Hage M, Siersema PD, van Dekken H, Steyerberg EW, Haringsma J, van de Vrie W, et al. 5-aminolevulinic acid photodynamic therapy versus argon plasma coagulation for ablation of Barrett's oesophagus: a randomised trial. Gut 2004 Jun;53(6):785-90 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15138203.
randomised controlled trial
|High risk of bias||Comments: Randomisation appeared good and ablation outcomes were assessed blindly by two observers. Follow up was complete. The study appears to have been well conducted. Three treatment arms were including making numbers in each group relatively small. There were two groups treated with different PDT protocols and the third group was treated with APC.|
Risk of bias assessment: randomised controlled trial
- Outcomes not blinded, substantial side-effects, or not reported.
- Inadequately concealed (e.g. numbered/sealed envelopes, alternation, medical record number, date of birth).
- No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).
The field below is not considered when calculating the risk of bias rating
|2||Reason for decision: The actual p value for the difference in outcome between the three groups is not quoted. A p value of <0,05 is only given. Nonetheless the effect is consistent in all three groups and clearly the treatments do cause regression of Barrett's mucosa.|
|2||Additional comments: The outcome was assessment of Barrett's regression which a relevant outcome. The treated group were mostly non-dysplastic with a few subjects included with low grade dysplasia. Whether the outcome is transferrable to patients with high grade dysplasia or early stage Barrett's cancer is not clear.|
- Hage M, Siersema PD, van Dekken H, Steyerberg EW, Haringsma J, van de Vrie W, et al. 5-aminolevulinic acid photodynamic therapy versus argon plasma coagulation for ablation of Barrett's oesophagus: a randomised trial. Gut 2004 Jun;53(6):785-90 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15138203.
- Assigned to
- Topic area
- Clinical question
Section below only relevant for Cancer Council Project Officer