Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic
radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are
difficult to treat and adversely impact patient quality of life. Various treatments directed
at the reduction of blood loss and improvement of other symptoms have been evaluated, with
the most encouraging results reported for two methods: endoscopic argon plasma coagulation
(APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of
sucralfate, a drug believed to enhance the mucosal defense and healing when administered
orally or rectally. Adequately powered randomized trials comparing various treatments are
lacking, and an optimal management strategy has yet to be determined. To address this issue,
we conducted a single-center, randomized, placebo-controlled, double-blind study comparing
the efficacy and safety of APC alone and APC in combination with sucralfate administered
orally.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
change in disease severity scores, as assessed using our three-item symptom scale
Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 >6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.
baseline vs. 16 week
No
Magdalena R Chruscielewska-Kiliszek, MD, PhD
Principal Investigator
Medical Centre for Postgraduate Education
Poland: Ministry of Science and Higher Education
501-2-1-09-14/03
NCT01613534
June 2003
June 2007
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