Condition category
Circulatory System
Date applied
06/06/2016
Date assigned
14/06/2016
Last edited
13/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University College London

Alternative name(s)

UCL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes