Radiofrequency Ablation (RFA) – Barrx

One of the newer treatments for Barrett’s esophagus with dysplasia is radiofrequency ablation, also sometimes referred to as Barrx (the name of the company), or Halo (the name of the specific treatment).  Several people have asked questions about Barrx, so here’s some information.

How it works

Halo 360 – Upper endoscopy is performed and the length of the Barrett’s esophagus is measured. A special ‘sizing balloon’ is used to figure out the width of the esophagus where the BE is located.  Once the diameter of the esophagus is known, a special catheter with the ablation balloon on it is passed into the esophagus. There are 3 cm of electrodes on the balloon which are placed in the area of the BE to be treated. When the balloon is inflated, the electrodes touch the wall of the esophagus and energy is released.  The release of the energy creates a shallow burn, which destroys the Barrett’s esophagus without harming the tissue underneath. The treated area is then gently cleaned with a plastic cap on the end of the endoscope to remove any loose tissue. Then the BE is treated a second time with the RFA balloon. 

Circumferential RFA is most often performed with longer BE, particularly when the BE is present on all the walls of the esophagus. 

Halo 90 – A small device that looks like a paddle (about 2 cm by 1 cm in size) is placed on the end of a regular endoscope.  An upper endoscopy is then performed and the paddle is placed on areas of BE that to be treated.  The endoscopist then steps on a pedal, and energy is released, making a shallow burn in the area.  Each area of BE is treated twice, then the mucosa is cleaned with the paddle. The same areas are then treated 2 more times with the Halo90 during the same procedure. 

Halo90 is typically used in patients with small amounts of BE, such as tongues or islands of Barrett’s.  

Complications

Chest discomfort may occur after the procedure. Other possible complications include lacerations of the esophageal mucosa, which is like a shallow tear or cut which may bleed.  Some patients have had difficulty swallowing after the procedure and rarely patients will develop a stricture that needs dilation with a special balloon.  Perforation, or tearing the wall of the esophagus, is a risk, but so far no studies have been published showing a perforation during RFA.

What’s published?

There is alot of interest in ablation of Barrett’s esophagus and several ongoing research studies.  Here are a few of the published studies using RFA in dysplasia:

At Digestive Disease Week 2008, an international gastroenterology meeting, the interim results for a randomized, multicenter, sham-controlled trial of RFA were presented.  All the patients in the study had BE with HGD or LGD.  The patients were randomized (randomly assigned) to either RFA or a sham (fake) RFA.  Halo 360 and Halo 90 were performed to treat the BE and dysplasia. 

At the time of the presentation in May 2008, 127 patients had been treated.  The average number of sessions needed to treat BE with dysplasia was 3.5.  67% of patients with HGD had complete eradication of dysplasia compared to no patients who received the sham treatment.  96% of patients with LGD had complete eradication of dysplasia with RFA.  Looking at complete eradication of the BE, 60% of patients with HGD and 83% of patients with LGD had no BE left after treatment with RFA.  1 patient had a stricture treated with dilation and there were no esophageal perforations.  The study’s expected completion date was summer 2008, so complete results should be available soon. (1) 

A US Multicenter registry study of RFA was published in July 2008, which looked back at the records of 142 patients with BE-HGD at 16 different academic hospitals.  RFA was performed in all the patients using the Halo360.  In this study, patients had 1 to 2 ablation sessions.  2 patients had HGD after ablation.  Of the patients in the study who had follow up biopsies, complete eradication of HGD was seen in 90% of patient.  Complete eradication of all dysplasia (including LGD) was seen in 81%. Complete eradication of all Barrett’s esophagus occurred in 54% of patients.  One patient in the study developed an esophageal stricture (narrowing) which was treated with esophageal dilation. (2)

Another study looked at RFA in patients with early cancer, high grade dysplasia (HGD), or low grade dysplasia (LGD).  44 patients were in the study and 31 patients had endoscopic mucosal resection (EMR) of nodular BE.  The patients then had ablation of the remaining BE using the Halo360 or Halo90 system.  At the end of the study, the BE and dysplasia was completely gone in 98% of the patients (43 of 44).  Follow up at 21 months showed no recurrence of dysplasia in the patients. (3)

Who Should Consider RFA?

