A randomized trial comparing radiofrequency ablation with step-wise radical endoscopic resection for treatment of Barrett*s esophagus with high-grade dysplasia or early cancer.

Patients with a BE are kept under endoscopic surveillance to detect malignant
progression in their esophagus at an early and curable stage.
Endoscopic ablation therapy is used for treatment of selected patients with HGD
and early cancer in a Barrett*s esophagus. In addition, several groups have
also treated LGD-patients with different ablation techniques in the past.
Photodynamic therapy (PDT) and Argon Plasma Coagulation (APC) are the most
widely used techniques in this respect. Both are, however, associated with
significant drawbacks. PDT is expensive and uncomfortable to the patient. APC
is most effective at higher energy settings where it may be associated with
severe complications such as perforation and stenosis. After PDT and APC, a
substantial number of patients have residual Barrett*s epithelium, and small
areas of intestinal metaplasia and/or dysplasia may remain hidden underneath
neosquamous mucosa. There have been anecdotal reports of submucosal cancers
that occurred during follow-up after PDT and APC. PDT is not used in our
department due to bad results and the discomfort for our patients.
Radiofrequency ablation (RFA) is a new promising endoscopic ablation technique
that may overcome some of the aforementioned drawbacks of PDT and APC.The probe
is manufactered by BARRx Inc, California, USA. In the USA the probe has ben
tested in multiple studies concerring Barrett's oesophagus. SRER (Stepwise
Radical Endoscopic resection) is the standard treatment in Europe for HGD
and/or early carcinoma in a Barrett's segment. By stepwise radical endoscopic
resection, SRER, the Barrett's mucosa including dysplasia or early carcinoma is
radicaly resected in consecutive sesions.
This study will tell us whether RFA is a suitable procedure to treat patients
with a barrett's oesophagus containing dysplastic cells.

The purpose of this study is to find answers for the following questions:
1. Is BARRX ablation a good alternative to step-wise radical endoscopic
resection for patients with a Barrett*s esophagus with high-grade dysplasia or
early cancer in terms of efficacy, early complication rate, late complication
rate and the presence of buried Barrett*s?
2. Does BARRX ablation preserve the functional integrity of the distal
esophagus as measured with 24 hour impedance measurement and micro-manometry.

This study is a randomized open trial in which 40 patients with a Barrett*s
esophagus with high-grade dysplasia or early cancer will be randomized to BARRX
ablation or SRER. Visible endoscopic lesions will be removed with EMR prior to
randomization.
10 patients in both groups will undergo sophisticated functional testing of the
esophagus before and six months after treatment using impedance planimetry and
manometry.

In RFA, the Barrett*s segment is ablated by radiofrequency ablation through a
specially designed balloon (HALO360) which contains a spindle shaped electrode
on its outer surface. Balloons with different diameters and lengths of
electrodes are available. The instrument has been developed by BÂRRx Inc,
California, USA and is FDA approved for ablation of Barrett*s mucosa. Studies
have shown that HALO360-RFA allows for quick, simple and effective superficial
ablation of the esophageal mucosa.
By stepwise radical endoscopic resection, SRER, the Barrett's mucosa including
dysplasia or early carcinoma is radicaly resected in consecutive sesions.

Step-wise radical endoscopic resection will require three to four procedures,
will be associated with an acute complication (mainly acute bleeding) during
one of these procedures in approximately 50% of patients, will be associated
with dysphagia during follow-up in 50% of patients and will effectively
eradicate high-grade dysplasia and early cancer in all patient but will be
associated with Barrett*s in 5 to 10% of patients.
BARRX ablation is expected to eradicate all Barrett's mucosa, have a 5 to 10%
rate of buried Barrett*s and be associated with acute complications in 5% of
patients and the development of stenosis in 5% of patients.