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

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ClinicalTrials.gov Identifier: NCT02104271
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Denise Peixoto Guimarães, 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.


Condition or disease Intervention/treatment Phase
Radiation Injuries Telangiectasis Rectal Bleeding Procedure: Argon Plasma Coagulation Procedure: Historical control Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Argon Plasma Coagulation
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

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.

Other Name: Argon gas

Active Comparator: Historical control
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

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.

Other Name: Argon gas




Primary Outcome Measures :
  1. Rectal bleeding rates [ Time Frame: 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.

  2. Occurrence of rectal ulcers [ Time Frame: 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.


Secondary Outcome Measures :
  1. Recurrence of rectal bleeding [ Time Frame: 6 and 12 months after the administration of the last dose of APC ]
    Abscence or recurrence of rectal bleeding.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104271


Locations
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Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400
Sponsors and Collaborators
Barretos Cancer Hospital

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Responsible Party: Denise Peixoto Guimarães, MD, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02104271     History of Changes
Other Study ID Numbers: 662/2012
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Denise Peixoto Guimarães, Barretos Cancer Hospital:
chronic radiation proctitis
argon plasma coagulation
rectal bleeding
Additional relevant MeSH terms:
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Proctitis
Telangiectasis
Hemorrhage
Radiation Injuries
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases