Status:
COMPLETED
Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Radiation Proctopathy
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
30,000 people in the UK are treated with pelvic radiotherapy each year. Rectal bleeding is a common symptom side effect caused by radiation proctopathy (RP). RP is due to the effect of radiation on th...
Detailed Description
Purastat is a new haemostatic agent (treatment that stops bleeding) which is licensed to treat bleeding from blood vessels in the gut. It is a liquid containing four peptides (protein building-blocks)...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age \>16 years old
- Pelvic radiotherapy completed \>6 months previously
- Endoscopically confirmed diagnosis of radiation proctopathy on lower GI endoscopy (sigmoidoscopy or colonoscopy) as characterised by the typical endoscopic appearances of superficial friable serpiginous telangiectasia, mucosal pallor and oedema
- Significant rectal bleeding (\>weekly passage of blood into toilet bowl +/- anaemia which is ongoing for at least 3 months)
- Full colonic evaluation (colonoscopy or CT colonogram) to exclude other causes for rectal bleeding
- Capable of providing informed consent to a participant information sheet written in English
- Exclusion criteria
- Age \<16 years
- Unable to have full colonic evaluation to exclude other causes of rectal bleeding
- Other untreated cause for rectal bleeding
- Previous Purastat treatment for RP
- Previous Sucralfate treatment for RP
Exclusion
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04918758
Start Date
July 22 2021
End Date
December 31 2024
Last Update
March 19 2025
Active Locations (1)
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1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WU