Most of the research done with RFA has been targeted to patients with Barrett’s esophagus and dysplasia. The response to treatment is very good in most of the studies, and is a reasonable option to consider for treatment.  For patients without dysplasia, the use of RFA is not as clear, which will be addressed in a separate post. 

Here are the references for the 3 studies discussed above:

  1. Shaheen NJ, Sharma P, Overholt BF, et al.  A randomized, multicenter, sham-controlled trial of radiofrequency ablation for subjects with Barrett’s esophagus containing dysplasia: interim results of the AIM dysplasia trial.  Gastroenterology, Volume 134, Issue 4, Supplement 1, April 2008, Pages A-37
  2. Ganz RA, Overholt BF, Sharma VK, et al.  Circumferential ablation of Barrett’s esophagus, that contains high-grade dysplasia: a U.S. multicenter registry. Gastrointestinal Endoscopy 2008, vol 68(1), pp 35-40. 
  3. Pouw RE, Gondrie JJ, et al. Eradication of Barrett’s esophagus with early neoplasia by radiofrequency ablation, with or without endoscopic resection. J Gastrointest Surg 2008, vol 12, pp 1627-37.

33 thoughts to “Radiofrequency Ablation (RFA) – Barrx”

  1. What is your opinion of Cryoablation and have there been any new studies published recently. A number of people on the discussion seem to be narrowing things down to having either Barrx or Cryo.

  2. Dr. Dunbar (I presume),

    For patients with BE but with no LGD, HGD, or cancer, is RFA an appropriate treatment? Especially considering that patients with this type of BE have a 1.4% yearly chance of developing HGD or cancer? Is RFA an FDA approved procedure for this condition?

    Has this topic been addressed in a separate post as you have suggested above?

    I look forward to your response.

  3. JT – There’s alot of interest in both cryoablation and Barrx. There are no studies (yet) comparing the 2 procedures. At this point in time, there are more published studies about Barrx.

  4. E Buckley – Excellent question with no easy answer. There is (now) a long post about this topic. I checked the FDA website for a description of the approval given. The Halo 360 and Halo 90 are approved for treatment of bleeding and nonbleeding lesions of the GI tract. Barrett’s esophagus is specifically listed, but dysplasia is not mentioned. If you’re interested in reading more, the FDA approval documents (called a 510K) are available to the public for viewing. I found them by searching ‘Barrx’ on the FDA website (www.fda.gov)

  5. Please tell me:

    What are the statistics for squamous overgrowth resulting from RFA for BE with dysplasia and with no dysplasia?

    Although the HALO 90 and HALO 360 are now FDA approved, are they still being tested? Is RFA still considered experimental?

  6. I recently read that a person had RFA in 2008 using the HALO 90 to ablate a 1cm spot of BE with no dysplasia, near the LS, immediately developed a severe stricture requiring 8 dilations in 8 months, accompanied by long term severe esophageal spasms. What would cause such a severe stricture, and how often does this type of problem occur?

    Thank you.

  7. Dear AL Rion –

    Thanks for your comments. Squamous overgrowth of BE has been a concern for years with several fo the ablative therapies for Barrett’s. I’ll address it in a separate post.

    The HALO 90 and 360 are FDA approved for sale and use, but there are still several ongoing studies. I also put this in a separate post because my answer in this reply was getting pretty long.

    And the stricture issue – Strictures have been an issues with some other ablative therapies, such as PDT and very large EMRs. Most of the reports of strictures in the HALO studies I’ve seen have been reported as ‘mild’ – resolving with 1 dilation. I haven’t seen reports of severe strictures published yet, but this doesn’t mean that it can’t happen, so I’ll keep searching the medical literature.

