Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial
Article first published online: 20 DEC 2012
© 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland
Volume 15, Issue 1, pages e48–e55, January 2013
How to Cite
Chruscielewska-Kiliszek, M. R., Regula, J., Polkowski, M., Rupinski, M., Kraszewska, E., Pachlewski, J., Czaczkowska-Kurek, E. and Butruk, E. (2013), Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial. Colorectal Disease, 15: e48–e55. doi: 10.1111/codi.12035
- Issue published online: 20 DEC 2012
- Article first published online: 20 DEC 2012
- Accepted manuscript online: 24 SEP 2012 09:24PM EST
- Received 18 April 2012; accepted 16 July 2012; Accepted Article online 24 September 2012
- Post-radiation injury;
- argon plasma coagulation
Aim Chronic radiation proctitis is a long-term complication of radiation therapy for pelvic malignancy. The aim of this study was to compare the efficacy and safety of two treatment regimens, sucralfate or placebo, following argon plasma coagulation (APC) for chronic haemorrhagic radiation proctitis.
Method A single-centre, randomized, placebo-controlled, double-blind study was performed on patients with haemorrhagic chronic radiation proctitis after irradiation for prostate, uterine, cervical, rectal or vaginal cancer. All patients received APC, and were then randomized to oral sucralfate (6 g twice a day) or placebo treatment for 4 weeks. APC was repeated every 8 weeks if necessary after the first session. Patients were graded clinically and endoscopically according to the Chutkan and Gilinski scales before and at 8 and 16 weeks after initial APC treatment (1.5–2 l/min, 25–40 W) and after 52 weeks (clinical only).
Results Of 122 patients, 117 completed the entire protocol, with 57/60 in the sucralfate group and 60/62 in the placebo group. At baseline there were no significant differences between the sucralfate and placebo groups. At 1 year, a significant improvement in the clinical scale in both groups occurred compared with baseline. After 16 weeks, the median overall clinical severity scores fell from 4 to 2 points and the median bleeding score from 2 to 0 in both groups.
Conclusion APC is safe and effective for the management of chronic radiation proctitis. Additional sucralfate treatment did not influence the clinical or endoscopic outcome.