Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 the rectum (back passage) which causes poor blood supply (ischaemia) which leads to stiffness/scarring (fibrosis) and the development of abnormal blood vessels on the surface of the lining of the rectum (telangiectasia) which can bleed (1, 2). Six percent of patients will develop severe bleeding from RP (3), passing large amounts of blood and clots, often leading anaemia (low blood count) requiring either tablet or intravenous (IV) iron replacement, or blood transfusion.

There are very few safe, effective, evidence-based treatments available for RP. 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). When this liquid comes in contact with blood these peptides join together to form a mesh which closes the broken blood vessel thereby stopping the bleeding (4-7). Purastat is safe with no side effects and it breaks down amino acids, which are tissue building blocks that can be used to repair the site of injury (7). There are many studies which show that Purastat® is effective at stopping bleeding quickly and safely (within 10-20 seconds) (6-13). Early data from a case series of 21 patients by the research team has shown improvement in symptoms and endoscopic appearance. This study is a dual site randomised feasibility study of 80 patients. It will obtain initial data into the safety and efficacy Purastat in reducing bleeding in people with severe haemorrhagic RP. These data will be used to support funding for an definitive randomised controlled trial.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manchester University NHS Foundation Trust
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Sucralfate

Criteria

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