    Strictures are caused by scar tissue – sometimes this is due to years of acid reflux (a peptic stricture), or surgery (esophagectomy), or from ablation (mainly reported with PDT, some with RFA). Treatment is usually with esophageal dilation, which is done using a balloon or tapered rubber tubes that are placed through the stricture. The case you describe sounds like a pretty severe stricture, but hopefully will improve. Occasionally, a temporary esophageal stent can be used to help stretch a stricture and rarely patients will have surgery to repair a stricture.

  8. Is it possible for someone with Barretts Esophagus to have Barrx performed
    if he is “indefinite for dysplagia?

  9. I would be careful in delivering this treatment, as my mother(aged 62) was absolutely scalded, and unable to eat for 3 weeks post treatment. She was treated, suffered for 3 weeks in immense pain with 3rd degree burns in esophogus, and became weaker day by day. At her breaking point (D+3weeks), she was admitted to the hospital for 5 days, with IVs delivering 800 cals per day and initially pumped with 7 liters of fluid to reinvigorate her constitution from dehydration and general malnutrition. I would consider cryotherapy for patients with BE. Do not become a lab rat under this procedure, as it is extremely painful and does much damage to the already delicate tissue suffering from BE.

  10. I had the Barrx procedure 10 days ago on June 10 and I am still in pain – discomfort as I swallow food and at rest. Does anyone know how long this discomfort continues and if this is normal – there has to be a healing period, but for how long?

  11. Dear Martha – Barrx for patients ‘indefinite for dysplasia’ falls into the category of RFA for nodysplastic Barrett’s esophagus. There is a separate post on this topic on our blog at http://apps.pathology.jhu.edu/blogs/barretts/?p=33. Many times, ‘indefinite for dysplasia’ is used when there is inflammation and irritation in the esophagus that makes it hard to tell whether dysplasia is really there or not. Many GI doctors will put a patient with indefinite dysplasia on acid suppression therapy (a proton pump inhibitor) and repeat the EGD later. K Dunbar, MD

  12. Dear John – I haven’t seen many reports of patients having pain and dehydration like your mother has had. I hope she is feeling better and back to eating! There are alot of studies of RFA and cryotherapy being done and they all have a safety component and track complications. Hopefully this will give us more information for patients in the future. K Dunbar, MD

  13. Dear Jim – I hope you start feeling better! You should talk with your GI physician who did your procedure to let him/her know that you’re still having pain. As far as how long the discomfort lasts, most patients who have circumferential (balloon) ablation feel better in a few days. Focal ablation (the little paddle) seems to cause less discomfort. In one recently published study (by Shaheen, NEJM, 2009), patients who had RFA had a pain score of 2 out of 10 (range 0 to 5) on day 1. By day 8, the patients had a pain score of 0 out of 10.

  14. I have been diagnosis BE in July 2009. There was no cancer and no dysplagia found, should I get a 2nd opinon or go ahead with the treatment of RFA ?

  15. Only you can decide whether the small but real very risk of complications with RFA is worth it for you. You have read above about the complications others have experienced. If you do not have dysplasia your risk of cancer is low. You may want to get a second opinion since you sound hesitant to initiate RFA. Many gastroenterologists do not currently suggest RFA for NONdysplastic Barrett’s despite the enthusiasm others have expressed for it. If you decide to have it, choose a center that has experience with it.

    E. Montgomery, MD

  16. Most people do not progress to dysplasia. People who have side effects with RFA are few but probably more than the percentage of people with Barrett’s esophagus who would progress to have dysplasia. Because of this, some gastroenterologists are reluctant to offer RFA to people who do not have dysplasia. However, some of the doctors who participated in the recently published RFA study now advocate RFA for all people with Barrett’s eosphagus, even if they do not have dysplasia. In the large study of people who had RFA for DYSPLASIA in Barrett’s that Dr. Dunbar mentioned above, 6% had strictures from the RFA. This means their esophagus became scarred, which can cause trouble swallowing and pain. The study I am referring to can be read by anyone. It is published in The New England Journal of Medicine in 2009 in volume 360 (the May 28th issue), pages 2277-2288.
    E. Montgomery MD

  17. I have been on many many sites and have really only read good things about ablation before this site. The last post talks about risk of dysplasia. Is this risk low because of the age people are when diagnosed? I was diagnosed last week with no dysplasia. I am 29 years old, female. I’m so confused… I keep multiplying the .5% in my head til 70 and that makes the percentage too high for me I think. What do you recommend for younger people?

