Barrx Presentation

[daw]

Presentation at May Digestive Disease Week 2005

Presentation Number: S1691

Disclosures: None

A Prospective Multi-Center Evaluation Of Ablation Of Non Dysplastic Barrett’s Esophagus Using the Barrx Bipolar Balloon Device. the Ablation Of Intestinal Metaplasia (aim)-Ii Trial.

Authors: D.E. Fleischer, V. Sharma, A. Reymunde, M. Kimmey, R. Chuttani, B. Overholt, K. Chang, C. Lightdale, N. Santiago, D. Pleskow, P. Dean, K. Wang

Aims: To evaluate the effectiveness, safety& tolerability of ablating non-dysplastic esophageal intestinal metaplasia (IM) using the BARRx device.

Methods: Multicenter, prospective trial in 70 patients with 2-6 cm of esophageal IM treated at 300 W; 10 J/cm2. The BARRx device has a bipolar electrode catheter encircling an esophageal balloon. In our pilot study (AIM-I) these settings resulted in circumferential ablation of IM to the muscularis mucosae while lower energy density settings resulted in insufficient ablation. All patients received esomeprazole (40 mg bid) 1 mo post-ablation, then 40 mg qd. Patient tolerability was assessed using 0-100 VAS querying peri- & 2 hr post-procedure discomfort, & a 14-day symptom diary.

All patients had EGD at 1, 3, 6 mo with 4-quadrant, q 2 cm biopsies (bx), using maximum capacity forceps; interpreted by a central/ blinded pathologist. Complete Response (CR) = all bx negative for IM; Partial Response (PR) = 50-99% bx negative for IM. Biopsy clearance rate (BCR) = % negative bx / patient at each time interval. Data reported for 1 and 3 mo represent single treatment results. If bx positive for IM at 1 or 3 mo, patients were offered a second treatment at 4 mo.

Results: Seventy patients (50 men, mean age 56.0 years, range 26-79, mean IM 3.5 cm) enrolled at 8 centers. Median procedure time = 29 min (range 3-62). RF delivery time <1 sec / 3 cm IM. All tolerated the procedure well, with low discomfort scores on exit survey & 14-day diary (median scores <20/100, complete resolution <5 day). At follow-up EGD, there was complete epithelial healing with no strictures. There were no “buried Barrett glands” in1305 follow-up bx.

At 3 mo, CR and PR rates are 41% & 54%, respectively; median BCR of 88%. Patients not in CR at 3 mo, nonetheless had the majority of their IM eliminated, with typically minute foci of IM remaining. These patients are receiving a second treatment at 4 mo. Complete follow-up at 3, 6 mo is pending.

Conclusion: The BARRx bipolar balloon device is effective in creating a circumferential ablation of IM without any significant complications, stricture formation or buried glands. Single treatment CR is 43%, while remaining patients demonstrated significant reduction in IM surface area. These results suggest that IM can be safely removed after a single treatment in a significant proportion of patients & those with residual IM can be safely retreated.

[konyw1]

:confused: I had a biopsy of the esophagus, my Nurse, who I was seeing, told me, i had Barrett's disease. She explained, it was at an early stage, and with an agressive treatment, I should be all right. She refered me to a G.I., still waiting for the appoinment. It has been almost 4 weeks. I called, two days later, to have the spelling of the disease, since I had never heard of it before. I have had brain cancer, and finding out about this Barrette's issue, was not a welcome happening in my life. I went to a real Doctor, for a second opinion, and to give me a copy of the biopsy. He told me, i did not have Barrett's disease. what the biopsy reads is: GERD 7 short segment Barrette's. No goblet cell intestinal metaplasia is seen to suggest a diagnosis of BARRETT'S esophagus on morpholgic grounds. No dysplasia is seen. Squamos epithelium with basal cell hyperplasia. accentuation of rete ridges and intraeepithelial lymphocytes, suspicious for reflux esophagitis, no eosinophil infiltrate is seen. He told me, I do not have Barrett's. They might want to operate on me, and take some of the esophagus, but it was better to wait and see the G.I. doctor. I don't really understand this pathology report, is it all right to have someone, or anyone who is interested, in letting me know, what do you read in this report? Is Barrette's cancer? I would really appreciate it, be looking out for comments konyw

[daw]

Hi konyw1.
Your pathology report stated: " No goblet cell intestinal metaplasia is seen to suggest a diagnosis of BARRETT'S esophagus on morpholgic grounds. No dysplasia is seen. Squamos epithelium with basal cell hyperplasia. accentuation of rete ridges and intraeepithelial lymphocytes, suspicious for reflux esophagitis, no eosinophil infiltrate is seen."

