Self-sizing Radiofrequency Ablation balloon
for eradication of Barrett's esophagus: a
randomized trial comparing three different
treatment regimens

In this trial, three regimens for circumferential

radiofrequency ablation treatment with the RFA self-sizing

balloonWill be compared The first regimen is the standardly

used regimen (1x-clean-1x) The two simple regimens are

the simplified protocol with 2x-ablation-no clean and the

simplified protocol with 1x ablation-no clean.

The percentage of endoscopic resolution of Barrett’s esophagus at 3 months is non-inferior with two simple protocol versus the standard protocol.

1. At follow-up endscopy at 3 months after the circumferential RFA treatment the primary endpoint will be scored

2. During and in the interval from directly after the circumferential RFA procedure until follow-up endoscopy after 3 months, the secondary endpoints are scored

Circumferential radiofrequency ablation of Barrett's
esophagus with the Self-sizing RFA balloon.

Inspection of the Barrett’s segment and randomization
The esophagus is evaluated using white light high-resolution
endoscopy (WLE) and narrow band imaging (NBI). The
extent of columnar lined esophagus is documented according
to the Prague C&M classification15 and by taking still images
with WLE+NBI at 1 cm intervals. In the absence of visible
abnormalities and no severe stenosis, patients are
subsequently randomized to circumferential ablation with the
Self Sizing RFA balloon using the simplified or the standard
ablation regiment.

Patients will be blinded for the administered treatment
regimen.

Standard ablation regimen
After mapping and randomization, the Barrett’s segment is
flushed with the mucolytic agent acetylcysteine (1%)
followed by flushing with tap water. The Self Sizing RFA
balloon (GI Solutions Covidien, Sunnyvale, CA) is then
introduced and positioned at the desired treatment zone. The
device is inflated, and the electrode unfurls until the
electrode contacts the esophageal wall. Under visual control
the BE is ablated (12 J/cm2 at 300 Watt) working proximal
to distal using visual repositioning. A small overlap (i.e.
<1cm) between ablation zones is allowed. After the first
ablation pass, the endoscope is removed followed by removal
of the ablation catheter. The coagulum is cleaned off the
balloon catheter. The endoscope is reintroduced to irrigate
and suction the ablation zone. A distal attachment cap may
be attached to the tip of the endoscope to gently wipe of the
coagulum from the ablated segment. After irrigating and
suctioning the debris away as much as possible, the Self
Sizing RFA RCT November 2014 vs 1 Page 10 van 16
ablation zone is cleaned by forcefully flushing water through
a spraying catheter. The stomach is emptied and deflated,
the endoscope is removed and the ablation catheter is
reintroduced to repeat the ablation. After this second
ablation no additional cleaning of the ablation zone is
required. First, the endoscope is removed, followed by
careful removal of the ablation catheter.

Simplified ablation regimens:
In the first simplified ablation regimen flushing with the
mucolytic agent acetylcysteine (1%) is not performed, but
the esophageal wall will cleaned with water through the
waterjet channel of the endoscope. After the first ablation
(12 J/cm2 at 300W), immediately a second ablation is
performed of the same zone without a cleaning step. After
deflation, the balloon is advanced distally to ablate
subsequent zones with a double ablation in an identical way.

In the second simplified ablation regimen flushing with the
mucolytic agent acetylcysteine (1%) is not performed, but
the esophageal wall will cleaned with water through the
waterjet channel of the endoscope. There is only one
ablation instead of two.