  18. The risk of dysplasia is low because it is low. In the united states there are about 16,000 new cases of esophagus cancer diagnosed each year. Compare this with colon cancer; there are about 150,000 new cases each year. There are far more new cases of lung and prostate cancer. The overall risk for any one person with Barrett’s esophagus is very low – there are lots and lots of people with Barrett’s esophagus – in a large Swedish study, about two out of 100 people had it and in one US Veteran’s (VA) hospital study, about one in 4 people had it. You SHOULD be followed if you have Barrett’s esophagus as you are armed with the knowledge that you are in a higher risk group than most people, but your overall risk is still low. If you are heavy, reduce your weight and if you drink a lot of alcohol or smoke, reduce those things. If there are certain foods that set off heartburn for you, reduce your intake of those foods.
    E. Montgomery, MD

  19. I have had GERD for 25 years. I was diagnosed with BE in 1997. I have had biopsies every two years since diagnosis until I progressed to Low Grade Dysplacia. Then I went to every 6 months and saw reversal. I went back to annual biopsie and after some years began progression to LGD then HGD. When I was told that I had HGD I was advised that the “Gold Standard Treatment is removal of the diseased portion of the Esophagus.” I did research on the esophagectomy and the Radio Frequency Ablation procedure. All available on the internet. I found people who have had the treatments both surgical and endoscopic. My wife and I decided that although the RFA does not have the Longitudinal results the short term studies are showing wonderful results. I want the best result with the least risk . So I decided and I have had the Barxx Halo 360 which I found very uncomfortable. I then three months later had the Barxx Halo90 for Islands of BE which remained. After the second treatment the Dr Prescribed Carfatate to coat and protect the throat and that made the post procedure much more comfortable. I must admit I do not like discomfort but after the Having the Halo 360 I had a worse time with the pain meds than I did with the pain. I simply used liquid tylenol untill I could swallow tylenol and was able to manage well with these over the counter measures. I just had my third quarterly Biopsy and after all this time there is only one spot where the BE has returned and has progressed to LGD. I will have another biopsy in three months and will make a decision with my Dr to either repeat the Barxx Halo 90, or consider further the surgery. I encourage you all to do the research you can on the internet and speak with your Doctor so you can make informed decisions. It is your life and it is your decission do not give away your right to choose your treatment. Anyone in Massachusetts Lahey Clinic has a high volume GI department and endorse them for their work Dr Joyce is a specialist in Endoscopic malignacy treatments. Further I want you to know that I lift you all up in my prayers. Researcher, patient, practitioner alike. I ask if you are inclined to mention me in your prayers.

  20. I was diagnosed with Barrett’s in early Sept. I am the same Lisa as 2 posts up from this one. JH confirmed diagnosis and I was ready to go to TN to have it ablated. I was talked into getting a second opinion. Second endoscopy results came back NO barrett’s. Those slides are being sent to JH to compare/confirm. Everyone – get second opinions…!

  21. My brother was diagnosed with early stage adenocarcinoma (T1N0) stemming from Barretts back in July 2009. His doctors said that the preferred treatment was surgery and sent him to a surgeon who recommended an esophagectomy (THE). Since then, someone at the the American Cancer Society recommended that he investigate BARRX ablation and that it had a high success rate with early stage esophageal cancer. So far, I have not been able to find any studies on using this treatment for early stage esophageal cancer. They mainly focus on the pre-cancer stages. Can someone point me to any studies done on using this treatment for early stage cancer? Also, any advice would be appreciated.