The nurse should not have told you that you had Barrett's. I'm not sure where she got that idea. A doctor can make a guess at what he sees but the biopsy is the only thing that can tell you if you really have Barrett's. According to this report you DO NOT have Barrett's. You most likely have GERD (acid reflux) and the GI should prescribe some medications for you if your regular doctor hasn't already. No one should operate on you and take out some of your esophagus. Some people get an operation called a fundoplication to prevent acid reflux into the esophagus but that's only done when people don't want to stay on medications long term or the medications don't help them.

Barrett's is not cancer. It is a precurser. For those who have Barrett's the likelyhood of them getting esophageal cancer is still low (but higher than those who don't have Barrett's). Barrett's cells must change into low dysplasia and then high dysplasia before changing into cancer. If you want to read more about Barrett's there is a good website: http://www.barrettsinfo.com

Going to a GI doctor is a very good decision. Good luck and let us know how the appointment goes.

[daw]

Konyw1,
Also....If you are confused because the beginning of the report states: "GERD / short segment Barrett's....many times the doctor who is doing the endoscopy and biopsy will put down his(her) diagnostic impression of what is seen upon gross visual inspection. The pathologist's statements about what is seen under the microscope is the defining diagnosis.

[konyw1]

:) I am extremelly grateful for your answer to my biopsy report, for my esophagus. I am so happy to read that I do not have barrett's, as the Nurse told me, I had it. That is why, I persisted on seeing a real "Doctor", sorry. This is not the first time they have made this kind of mistakes, I am going to talk to a Lawyer, I feel their actions are terribly irresponsible. Thanks again, I can sleep tonight. Have a wonderful weekend konyw

[konyw1]

I finally went to see my real "Doctor". i had changed doctors, because mine is very far away from my house, not a good idea. She is sending me to a G.I. Doctor, very well known in town. The nurse from before, had prescribed, PROTONIX, for my stomach, instead of nexium. How is it, has it worked for anyone else? It makes me sleepy. I also got a prescription from my rheumalogist, ( i am not sure how to spell it)METHOCARBAMOL 500 mg. muscle relaxant. Lost my memory, very confusing, that is what I have experienced, with just one. I would appreciate comments, thanks so much,
konyw. Please get my email from the administrator if you wish to send me a note. webmaster@heartburn-help.com

[daw]

....I also got a prescription from my rheumalogist, ( i am not sure how to spell it)METHOCARBAMOL 500 mg. muscle relaxant. Lost my memory, very confusing, that is what I have experienced, with just one. I would appreciate comments, thanks so much,
Hi konyw1,
Methocarbamol is used for painful musculoskeletal conditions and can make you drowsy, dizzy, light headed,etc.. I would call the doctor about the memory loss and confusion....especially if you feel this way after only one 500mg pill. Also, don't drink alcohol or take any other central nervous system depressants while on this drug.

[konyw1]

I want to thank you, again, for the information about this medicine. I was so confused, and light headed, it was avery strange feeling. Not high, not speedy, just kind of "there". I could not get all the words out, of what I was thinking, it would take me a while, or not at all. People, had to finish the sentences for me. That was frustrating. It worked for the muscle spasm, but I called my Doctor, and she told me not to take it anymore. Thank God, I don't take my percocet, it says, in what I read, over the internet, that is dangerous to mix, with opiods, and antidepressants. That is why, i am trying to get my psychiatrist and mypain doctor, to be to gether in my treatment.

Thanks alot, konyw