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

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Rectal Bleeding; Radiation Injuries; Telangiectasis

Treatments: Procedure: Argon Plasma Coagulation; Procedure: Historical control

Study type: Interventional

Funder types: Other

Identifiers

NCT02104271

662/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Argon Plasma Coagulation

Experimental group

Description:

Argon Plasma Coagulation (APC) treatment will be delivered using a "spray-painting" technique, with short applications at 40W power and argon gas flow of 1.2 L/min. The APC equipment consists of a high frequency electrosurgical generator combined with a source of argon gas (Argon + SS601MC 4 , WEM Electronic Equipment Ltda , Ribeirão Preto , Brazil ). A flexible catheter of 2.3 mm diameter ( WEM ) Teflon coated and with a hint of heat resistant ceramic is inserted through the working channel of the colonoscope and connected to the current generator and the gas source for APC implementation.

Treatment:

Procedure: Argon Plasma Coagulation

Historical control

Active Comparator group

Description:

Argon Plasma Coagulation (APC) treatment was delivered using a "spray-painting" technique, with short applications at 40-50W power and argon gas flow of 2.0 - 2.5 L/min. The APC equipment consists of a high frequency electrosurgical generator combined with a source of argon gas (Argon + SS601MC 4 , WEM Electronic Equipment Ltda , Ribeirão Preto , Brazil ). A flexible catheter of 2.3 mm diameter ( WEM ) Teflon coated and with a hint of heat resistant ceramic is inserted through the working channel of the colonoscope and connected to the current generator and the gas source for APC implementation.

Treatment:

Procedure: Historical control