Multi-band mucosectomy plus BARRx Radiofrequency Ablation for Eradication of High-Grade Dysplasia and Early Cancer in Barrett's oesophagus.

Patients with Barrett's Esophagus (BE) undergo endoscopic surveillance to
detect malignant progression in their esophagus at an early and curable stage.
Patients with High Grade Dysplasia (HGD) are considered to have a significantly
increased risk for development of esophageal cancer (i.e metachronous cancers).
For patients with HGD that have visible abnormalities in their BE it is
therefore advised to extensively biopsy these abnormalities and preferably to
have them removed by endoscopic resection (ER) to exclude an invasive cancer
before deciding on further management. The most widely practiced ER technique
is the ER-cap technique in which the target lesion is lifted by submucosal
fluid injection, usually using diluted adrenaline (1:100.000). Subsequently, a
transparent cap is attached to the endoscope. This cap has a distal ridge that
allows positioning of a special ER-snare. The lesion is sucked into the cap and
the snare is closed thus creating a pseudo-polyp that is then removed using
electrocoagulation. In one study a local remission of 98% was achieved by ER
(19). This procedure is safe and serious complications are rare (20). Minor
complications, such as minor bleeding, occur in 9% of the cases and usually are
easily managed endoscopically (19). Drawback of the ER-cap technique is that it
a technically demanding procedure that requires submucosal injection, placement
of the ER-snare in the ridge of the ER-cap, and a new ER-snare for every
resection.Recently, a prototype ER device (Wilson-Cook Medical, Limerick,
Ireland) has become available that may allow for removal of multiple specimens
without the need for a high-level of endoscopic experience. This device uses a
modified variceal band ligator that has multiple rubber bands attached to a
standard variceal ligation cap. This technique has several advantages, with the
current MBM prototype, up to six consecutive resections can be performed (the
instruments holds six rubber bands) without withdrawing the endoscope. This
reduces the time required for the procedure as well as cost and patient
discomfort.
A drawback of ER is that only focal lesions are removed whereas the remaining
Barrett's mucosa left untreated. Since this mucosa has a *field defect* new
neoplastic lesions may develop elsewhere in the BE during follow up. Studies
have shown that after ER, 30% of the patients may develop such metachronous
lesions. Some centers have therefore advocated the use of adjuvant treatment
with additional ablation therapy to minimize this risk.
At the Academic Medical Centre in Amsterdam, over 50 patients with HGD/EC have
been recently treated by stepwise radical endoscopic resection (SRER) in which
the whole Barrett*s segment is removed through consecutive ER sessions. This
not only reduces the potential risk of metachronous lesions, but also provides
a complete tissue sample for histological correlation. Drawback of SRER is that
it requires multiple treatment sessions and carries an increased risk (30-70%)
for esophageal scarring and esophageal stenosis.
Endoscopic ablation therapy is used for treatment of selected patients with HGD
in a Barrett*s esophagus. Endoscopic ablation therapy is also used as an
adjuvant treatment after EMR for early Barrett*s cancer to treat any hidden
areas of synchronous neoplasia and/or to reduce the rate of recurrences during
follow-up.
Photodynamic therapy (PDT) and Argon Plasma Coagulation (APC) are the most
widely used techniques in this respect. These techniques are, however,
associated with significant drawbacks: PDT is expensive and uncomfortable to
the patient.Radiofrequency ablation (RFA) is a new promising endoscopic
ablation technique that may overcome some of the aforementioned drawbacks of
PDT and APC.At the Academic Medical Centre in Amsterdam, 11 patients with
LGD/HGD have been recently treated with HALO-360 RFA to ablate their dysplasia
and Barrett*s mucosa. Treatment was without significant complications. Complete
eradication of all dysplasia was achieved in 91% after the initial treatment
period (2 endoscopic treatment sessions allowed with a 2 months interval) and
in all patients the esophagus healed without scarring or stenosis.

The purpose of this project is to evaluate the combination of ER using the
multi-band mucosectomy technique and RFA (HALO360/HALO90) for treatment of
Barrett*s esophagus with HGD or early cancer. This will be a multi-centre
European study including three tertiary referral centres for the endoscopic
treatment of early Barrett*s neoplasia. An arbitrary number of 12 patients per
centre will be included.

Twelve patients with a Barrett's esophagus and high grade dysplasia or early
cancer will be included at each center (AMC, Evangelisches Krankenhaus,
L'Hopital Erasm). Patients will undergo an endoscopic resection with the MBM
technique for a focal lesion.
Additionally two or three Radio Frequency Ablation sessions will follow. At six
and twelve months follow-up primary and secondary endpoints will be assessed.

Patients will be treated for their Barrett's esophagus with dysplasia or early
cancer. Patients will undergo an endoscopic resection with the MBM technique
for a focal lesion followed by RadioFrequency Ablation to ablate the remaining
Barrett's mucosa.

For endoscopic resection usually the ER-cap or MultiBandMucosectomy is
performed. These procedures are safe and serious complications are rare. Minor
complicartions such as minor bleeding, occur in 9% of the cases and usually are
easily managed endocopically.
Stepwise radical endoscopic resection (SRER) is used as treatment for
eradication of the barrett's esophagus. Drawback of SRER is that it requires
multiple treatments which are time consuming per session and uncomfortable to
the patient. Moreover, SRER carries an increased risk (30-70%) for esophageal
scarring and stenosis.
Radiofrequency Ablation is a new promising technique which is significant less
invasive than SRER. We anticipate a 5% rate of acute complications and a 5%
late stenosis rate due to esophageal scarring.