Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis

Not Applicable

• Conditions: Rectal Bleeding
• Interventions: Other: Hemospray

• Registration Number: NCT02233933
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis

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

Study Timeline

• Study First Submitted: 2014-08-28
• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-09
• Last Update Posted: 2014-09-09
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• bleeding from radiation proctitis

Exclusion Criteria

• pregnancy bleeding diathesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
argon plasma coagulator and hemospray	Hemospray	treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
argon plasma coagulation	Hemospray	argon plasma coagulation of radiation proctitis

Primary Outcome Measures

Name	Time	Method
cessation of rectal bleeding	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 Outcome Measures

Name	Time	Method
number of treatments required to achieve cessation of rectal bleeding	12 months

Trial Locations

Locations (1)

British Columbia Cancer Clinic; 🇨🇦 Vancouver, British Columbia, Canada