Prospective randomized comparison of EMR versus EMR followed by photodynamic therapy for the treatment of early barrett's cancer.

Endoscopic mucosal resection (EMR) can remove high grade dysplasia (HGD) and
early cancer (EC) within the Barrett's esophagus (BE). At the same time it is
an effective way for staging the disease, as it allows the pathologist to
assess the depth of malignant invasion with maximum precision. The risk of
major complications, such as bleeding and perforation, are significant, but low
in comparison with the risks of a surgical procedure.
Other endoscopic ablative therapies such as photodynamic therapy (PDT) and
argon plasma coagulation have also been shown effective in removing the
neoplastic and surrounding epithelium. PDT is typically used to treat larger
surface areas. Through the inherent destruction of the tissue exposed, it does
not provide a specimen for histopathologic evaluation; also the depth of
destruction is limited.
However, there is a major concern for the development of recurrent or
metachronous lesions after complete eradication of HGD and early-stage cancer,
using different endoscopic techniques. In order to reduce the risk of recurrent
neoplasia a combination of modalities is commonly used. However, the
additional yield of combined multimodality ablation is not well established and
further investigation should be undertaken.

In this project we will evaluate the added value of PDT after complete EMR in
patients with prior HGD and EC in Barrett*s esophagus.

This is a single center prospective randomized study carried out in the Erasmus
MC - University Medical Center Rotterdam. Patients with prior HGD and EC
(Vienna Class IV lesions) in Barrett*s esophagus, after radical mucosal
resection, will be randomly assigned to one of the two study arms. The first
will receive PDT and the second will receive no additional therapy after EMR.
Endoscopic control biopsies will be taken at 3 and 6 month after randomization,
and subsequently every 6 months until 2 years of follow up.

PDT: patients are given the photosensitizer 5-aminolevulinic acid at a dosage
of 40 mg/kg. Subsequently PDT is performed with a dye-laser, tuned at a
wavelength of 633 nm. The light is delivered to the esophageal mucosa via a
balloon mounted cylindrical diffuser. After PDT, patients are instructed to
avoid direct daylight by remaining inside and avoid excessive exposure to UV
light through other sources for 36 hours after ingestion of ALA.

None. PDT is the current standard treatment. In case of recurrence, the patient
will be referred to their treating physician for further treatment.