Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.

Phase 2

Completed

• Conditions: Rectal Bleeding; Radiation Injuries; Telangiectasis

• Registration Number: NCT02104271
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

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.

Detailed Description

APC is usually applied with a power of 40-60W and 1.2-2.5 L/min of gas flow by using a electrosugical generator coupled with an argon delivery unit. However, high gas flow have been associated to high rates of complication such as rectal stenosis and deep rectal ulcer.

In this context, the present study aims to compare the effectiveness and safety between two different paramenters of argon plasma coagulation (40-50W and 2.0 L/min of gas flow vs 40W and 1.2 L/min of gas flow) in the treatment of patients with symptomatic chronic radiation proctitis.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Primary Completion: 2014-12
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• > 18 years of age
• endoscopic diagnosis of chronic radiation proctitis
• previous pelvic radiotherapy
• presence of colonic or rectal telangiectasias
• patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• other causes of rectal bleeding besides chronic radiation proctitis diagnosed by complete colonoscopy , such as colorectal cancer , inflammatory bowel disease and polyps larger than 1 cm
• use of oral anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Recurrence of rectal bleeding	6 and 12 months after the administration of the last dose of APC	Abscence or recurrence of rectal bleeding.

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil