Barretts oEsophageal Resection With Steroid Therapy Trial
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer.
Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts
mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal
resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they
have premalignant or early malignant disease, it is a curative procedure.
Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue
development in the oesophagus, leading to stricture formation and difficulty swallowing
(dysphagia). If a safe and effective method could be found to reduce this risk, the treatment
options for early oesophageal cancer would be greatly improved. CBE is performed as a two
stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study,
eligible and enrolled patients are randomised after the 1st stage CBE to receive either
prednisolone tablets or placebo. Inclusion criteria are patients with short segment (<3cm
circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The
treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing
dose over the 6 weeks, starting at 40mg daily.
The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be
performed as required for dysphagia secondary to symptomatic oesophageal stricture formation
persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance
with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to
assess for complete removal of Barretts mucosa.
Following two stage CBE, stricture rates without preemptive therapy in noncircumferential,
circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70%
respectively. The investigators predict a 50% reduction in stricture rate with oral steroid
therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of
significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop
out rate, a total of 126 patients are required. The study will be performed at five
Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.