Introduction 30,000 people are treated with pelvic radiotherapy annually in the UK. Rectal bleeding is common following pelvic radiotherapy,one of the main causes being radiation proctopathy (RP). Radiation causes ischaemia and fibrosis,leading to neovascularisation with small friable vessels which are the source of bleeding. 6% develop severe bleeding from RP,leading to anaemia requiring iron +/- blood transfusion. There are very few safe,effective,evidence-based treatments.

Purastat is a haemostatic agent licenced for GI bleeding. It is a self-assembling peptide which forms a molecular mesh in contact with blood,thereby sealing blood vessels. There are numerous studies showing its efficacy and safety in various surgical/endoscopic settings. We report the first data for the use of Purastat for the treatment of RP.

Methods Consecutive patients attending pelvic radiation disease clinic with severe refractory RP were offered treatment with Purastat. This was defined as rectal bleeding into the pan +/- clots +/- anaemia with no response to rectal sucralfate +/- hyperbaric oxygen therapy (HBOT). Purastat was applied endoscopically at 4 weekly intervals up to 4 times. Severity of bleeding was recorded using patient diaries. Severity of RP was graded using the Zinicola score(1).

Results All 13 patients offered Purastat accepted treatment (10 male; 9 prostate, 2 vaginal, 2 rectal; median age 74 years (4–4)). 10 had previously used rectal sucralfate (3 were unable to due to mobility),2 had HBOT and 4 had APC. 3 were on antithrombotics (2 warfarin, 1 aspirin) and 1 had thrombocytopenia. 8 had anaemia at baseline and 9 required intervention (6 oral iron; 5 IV iron; 3 blood transfusion).

Median number of Purastat treatments was 3 (–). There was a reduction in median episodes of rectal bleeding (bleeding into the pan, n= 11) from 12 (–7) 7 days prior to the 1st treatment to 4 (–5) 7 days prior to the 2nd treatment. Endoscopic grade improved in 8 patients, with no change in 4 and an increase in 1,all of whom are awaiting a 3rd treatment. Mean haemoglobin at baseline,mid-treatment and after treatment was 111, 107 and 119 g/L respectively. There were no complications.

Conclusions Even in this cohort of the most severe cases of RP, there was an improvement in rectal bleeding and endoscopic grade. It is crucial that further data are obtained in a randomised controlled trial to determine the safety and efficacy of Purastat in this patient group to address this ongoing significant area of unmet clinical need and reduce associated morbidity and healthcare costs.

Reference

1. Zinicola R, et al. Haemorrhagic radiation proctitis:endoscopic severity may be useful to guide therapy. Int J of Colorectal Dis 2003;18(5):43–4.