Patient Resources

Frequently Asked Questions

While not an exhaustive list, we certainly hope that some of these will help address many of your thoughts and concerns about your Barrett's esophagus and radiofrequency ablation.

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How much will it hurt during and after the RFA procedure?

You will be sedated during the procedure. The type of sedation will be based on your general medical condition. The vast majority of people do not report pain during the procedure. In clinical trials, most patients have reported no or minimal discomfort during the procedure.1-3

Patients may experience chest discomfort, sore throat and/or painful or difficult swallowing after the procedure, which are managed with medications provided by the physician. In clinical trials, these symptoms typically resolved within 3-4 days.1-3 In a randomized control trial evaluating RFA in 127 patients, the average chest discomfort score (as reported by the patients) was 23 out of 100 on the first day after the procedure. By day eight, the average chest discomfort score was zero in these patients.4

Your doctor can best advise you as to what to expect regarding pain and discomfort during and after the procedure. It is important to follow your doctor’s post-procedure instructions and take prescribed medications as directed to aid healing and minimize discomfort.

How do I prepare for the procedure?

Consult your doctor’s office for specific pre-procedure instructions.

Prior to the RFA procedure, your doctor may alter the type or dosing of certain medications, based on your individual needs. These include:

Acid suppression medications-

It is important that your acid reflux is well-controlled before, during, and after the RFA procedure. Therefore, your doctor may increase or change these medications (such as proton pump inhibitors or PPIs) to achieve the best possible acid control 1-2 weeks before the RFA procedure.

Platelet-inhibiting, anti-coagulant, or non-steroidal anti-inflammatory medications-

These medications may affect bleeding characteristics and include, but are not limited to: aspirin, clopidogrel, heparin, warfarin, ibuprofen and naproxen.

Preparation the day before the procedure:

Generally, you will be instructed to fast before the RFA procedure. That usually means you should not eat or drink after midnight the night before the procedure. You will need to confirm with your doctor the specific terms of your fast and which of your medications you should or should not continue while fasting.

What and when can I eat after the procedure?

In the Ablation of Intestinal Metaplasia Trial (AIM-II) patients were instructed to maintain a full liquid diet for 24 hours and then advance to soft diet for one week.1,5-7 Consult your doctor for specific post-procedure diet instructions.

What medications will I take before and after the procedure?

Your medication before and after the RFA procedure will be tailored to your individual needs and determined by your doctor.

It is important that your acid reflux is well-controlled before, during, and after the RFA procedure. Your doctor may increase or change your acid suppression medications to achieve the best possible acid control one to two weeks before the RFA procedure. You will likely continue this same acid control regimen for some time after the RFA procedure.

In published clinical trials, patients have been instructed to take some or all of the following types of medications:1,4-7

To minimize acid:

  • Acid suppression medications such as PPIs (as discussed above)

To minimize pain and discomfort:

  • Liquid antacid/lidocaine mixture
  • Liquid acetaminophen with or without codeine, or similar analgesic
  • Liquid sucralfate oral suspension

How long does the RFA procedure take?

The procedure itself is quite short, with published trials reporting average procedure times ranging from 25 to 50 minutes.1,3,4

How long will it take me to recover from the procedure?

RFA is performed as an outpatient procedure. Immediately after the procedure, you will likely spend some time resting in recovery while the sedation medications wear off.

Recovery time is variable in the days after the RFA procedure, with most patients reporting mild discomfort lasting two to four days.1-4 Most patients are able to work and perform their normal daily activities during this time.

Can I continue on my aspirin, clopidogrel, ibuprofen, or warfarin before and after my RFA procedure?

Consult your doctor before your scheduled RFA appointment to determine if you should continue these medications.

Does insurance cover the RFA procedure?

Coverage and individual benefits vary widely among insurance plans and change often.  If you are uncertain about your coverage for the procedure or would like more information, please contact Covidien GI Solutions (formerly BARRX Medical) at reimbursement@barrx.com.

What are my out of pocket costs expected to be?

You may be responsible for a portion of the cost, depending upon your insurance plan.  In order to determine your insurance benefits, you may need to speak with your doctor’s office regarding any expected costs or you can contact your insurance plan directly. 

What complications might occur?

In general, RFA is a very safe procedure. As with all medical procedures, there is a small risk for complications. We recommend you discuss the possible risks and benefits with your doctor before undergoing RFA therapy. Possible complications include, but are not limited to:5,6

  • A narrowing of the esophagus, referred to as a stricture. Strictures can cause difficulty with swallowing and may need to be treated with additional endoscopic procedures.
  • Bleeding which may or may not require treatment.
  • Perforation of the stomach, esophagus, or pharynx which may require surgical repair.
  • Cardiac arrhythmia (abnormal heart rhythm).
  • Infection.
  • Death.

What if I’ve had a hernia repair?

Let your physician know you have had a hernia repair in the past. Peer-reviewed published data indicates RFA can be safely and effectively performed in patients with a history of hernia repair.8-10 Consult your doctor to determine the best management plan for your individual case.

How many treatment sessions will I need and over what time frame?

Published studies report most patients need an average of 2 to 3.5 RFA treatment  sessions to achieve eradication of their Barrett’s.1,3,4,8,10-12 Some people will need more, some less. The medical literature suggests that patients with longer segments of Barrett's tissue may need more treatment sessions than patients with shorter segments.13

RFA treatment sessions are usually performed every two to three months until there is no more visible Barrett’s esophagus. Your doctor will then take biopsy samples of your esophagus, similar to previous surveillance endoscopies you may have had to monitor your Barrett’s esophagus. This is to confirm that your Barrett’s esophagus is gone. Overall, in most people, the RFA treatment course involves 2-3 treatment sessions over the time period of 4 months to one year.

Does RFA treat cancer of the esophagus?

RFA is generally used to treat Barrett’s esophagus, which is the precursor to a type of esophageal cancer called esophageal adenocarcinoma. In some studies, physicians have used endoscopic resection (a tissue removal technique performed during endoscopy) to treat very early forms of esophageal adenocarcinoma, followed by RFA to treat any remaining Barrett's tissue.11,23,24 Consult your doctor to determine the best management plan for your individual case.

What are the eradication rates?

In the peer-reviewed medical literature, published eradication rates of complete treatment courses of radiofrequency ablation of Barrett’s esophagus range from 72%-100%, with many trials reporting eradication rates ≥ 90%.1-4,8-14

What studies have been published on this technology?

There are over 80 peer-reviewed publications describing RFA of Barrett’s esophagus. These include two randomized control trials, cohort studies and patient registries. Published studies have evaluated RFA treatment in all grades of Barrett’s esophagus, including non-dysplastic, low-grade dysplasia, and high-grade dysplasia. See the Management Options - Clinical Results section for more details.

What are the rates of progression of Barrett’s esophagus to cancer before and after ablation therapy?

Barrett's esophagus may progress to more advanced forms of Barrett's esophagus or esophageal adenocarcinoma. The rates of progression of Barrett’s esophagus to esophageal adenocarcinoma vary depending on the severity (or grade) of disease. Possible grades of Barrett's esophagus include: non-dysplastic, low-grade dysplastic and high-grade dysplastic. The grade of a patient's Barrett’s esophagus is determined by evaluation of biopsy specimens taken from the esophagus during an upper endoscopy exam.

The following represent the range of published annual progression rates of Barrett’s esophagus to esophageal adenocarcinoma, based on baseline Barrett’s esophagus grade, in patients who have not undergone ablation therapy:

  • Non-dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 0.12%-0.6% per patient per year 15,16
  • Low-grade dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 0.5% to 3.4% per patient per year 15,17
  • High-grade dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 6.6% to 19% per patient per year 18,4

The following represent published annual progression rates of Barrett’s esophagus to esophageal adenocarcinoma, based on baseline Barrett’s esophagus grade, in patients who have undergone ablation therapy*:

  • Non-dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 0.16% per patient per year 16
  • Low-grade dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 0.16% per patient per year 16
  • High-grade dysplastic Barrett’s esophagus progression to esophageal adenocarcinoma: 1.7% per patient per year 16

*This data represents progression rates to cancer after treatment with different types of ablation, not just RFA.

 

Will I die from Barrett’s esophagus?

A diagnosis of Barrett’s esophagus is significant because it may be a precursor to esophageal adenocarcinoma. Though a relatively uncommon cancer, patients with Barrett’s esophagus have at least a 44 to more than 220 times increased risk of developing esophageal adenocarcinoma per year compared to the general population.15,16,19,20 Barrett’s esophagus may progress to esophageal adenocarcinoma at variable rates, depending on the baseline severity (grade) of Barrett’s esophagus (see What are the rates of progression of Barrett’s esophagus to cancer before and after ablation therapy?).

Depending on the stage at diagnosis, esophageal adenocarcinoma can be lethal. The overall five-year survival rate after a diagnosis of esophageal adenocarcinoma is approximately 17%.19 If you have been diagnosed with either Barrett’s esophagus or esophageal adenocarcinoma, we strongly encourage you to consult with a medical professional who can provide you with a prognosis.

How often does Barrett’s esophagus come back after RFA treatment?

In a recent study evaluating durability of eradication in Barrett’s esophagus patients who had undergone RFA treatment, 92% of patients remained free of Barrett’s at 5 years. Barrett’s esophagus recurred in 8% of the patients. In the patients with recurrent Barrett’s esophagus, the recurrent disease was the same grade as the original (baseline) disease. In other words, there was no disease progression in these patients.21 Another study reported that in patients with more advanced Barrett’s containing dysplasia, at least 85% of patients remained free of dysplasia and at least 75% of patients remained free of all Barrett’s (dysplastic and non-dysplastic) at average follow-up of a little over 3 years.22

It is extremely important to maintain good acid control after RFA treatment. This may be achieved by medications (such as PPIs) or by surgical or endoscopic repair, or a combination of the two. The patients described in the studies above continued on acid suppression medication (mostly PPIs) after RFA to minimize esophageal acid exposure.

Will I still need to undergo endoscopy (EGD) with biopsy surveillance after undergoing RFA therapy?

Currently, most doctors continue to perform endoscopic biopsy surveillance in patients who have undergone RFA. You should discuss the specific terms of your post-RFA endoscopic biopsy surveillance schedule with your doctor. As more long-term RFA data becomes available, endoscopic biopsy surveillance may become less frequent in people who have undergone RFA therapy.

Will I still need to take my acid reflux (PPI) medication after undergoing RFA treatment?

RFA treats Barrett's esophagus, not acid reflux. Therefore, your acid reflux will need to be managed after RFA, either with continued use of acid suppression medications (PPIs), through surgical or endoscopic reinforcement of the valve between your esophagus and stomach, or a combination of the two. You and your doctor will need to decide on the best management strategy based on your individual needs. 

Will I still have reflux after undergoing RFA?

Yes. The RFA procedure does not treat acid reflux. RFA treats Barrett’s esophagus, which is a change in the cells that line the esophagus that occurs as a result of chronic acid reflux. So, RFA treats Barrett’s esophagus, but not its cause. You and your doctor will need to determine the best management for your reflux after undergoing RFA treatment.

Are there support groups?

Yes, there are support groups. You may find the following link helpful:

How can I learn more about Barrett’s esophagus and cancer of the esophagus?

You may find the following links helpful:

How do I find a physician to perform the RFA procedure?

This website includes a physician finder, which helps you find local doctors who are performing RFA therapy. Click on the following link to find a physician performing RFA in your area:

Find a Barrett's physician.

Are there clinical trials I can enroll in?

Currently, there are no active RFA clinical trials that are enrolling patients.

DISCLAIMER: This information is intended only to provide general information and not as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition, contraindications, and possible complications. This treatment is contraindicated in patients who are pregnant, have had prior radiation therapy to the esophagus, esophageal varices at risk for bleeding, or prior Heller myotomy. Possible complications may include: mucosal laceration, perforation of the esophagus requiring surgery, infection, bleeding, and stricture formation requiring dilation. The overall complication rate reported for this procedure is approximately <.02% (data on file).

 

References:

  1. Fleischer DE, Overholt BF, Sharma VK, et al. Endoscopic ablation of Barrett’s esophagus: a multicenter study with 2.5-year follow-up. Gastrointest Endosc 2008; 68:867-76.
  2. Gondrie JJ, Pouw RE, Sondermeijer CM, et al. Stepwise circumferential and focal ablation of Barrett’s esophagus with high-grade dysplasia: results of first prospective series of 11 patients. Endoscopy 2008;40:359-369.
  3. Sharma VK, Kim HJ, Das A, et al. A prospective pilot trial of ablation of Barrett’s esophagus with low-grade dysplasia using stepwise circumferential and focal ablation (HALO system). Endoscopy 2008;40:380-387.
  4. Shaheen NJ, Sharma P, Overholt BF, et al. Radiofrequency ablation in Barrett’s esophagus with dysplasia. N Engl J Med 2009;360:2277-2288.
  5. 717-0016-01 (E) HALO360+ IFU (Instructions for Use).
  6. 717-0026-01 (C) HALO90, HALO90 ULTRA, and HALO60 IFU (Instructions for Use).
  7. Sharma VK, Wang KK, Overholt BF, et al. Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett’s esophagus: 1-year follow-up of 100 patients. Gastrointest Endosc 2007;65:185-195.
  8. dos Santos RS, Bizekis C, Ebright M, et al. Radiofrequency ablation for Barrett's esophagus and low-grade dysplasia in combination with an antireflux procedure: A new paradigm.  J Thorac Cardiovasc Surg 2010;139:713-716.
  9. O'Connell K, Velanovich V. Effects of Nissen fundoplication on endoscopic endoluminal radiofrequency ablation of Barrett's esophagus.  Surg Endosc 2011;25:830-834.

    Shaheen NJ, Kim HP, Bulsiewicz WJ, et al. Prior Fundoplication Does not Improve Safety or Efficacy Outcomes of Radiofrequency Ablation: Results from the U.S. RFA Registry. J Gastrointest Surg 2012 Sep 11. [Epub ahead of print]

  10. Pouw RE, Wirths K, Eisendrath P, et al. Efficacy of radiofrequency ablation combined with endoscopic resection for Barrett’s esophagus with early neoplasia. Clin Gastroenterol Hepatol 2010;8:23-29.
  11. Lyday WD, Corbett FS, Kuperman DA, et al. Radiofrequency ablation of Barrett's esophagus: outcomes of 429 patients from a multicenter community practice registry.  Endoscopy 2010;42:272-278.
  12. Korst RJ, Santana-Joseph S, Rutledge JR, et al. Effect of hiatal hernia size and columnar segment length on the success of radiofrequency ablation for Barrett's esophagus: A single-center, phase II clinical trial. J Thorac Cardiovasc Surg 2011;142:1168-1173.
  13. Zemlyak AY, Pacicco T, Mahmud EM, et al. Radiofrequency ablation offers a reliable surgical modality for the treatment of Barrett's esophagus with a minimal learning curve. Am Surg 2012;78:774-778.
  14. Hvid-Jensen F, Pedersen L, Drewes AM et al. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med 2011;365:1375-83.
  15. Wani S, Puli SR, Shaheen NJ, et al. Esophageal adenocarcinoma in Barrett's esophagus after endoscopic ablative therapy: a meta-analysis and systematic review. Am J Gastroenterol 2009;104:502-13.
  16. Curvers WL, ten Kate FJ, Krishnadath KK, et al. Low-grade dysplasia in Barrett's esophagus: overdiagnosed and underestimated. Am J Gastroenterol 2010;105:1523-30,
  17. Rastogi A, Puli S, El-Serag HB et al. Incidence of esophageal adenocarcinoma in patients with Barrett's esophagus and high-grade dysplasia: a meta-analysis. Gastrointest Endosc 2008;67:394-8.
  18. Howlader N, Noone AM, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2009 (Vintage 2009 Populations), National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2009_pops09/, based on November 2011 SEER data submission, posted to the SEER web site, 2012. http://seer.cancer.gov/statfacts/html/esoph.html. Accessed December 21, 2012.
  19. SEER: Cancer of the Esophagus (Invasive): Percent Distribution and Counts by Histology among Histologically Confirmed Cases, 2005-2009. http://seer.cancer.gov/csr/1975_2009_pops09/browse_csr.php?section=8&page=sect_08_table.22.html. Accessed December 21, 2012.
  20. Fleischer DE, Overholt BF, Sharma VK, et al. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy 2010;42:781-789.
  21. Shaheen NJ, Overholt BF, Sampliner RE, et al. Durability of radiofrequency ablation in Barrett's esophagus with dysplasia. Gastroenterology 2011;141:460-468.
  22. van Vilsteren FG, Pouw RE, Seewald S, et al.  Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial.  Gut 2011;60:765-773.
  23. Bulsiewicz WJ, Kim HP, Dellon ES, et al. Safety and efficacy of endoscopic mucosal therapy with radiofrequency ablation for patients with neoplastic Barrett's esophagus. Clin Gastroenterol Hepatol 2012 Oct 25. [Epub ahead of print].