Sucralfate or placebo following argon plasma coagulation for chronic radiation
proctitis: a randomized double blind trial.
Author(s): Chruscielewska-Kiliszek MR(1), Regula J, Polkowski M, Rupinski M, Kraszewska E,
Pachlewski J, Czaczkowska-Kurek E, Butruk E.
Affiliation(s): Author information:
(1)Department of Gastroenterology and Hepatology, Medical Centre for Postgraduate
Education Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer
Center and Institute of Oncology, Warsaw, Poland. mchrusc@mp.pl
Publication date & source: 2013, Colorectal Dis. , 15(1):e48-55
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.
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