Bright T, Watson DI, Tam W, Game PA, Astill D, Ackroyd R, et al. Randomized trial of argon plasma coagulation versus endoscopic surveillance for barrett esophagus after antireflux surgery: late results. Ann Surg 2007 Dec;246(6):1016-20 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18043104.
randomised controlled trial
|High risk of bias||Comments: Well conducted study looking at the long term outcome after ablation using APC. The investigators were not blinded to the outcome. Follow up 5 years after initial therapy is important information for the question being addressed. Follow up after 5 years fell off to about 70% of the initial groups. Drop outs occurred equally in the two groups and are unlikely to influence results.|
Risk of bias assessment: randomised controlled trial
- Outcomes not blinded, substantial side-effects, or not reported.
- Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).
- Too many exclusions, differential loss in comparison groups, or not reported.
The field below is not considered when calculating the risk of bias rating
|2||Reason for decision: There was regression seem in both treatment and control arms of the study. The effect in the treatment group was significantly greater.|
|2||Additional comments: The study was conducted in patients with non-dysplastic Barrett's mucosa.|
Important study as it contributes to the question as to the durability of the Barrett's mucosa regression after ablation. The significant regression seen in the control arm is probably due to the fact that the study population was confined to patients whose reflux was controlled with a surgical fundoplication rather than medical therapy. This is a very important distinction as nearly all if not all studies evaluating ablation therapy use medical therapy (medication) to control reflux as part of their study design. The adequacy of reflux disease appears important to the outcome of all ablation therapies.
- Bright T, Watson DI, Tam W, Game PA, Astill D, Ackroyd R, et al. Randomized trial of argon plasma coagulation versus endoscopic surveillance for barrett esophagus after antireflux surgery: late results. Ann Surg 2007 Dec;246(6):1016-20 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18043104.
- Assigned to
- Topic area
- Clinical question
Section below only relevant for Cancer Council Project Officer