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Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.
There is a wide variability of options for treatment of chronic radiation proctitis. However, studies are still limited, usually case reports from a single center and few are comparative studies between methods. Therefore, the choice of treatment is determined by availability and local expertise for each method. The variability of treatment options range from anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic treatment modalities have been reported. Formalin topic is effective in up to 48% of patients with chronic radiation proctitis. The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and transportation, safe and effective in the treatment of rectal bleeding in patients with chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality. Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency, diarrhea and tenesmus in 60% to 75% of cases.
Details
| Lead sponsor | Barretos Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 41 |
| Start date | 2013-01 |
| Completion | 2015-08 |
Conditions
- Radiation Injuries
- Telangiectasis
- Rectal Bleeding
Interventions
- Argon Plasma Coagulation
- Historical control
Primary outcomes
- Rectal bleeding rates — Up to four weeks after the administration of the first dose of APC and every four weeks after that up to 24 weeks
The proportion of patients with Complete Response at Week 4, 8, 12, 16, 20 and 24 defined as absence of bleeding. - Occurrence of rectal ulcers — Up to four weeks after the administration of the first dose of APC and every four weeks after that up to 24 weeks.
Presence of detectable rectal ulcers (\>10mm size or deep ulcers) on endoscopy.
Countries
Brazil