Halo 360

The Halo 360 is a balloon catheter specially made to treat Barrett’s esophagus using a form of energy known as radiofrequency. Barrett’s epithelium in the esophagus can be "ablated" or destroyed with minimal injury to surrounding structures using the Halo 360 balloon device. The Halo 360 balloon is 3cm in length and provides circumferential( 360 degrees) of ablation.  The procedure is performed during an upper endoscopy and usually takes around 25 minutes to adequately remove all segments of Barrett’s. 

Halo 90

Advantages

The advantages of radiofrequency ablation are its ease of use, effectiveness in removing Barrett’s, and safety profile. There are several studies underway throughout US and Europe that continue to demonstrate the utility of this procedure. Although, not yet proven, it is hoped that removing Barrett’s esophagus in early stages will lead to a reduced risk of esophageal cancer. Reviews of the procedure’s effectiveness in removing Barrett’s in early and advanced stages have been very good. Also, there has been only a few reports of "buried glands" (areas of untreated Barrett’s underneath normal appearing mucosa) following a successful ablation procedure.

Disadvantages:

This is a new procedure. There are no longterm studies available to prove that removing the Barrett’s esophagus will result in a decrease in esophageal cancer. It is not known if Barrett’s may re-occur after a successful ablation. There is also a small risk of complications resulting from the procedure itself.

Endoscopic Ablation Protocol

Prior to procedure

Talk to the scheduling nurse about any special issues, such as blood thinners or diabetic medications. You should be off coumadin, plavix, and aspirin for five days before and after the procedure to prevent bleeding complications. The day before the procedure, you will have nothing to eat past midnight. On the morning of your procedure nothing to eat or drink. After the procedure you are allowed liquids only for the day.  You will need a driver to take you home after the procedure.

Halo 360/Halo 90 procedures

Endoscopic ablation is performed as part of an upper endoscopy. During the procedure you will be asleep or heavily sedated. The endoscope is advanced to the lower esophagus and the Barrett’s epithelium is examined  and length of Barrett’s is measured. A mucolytic agent (mucus dissolving substance) called Mucomyst is washed onto the esophagus to further clean and prepare the esophageal lining for treatment.

In the Halo 360 procedure, the first step is to measure the internal diameter of the esophagus using a sizing balloon catheter. Based on these measurements, a treatment balloon catheter is selected which most closely fits the patient’s esophageal dimensions. The treatment balloon catheter is advanced into the esophagus, inflated until the esophagus is fully dilated and a series of controlled bursts of radiofrequency are applied treating 3 cms of Barrett’s at a time.

The Halo 90 procedure does not require a sizing balloon to measure the esophagus. One size fits all. The device is simply attached to the scope, advanced to the desired area and ablation is performed.

Post Procedure Instructions-Halo 360

Observation

Patients are discharged from the hospital after a short observation period. It is unusual to have any complications from the procedure, but occasionally pain medication is given in the recovery room prior to discharge.

The next day

The day after your procedure, call the doctor’s nurse to review your instructions, and schedule your follow up endoscopy – to be done in 3 months. Make the nurse aware of any problems you are experiencing. Call your doctor at any time for severe symptoms after the procedure. There should be a doctor on call 24 hours per day to discuss unexpected problems from the procedure. If you are unable to reach the doctor, go to your local ER for immediate evaluation.

Medications after the procedure

The patients are instructed to take antacids (PPIs ie.  Nexium or Protonix) twice daily and are given several medications for any post procedural pain or nausea. It is important that patients take their antacid twice per day for the three months following the procedure.  Acid exposure to the esophagus during the healing phase may result in recurrence of Barrett’s.

The patient is also given several other medications in the event that there is any post operative discomfort, such as, pain or nausea.

Post Procedure Medications

                        Antacids

                                   * Nexium 40 mg ( or equivalent brand)before breakfast and dinner

                                      Take for at least 3 months without fail

                       Pain meds

                                   * GI cocktail liquid solution

                                     -consists of 5cc donatal, 20cc Maalox,

                                        and 5cc viscous lidocaine -a total of 30 cc per dose

                                      -provides immediate relief for pain in the esophagus                         

                                  * Percocet/Lortab – for pain

                         Nausea

                                    Phenergan or zofran for nausea 

Diet after Procedure

The patient is on a liquid diet for the first 24 hours- broths, shakes, and Gatorade are some examples. For the next week, patients will be placed on a soft diet. Avoid hard solid foods which cold scratch or irritate the lower esophagus. Talk to your scheduling nurse about the proper diet following the procedure.

Problems after the Procedure

Some patients may experience chest pain, tightness, burning and some difficulty swallowing for up to 2 weeks. Most patients, report symptoms are clearing up after 1 week. For any severe symptoms after the procedure, call your physician right away for instructions.

Rarely, an esophageal stricture or narrowing may develop requiring one or more dilations of the esophagus to improve swallowing. Patients with more than 2 weeks of severe swallowing difficulty should contact their doctor for further instructions.

Other complications which are true of any endoscopic procedure includes: perforation of the gastrointestinal lining requiring surgical repair, adverse events related to sedation used during the exam, post procedure infections, aspiration pneumonia, and gastrointestinal bleeding. Fortunately, these complications are very uncommon.

Follow up Endoscopy

Three months after the procedure, another upper endoscopy is performed and the lower esophagus is examined and biopsied for evidence of remaining Barrett’s. If no Barrett’s remains, the patient will usually be seen in one to three years for follow up endoscopy. If Barrett’s esophagus is present, a repeat ablation procedure is scheduled. There are exceptions to these rules, discuss follow up care with your physician.

The obvious question is, "What should I do to lower my cancer risk if I have Barrett’s?" While not much has proven to lower your risk of cancer, there are several logical steps you may take that we believe should help.

The primary factors which are associated with cancer risk include the presence of dysplasia on esophageal biopsy, the length of Barrett’s, obesity, uncontrolled reflux, alcohol/tobacco excess, vitamin deficiencies and a family history of esophageal cancer.

So… what to do? First, you need to know whether your esophageal biopsies showed dysplasia or not . This is probably the most important risk factor to get straight. Ask your doctor if the pathologist reported any evidence of dysplasia on the biopsy specimens from endoscopy. Keep in mind that there are grades of severity for Barrett’s and dysplasia.  Each dysplasia grade level has an incrementally higher associated risk for developing into cancer.

"Low grade dysplasia" (LGD) and "indeterminate dysplasia"  are not as concerning– though they do raise cancer risk. If you have LGD, an annual endoscopy is usually recommended to be sure your Barrett’s is "stable" and not progressing.

On the other hand, the presence of intermediate or high grade dysplasia especially gets our attention. High grade dysplasia has a very strong association with cancer and requires close monitoring– often requiring an endoscopy every 3 months or even immediate therapy– an esophagectomy (surgical removal of the esophagus). Endoscopic ablation may also be useful in treating high grade dysplasia Barrett’s, especially in older individuals not wanting to undergo surgery. It is also important to know if there were nodular areas within the Barrett’s lining as these areas may have some underlying cancerous changes not appreciated on the surface biopsies.

Unfortunately, our ability to predict cancer risk based upon the grade of dysplasia is not totally reliable. Though low grade dysplasia is considered "lower risk" than high grade dysplasia for malignancy, there are several reports of LGD Barrett’s progressing to cancer within a very short period of time. To compound the situation, there exist many reports of high grade dysplasia remaining stable for several years or even reverting back to a lower grade of dysplasia. How confusing!

The next important factor for cancer risk is length of Barrett’s. During your endoscopy, the physician will obtain a measurement of your Barrett’s taken from the bottom of the esophagus( the GE junction) to the top of the Barrett’s.  Around 1-2 cm of BE is pretty common. More than 3 cm (aka. long segment Barrett’s) is getting up there. Reports of Barrett’s esophagus > 10 cm are not uncommon - that is really long! The point is, the more Barrett’s, the more chance one of those Barrett’s cells could become cancerous. Unfortunately,there is really nothing you can do about the amount of Barrett’s you have. Some investigators have shown evidence of regression of Barrett’s if acid reflux is well controlled, but not everybody agrees with this observation. Most physicians report that the length of Barrett’s rarely changes over time, and antacids used to control reflux do not seem to affect the length of BE.

There is indirect evidence, however, that treatment of reflux may lead to decreased cancer risk. Studies of Barrett’s in the laboratory have shown less proliferation or activity of Barrett’s cells when acid exposure was absent. Pulses of acid exposure, however, led to marked activity in the Barrett’s cells. Investigators conclude that acid exposure to Barrett’s tissue may lead to stimulation of the Barrett’s and possibly more risk of cancer. Since Barrett’s seems to be caused by acid reflux, it seems logical to have a management strategy which prevents further reflux. Most physicians place patients on a strong antacid, even if they don’t complain of heartburn! We want acid out of the picture!!

