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

NCT02104271 | Completed Phase 2 DMC

• 1 other identifier: 662/2012
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injuries; Telangiectasis; Rectal Bleeding

Keywords

chronic radiation proctitis; argon plasma coagulation; rectal bleeding

Outcome Measures

Primary Outcomes (2)

• Rectal bleeding rates

  The proportion of patients with Complete Response at Week 4, 8, 12, 16, 20 and 24 defined as absence of bleeding.

  Up to four weeks after the administration of the first dose of APC and every four weeks after that up to 24 weeks

• Occurrence of rectal ulcers

  Presence of detectable rectal ulcers (\>10mm size or deep ulcers) on endoscopy.

  Up to four weeks after the administration of the first dose of APC and every four weeks after that up to 24 weeks.

Secondary Outcomes (1)

• Recurrence of rectal bleeding

  6 and 12 months after the administration of the last dose of APC

Study Arms (2)

Argon Plasma Coagulation

EXPERIMENTAL

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.

Procedure: Argon Plasma Coagulation

Historical control

ACTIVE COMPARATOR

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.

Procedure: Historical control

Interventions

Argon Plasma Coagulation PROCEDURE

APC was performed during sigmoidoscopy exam. Bowel preparation begins on the eve of the exam associated with waste liquid diet without oral intake of 10mg of bisacodyl (5mg/dragee) at 14 o'clock and 18pm and 130ml of phosfoenema (16g of sodium phosphate monobasic monohydrate and 6g of sodium phosphate dibasic heptahydrate per 100ml) diluted in 100ml of orange juice or lemon to 19h. On the day of the exam is administered 130ml of phosfoenema rectally immediately before the exam. All patients were previously sedated with fentanyl (0.05mg/ml), midazolam (5mg/5ml) and propofol (10mg/ml) and have intravenous introduction of the flexible colonoscope to the transverse colon to the exchange of gases following the routine of the Department of Endoscopy, Cancer Hospital Barretos.

Also known as: Argon gas

Argon Plasma Coagulation

Historical control PROCEDURE

APC was performed during sigmoidoscopy exam. Bowel preparation begins on the eve of the exam associated with waste liquid diet without oral intake of 10mg of bisacodyl (5mg/dragee) at 14 o'clock and 18pm and 130ml of phosfoenema (16g of sodium phosphate monobasic monohydrate and 6g of sodium phosphate dibasic heptahydrate per 100ml) diluted in 100ml of orange juice or lemon to 19h. On the day of the exam is administered 130ml of phosfoenema rectally immediately before the exam. All patients were previously sedated with fentanyl (0.05mg/ml), midazolam (5mg/5ml) and propofol (10mg/ml) and have intravenous introduction of the flexible colonoscope to the transverse colon to the exchange of gases following the routine of the Department of Endoscopy, Cancer Hospital Barretos.

Also known as: Argon gas

Historical control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Radiation Injuries; Telangiectasis; Gastrointestinal Hemorrhage

Interventions

Argon Plasma Coagulation; Lasers, Gas; Historically Controlled Study

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 4, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

BR (1)