Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
Overview
Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis
Full Title of Study: “Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
Detailed Description
20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination
Interventions
- Other: Hemospray
- hemospray is used after argon coagulation to stop bleeding
Arms, Groups and Cohorts
- Active Comparator: argon plasma coagulation
- argon plasma coagulation of radiation proctitis
- Experimental: argon plasma coagulator and hemospray
- treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
Clinical Trial Outcome Measures
Primary Measures
- cessation of rectal bleeding
- Time Frame: 12 months
- treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray
Secondary Measures
- number of treatments required to achieve cessation of rectal bleeding
- Time Frame: 12 months
Participating in This Clinical Trial
Inclusion Criteria
- bleeding from radiation proctitis Exclusion Criteria:
- pregnancy bleeding diathesis
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- British Columbia Cancer Agency
- Provider of Information About this Clinical Study
- Principal Investigator: Alan Weiss, Principal Investgator – British Columbia Cancer Agency
- Overall Official(s)
- Alan A Weiss, MD, Principal Investigator, BCCA
- Overall Contact(s)
- Alan A Weiss, MD, 7789979332, aweiss@bccancer.bc.ca
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