Functional Assessment of Chronic Illness Therapy - fatigue scale (FACIT-F) questionnaire at baseline (pre-RFA) and 6 months post-RFA
2. Number of red blood cell (RBC) packs transfused (transfusion requirement), parenteral iron requirements and haemoglobin concentrations (g/dL) are measured by reviewing patient notes and blood tests at baseline (pre-RFA) and 6 months post-RFA
Secondary outcome measures
1. Number of endoscopy treatment sessions are measured by reviewing patient notes at baseline (pre-RFA) and 6 months post-RFA
2. Percentage surface regression in macroscopically evident GAVE is measured during endoscopy at any follow up endoscopy in the 6 months post-treatment
Overall trial start date
01/09/2015
Overall trial end date
01/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Existing diagnosis of GAVE that has resulted in anaemia requiring either intravenous iron replacement or blood transfusion
2. Undergoing endoscopic treatment with RFA
3. Aged 18 years and over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Active malignancy
2. Anaemia due to other cause such as coeliac disease, small bowel pathology or haematological disease
3. Pregnancy
Recruitment start date
01/09/2015
Recruitment end date
01/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College Hospital
235 Euston Road
Fitzrovia, London
London
NW1 2BU
United Kingdom
Funders
Funder type
University/education
Funder name
University College London
Alternative name(s)
UCL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a Gastroenterology peer reviewed related journal.
Intention to publish date
01/09/2018
Participant level data
Available on request
Basic results (scientific)
Publication list