Some patients also opt for surgical therapy to prevent reflux. There are several methods of tightening the lower esophageal sphincter which can really reduce acid exposure to the lower esophagus. Anti-reflux surgery is another one of those possibly helpful but unproven therapies. It clearly makes sense that a procedure to reduce acid reflux would be beneficial in BE, but more time is needed to assess the real benefits of these procedures. Understandably, Barrett’s patients want to do everything possible to prevent worsening of their condition, and an anti-reflux procedure is not necessarily a bad idea, just not totally proven.

Obesity is another major factor which raises the likelihood of cancer from Barrett’s. It is not clear why, but obesity has been identified in many studies as a factor that greatly increases cancer risk. Obese or overweight patients with Barrett’s should begin an exercise and weight loss plan . Obesity is an important, but often overlooked component of Barrett’s management. Fad diets are not our goal, rather, daily exercise, avoidance of high calorie foods, and portion control are all characteristics of healthy longterm weight loss.

Nutrition is also very important for reducing your cancer risk. Avoiding foods high in saturated fat and increasing your intake of raw fruits and vegetables is a good idea. A daily multivitamin with folate is also recommended. There have been studies from around the world demonstrating that nutritional deficiency can lead to higher esophageal cancer rates. Selenium deficiency was clearly associated with increased esophageal cancer in a population study in rural China. A word of caution, please don’t over do it with vitamins; try to resist the temptation to "load up" at your local vitamin store. Vitamins can be dangerous to your health if used improperly. You should take a daily multivitamin with folate and selenium and carefully select other vitamins and supplements with your physician’s guidance. There is a tremendous amount of research underway with vitamins and supplements which lower cancer rates, so stay tuned for more updates.

Finally, there is some really interesting data with the COX inhibitors. In case you didn’t know, a COX inhibitor would include medicines like aspirin, sulindac, Celebrex, Advil, Motrin, and Alleve. These common pain relievers are referred to as "NSAIDS". These agents may actually have an anticancer effect. Aspirin has been shown to reduce the likli-hood of many different types of gastrointestinal cancer, and the other NSAIDs may have a similar effect. COX stands for cyclo-oxygenase. Cyclo-oxygenase is an important cellular enzyme that stimulates inflammation and proliferation throughout the body.  Blocking this enzyme may lead to less inflammatory activity and less propensity  for a Barrett’s cell to become cancerous. An apple a day, may soon be replaced by an aspirin a day to keep the doctor away.

The only problem? many patient with Barrett’s, of course, have heartburn. Ironically, heartburn often worsens when a patient is on any NSAID like aspirin or the others. However, it may be worth a try, just don’t push it if heartburn becomes more severe. NSAIDS like aspirin also have other potential side effects such as elevated blood pressure, strokes, bleeding, and kidney problems. Talk to your doctor before ever taking a daily NSAID to reduce cancer risk from Barrett’s. There are several studies underway looking at the benefits of taking NSAIDs to prevent progression of Barrett’s esophagus to adenocarcinoma.

Alcohol and tobacco excess… another of the "unproven" but probable risk factors associated with Barrett’s progression to cancer. These agents have been associated with other malignancies and should be limited. On the other hand, alcohol in moderation, particularly red wine, may actually be beneficial. Alcohol excess, ie. more than two drinks per day, is possibly harmful. Tobacco appears to have only negative associations and even mild smokers may have an increased cancer risk from their Barrett’s. Smokeless tobacco, not certain, but not likely to help things.

So, to summarize… find out the specifics of your case: did your esophageal biopsies show dysplasia? -what level of dysplasia? - high grade - low grade? and how much Barrett’s do you have. These details really help to categorize your condition as "high" or "low" risk for cancer. If you have 9 cm of BE and high grade dysplasia, you need to get moving - you have a tremendous risk for cancer. However, you have 1 cm of Barrett’s, no dysplasia, you have a little more time. You are in the lowest risk category.

Be sure to see a specialist in Barrett’s esophagus - usually a gastroenterologist. Barrett’s is a condition that requires a great deal of knowledge and attention, you really need a sub-specialist for this one. And while you are considering your treatment options, go ahead and start doing things to reduce you cancer risk now!!! ie.) begin a diet and exercise program, increase your intake of fruits and vegetable, cut out foods high in animal fat, control your reflux with a daily antacid and an anti-reflux diet, take your Nexium or Protonix antacid daily, and consider taking an aspirin per day. Always talk to your doctor before beginning any new medicine.

The biggest decision after a diagnosis of Barrett’s is whether to undergo early endoscopic therapy to eradicate Barrett’s or stick with the conservative approach of regular endoscopic exams without treatment. There is a tremendous amount of research underway looking at ways to reduce cancer risk from Barrett’s esophagus and we will keep you posted as these findings are reported.                        

In the medical laboratory, the pathologist makes the official diagnosis of Barrett’s after looking at esophageal biopsy specimens under the microscope. Barrett’s tissue resembles the lining found in the lower intestinal tract and is characterized by the presence of "columnar" and "goblet" cells. The normal esophageal lining has a preponderance "squamous" cells rather than columnar or goblet cells. 

The pathologist will also determine if "dysplasia" is present. The determination of Barrett’s dysplasia is based upon the presence of several irregularities within cells that are not normally seen in healthy tissues. As more and more of these microscopic abnormalities are discovered, the dysplasia grade worsens. After reviewing all biopsy samples, the pathologist will give a final report of Barrett’s esophagus with - "no dysplasia", "indefinate dyplasia", "low grade dysplasia", or "high grade dysplasia."

So, what does all this mean? While the presence of dysplasia raises the risk of cancer, it is not cancer. Your doctor will analyze this information and make a decision concerning how often you should have an endoscopy or whether you should proceed to more aggressive therapy. A report of "no dysplasia" has the lowest risk for developing into cancer. On the other end of the spectrum, a report of "high grade dysplasia" is associated with the greatest risk for becoming cancerous.

Often, the physician will send your esophageal biopsies to a second pathologist to obtain another opinion. Occasionally there is some disagreement among the pathologists, particularly when only low grade dysplasia is apparent. Agreement is usually a little better in diagnosing high grade dysplasia. Your GI doctor will usually be the one to decide if a second opinion is needed. Second opinions are usually requested in cases of high grade dysplasia and before deciding if a patient should go to surgery.

How common is the diagnosis of low grade or high grade dyplasia? Results vary widely. Here are some examples from the literature:

1.) Schnell et al. Gastroenterology 2001; 120:1607.

Large series diagnosing Barrett’s esophagus - low grade dysplasia found in 70% of Barrett’s cases.

Note , this sounds a little high. In our Atlanta center, we estimate only 15-25 % of patients have dysplasia at diagnosis.

2.) Lao et al. Cancer 2004; 100:1622.

Large multi-center study with 790 Barrett’s cases– 4.7% found to have low grade dysplasia, 2.5% with high grade dysplasia.

This is quite a difference– one study showing 70% of Barrett’s patients with low grade dysplasia and another showing 4.7%. 

The next logical question is, "If I know I have Barrett’s and dysplasia, what is my actual risk of cancer?" The many studies seeking answers to this question have produced a variety of results. Below are some examples: 

Low grade dysplasia studies: 

1.) Skacel et al. Am J Gastroenterol 2000; 95:3383.

This study followed 25 patients with Barrett’s low grade dyplasia for an average of 26 months. Twenty-eight percent of these patients progressed to high grade dysplasia or cancer.

2.) Reid et al. Am J Gastroenterol 2000; 95:1669.

This study followed 43 patients with Barrett’s low grade dysplasia. The results were a twelve percent incidence of esophageal cancer at five years. 

3.) Hamerteen et al. Gastroenterol 1989; 96:1249.

This study followed 48 patients with Barrett’s low grade dysplasia. Ten percent of patients progressed to high grade dysplasia or cancer over a forty-one month period.

High grade dysplasia studies: 

1.) Reid et al. Am J Gastroenterol 2000; 95:1669.

This study followed 76 patients with high grade dysplasia and showed fifty-nine percent incidence of cancer over a five year period.

2.) Schnell et al. Gastroenterology 2001; 120;1607

This study followed 75 patients with high grade dysplasia. Sixteen percent developed esophageal cancer over a seven year period.

3.) Buttar et al. Gastroenterology 2001;120:1630.

This study followed 100 patients over an eight year period. Cancer developed in thirty-two percent.

This is just a small sampling of studies focusing on "Barrett’s with dysplasia" and "cancer risk." As you can see, there have been a wide range of findings for cancer risk in relation to low and high grade dysplasia. The association between cancer and Barrett’s dysplasia is under active investigation in centers from around the world, and these reports will continue to shed more light on the the true risk to patients with dysplasia.

Of course, dysplasia is only one of the risk factors which increase cancer risk in Barrett’s. In the next article "Cancer Risk from Barrett’s" we will discuss some other very important elements including diet, lifestyle, exercise, nutrition, and weight loss. Hopefully,with earlier detection of Barrett’s, more aggressive treatment of reflux, and close attention to risk factors we will begin to see significant reductions in cancer rates.