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gblyth
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Quote gblyth Replybullet Topic: The UK National HALO Patient Registry
    Posted: 18 Nov 2008 at 2:08pm

Many patients are becoming more and more aware of the new HALO treatment for Barrett’s oesophagus. It is now possible to have the treatment provided under the auspicies of the UK National HALO Patient Regisitry organised by Dr Laurence Lovat, Consultant Gastroenterologist & Senior Lecturer in Laser Medicine (the chief investigator) at the National Medical Laser Centre at University College Hospital in London.  

This study has been reviewed by UCLH A Research Ethics Committee (NRES Number 08/H0714/27). Eligible patients may therefore be able to partake in this research under the NHS.

Details can be seen below or you may visit the following website:

 
The UK National HALO Patient Registry
We are investigating the use of HALO radiofrequency ablation for patients with Barrett’s oesophagus and early precancerous changes.  Trials in the USA and Europe have suggested that this treatment is safe and effective in Barrett’s oesophagus. The UK based National Institute for Health and Clinical Excellence has looked at the results of these studies and has concluded that we do not have enough information yet to be certain about long term benefits. They have therefore advised that patients in the UK should be treated within a research setting.
 
This study involves a growing number of hospitals around the UK. All hospitals have experienced consultants, specially trained in this technique carrying out the procedure. Eligible patients are invited to take part in the study.
 
 
The HALO treatment
HALO treatment is applied during an endoscopy procedure (a camera test of the gullet) to destroy the abnormal Barrett’s oesophagus lining. The lining which regrows is usually normal. There are two different types of HALO device. The HALO 360 device treats the entire wall of the gullet. The HALO 90 device is similar, but treats a smaller area. We usually treat patients with the HALO 360 device initially and if, at the next endoscopy, there is any abnormal Barrett’s oesophagus lining left, we retreat with either the HALO 360 or HALO 90 device, depending on how big the area needing treatment is.
 
 
What will happen to me if I take part?
i) Initial Visit
You will be interviewed by your study doctor or the study coordinator to see if you are eligible and willing to take part in the study. We generally only treat patients who we think are at moderate or high risk of developing cancer.  Some patients may require an additional endoscopy prior to having the treatment to confirm the diagnosis or extent of Barrett’s oesophagus and to check if there are changes in the cells to suggest that this patient is at moderate or high risk of developing cancer. 
 
ii)The treatment
HALO ablation is a day case procedure in endoscopy. Before your treatment, you should be taking your usual medication for blocking the production of stomach acid, such as omeprazole.  While you lie on your left side on a table, you will have a sedative injected into a vein in your arm or hand to make you sleepy.  A small flexible tube with a light and camera at the end (the endoscope) will then be passed through your mouth and into your gullet. You will then have HALO ablation treatment. Treatment time is usually around 30-45 minutes. You should remember very little about the treatment as you will be sleepy throughout.
 
iii) Follow-up visits
You will have an endoscopy with repeat HALO ablation of Barrett’s oesophagus every three months for up to 1 year, until there is no visual evidence of Barrett’s oesophagus remaining.  Once there is no visual evidence of Barrett’s oesophagus, you will have an endoscopy with a biopsy to confirm that the Barrett’s oesophagus is no longer present on a microscopic level.  If these biopsies are normal, you will continue “standard of care” endoscopy with biopsy for surveillance every 2-3 years to continue to watch for new Barrett’s oesophagus to form.  Should any new Barrett’s oesophagus develop, you may receive additional ablation procedures. 
 
What are the side effects of any treatment received when taking part?
There is a low risk of a narrowing of the gullet caused by the procedure (<1%). If this were to occur you may require stretching of this narrowing, which is the standard treatment. Some patients may experience chest discomfort and a feeling of sickness after the procedure which can last up to 2 weeks, but usually resolves after 2-4 days. More serious complications are very rare.
 
What if relevant new information becomes available?
 
Sometimes during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, we will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw, we will make arrangements for your care to continue. If you decide to continue in the study, you will be asked to sign an updated consent form. Also, on receiving any information, we might consider it to be in your best interest to withdraw from the study. We will explain the reasons and arrange for your care to continue.Any information which is collected about you during the course of the research will be kept strictly confidential, although we will inform your GP and any other doctors who are treating you that you are taking part in this trial.
 
What will happen to the results of the research study?
We aim to publish the results of this trial in a medical journal within 3 years of completing it. If you would like to know about publications based on this work, please telephone Sally Thorpe at the number at the bottom of this information sheet.
 
Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed by UCLH A Research Ethics Committee (NRES Number 08/H0714/27).
 

Who is organising the research? 
This research study is being organised by Dr Laurence Lovat, Consultant Gastroenterologist & Senior Lecturer in Laser Medicine (the chief investigator) at the National Medical Laser Centre at University College Hospital in London. 
 
How do I take part in the Study?
There are quite a few hospitals around the UK participating in this study. You will need to get a formal referral from your GP or the consultant who is looking after your Barrett’s oesophagus to one of these centres. You may take this information to your doctor and ask them to make a referral for assessment.
 
For information on the doctors currently taking part in the UK National HALO registry, please visit the following link
 
 


Edited by gblyth - 18 Nov 2008 at 8:01pm
I would like to declare that I am a director of SynMed Limited the company that distributes the Halo Treatment from Barrx Medical in the UK.

Geoffrey Blyth




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