  22. Dear Cheryl, There is not a trial of RFA in early carcinomas BUT there are published data on using photodynamic therapy and endoscopic mucosal resection for early Barrett’s cancers and comparing it to surgery and the results were very good. A recent study was at the Mayo clinic. We offer similar treatment here at Johns Hopkins and have good results as well. I do not know where your brother lives but if he is close to here or Mayo Clinic he could ask for opinions. The reference for this study:

    Prasad GA, Wu TT, Wigle DA, Buttar NS, Wongkeesong LM, Dunagan KT, Lutzke LS, Borkenhagen LS, Wang KK. Endoscopic and surgical treatment of mucosal (T1a) esophageal adenocarcinoma in Barrett’s esophagus. Gastroenterology. 2009 Sep;137(3):815-23.

    Elizabeth Montgomery, MD

  23. I need alittle help. I had a EGD done and one doctor said I had barrett’s and another doctor said I did not. My esophageal biopsy read the following:
    A- Benign Squamous mucosa
    B- Benign Gastric type mucosa
    C- Negative for Specialized mucosal eqithelium
    D- Negative for Dysplasia
    E- Mild chronic inflammation
    Does this mean I have barrett’s or I do not ?

  24. Scott,
    It may be worth having another GI pathologist look at your slides. From what you wrote, parts A, B, C, and E don’t sound like Barrett’s. Part D may be, because ‘negative for dysplasia’ is typically something used to describe Barrett’s tissue. But usually there is something else with it stating that Barrett’s esophagus or specialized intestinal metaplasia is present.

  25. This is the same Scott from above, the doctor that said I had Barretts, said it because I had gastric type cells. I went and got a 2nd opinion and was scope for the 2nd time and the other doctor said I did not have Barretts. By having gastric type cells, what are the risk of getting Barretts ?

  26. I had the HALO 360 treatment yesterday. It was painless & I have no discomfort at all. My Dr. came from the Mayo clinic and was experienced in the procedure. Although I only had a small segment of BE with no dysplasia, who wants to have a condition that can turn deadly? So I decided to have the procedure done. I will go back in 2 months for another endoscopy to veryify if the BE is gone. At that time my Dr. may use the HALO 90 to touch up if needed. Very happy with the procedure & glad I did it.

    Michael

  27. I’ve been diagnosed with HGD and I think I’ve decided to go with the RFA instead of surgery. My doctor has only done 6 RFAs in the past year. Is that frequent enough to be highly competent with the procedure or should I seek another facility. The hospital is in Nashville and highly regarded.

  28. Be very careful before you undergo this procedure. There are lots of articles stating how seemingly safe the procedure is, and who wants to wait and see if their Barretts progresses to cancer. I had the first treatment in October. I was uncomfortable for a few day, but not overly concerned, just a bit more trouble lying down and sleeping. I went in to have the second one. I was informed they couldn’t continue the treatment. The tissue previously treated had not healed, but ulcerated. Biopsies were taken and I am being reffered to a surgeon. I’d love to know why Barrx Corp. is not giving proper warnings on their brochure.

  29. I have been diagnosed with HGD. This comes after a history of Barrets, Gerd & Reflux. I also have a hiatas hernia. About 6-7 years ago I had a Nissen Fundalacation (spelling?) to keep my stomach attached to my esophogus which has now failed and is causing more problems. I now have trouble keeping food in my system.I vomit after eating fairly often. Now my endo doctor advises Barrx, and once that heals to redo the Nissen and repair the hernia. I have also spoken to a surgical specialist (who is on the other side of the country) who feels that this makes little sense as all of this can be taken care of with one surgery. He feels why do the Barrx and then have surgery? Makes sense to me, but I’d like to know what others think. Also, if the reflux and Gerd are not taken care of before the Barrx, won’t that affect the recuperation and cause more pain.

  30. I have been diagnosed with Barretts with precancer of the esophagus I have had the Barrx Halo twice and will be having a 3rd on April 1st. I also have a hiatal hernia which my DR overlooks everytime and says after we have done the Barrx Halo he will take a look at the hernia.. why cant he do it the same time? I tell you why More money each time he does the halo they charge the hospital bills the insurance 10k (which procedure takes only30 mins) so means more money in their pockets. The last time I had this was done was 2 months ago the pain was worse and I ran fever that night. All the Dr’s are after is more money.

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