Introduction

Aims & Methods

Results

Conclusion

References

Introduction

Radiation proctopathy (RP) is a common late complication of pelvic radiotherapy, affecting up to 20% of patients treated for pelvic malignancies. It manifests as rectal bleeding, anaemia, urgency, and diarrhoea, significantly reducing quality of life. Argon Plasma Coagulation (APC) remains the standard endoscopic therapy but has notable limitations, including high recurrence rates, the need for multiple sessions, and risks such as ulceration and perforation.
PuraStat, a synthetic self-assembling peptide hydrogel, offers an innovative alternative by creating a transparent matrix that promotes haemostasis and mucosal healing without thermal injury. While small series have shown benefit, robust real-world evidence is lacking.

Aims & Methods

We assessed real-world outcomes of PuraStat in RP at a UK tertiary centre (2023–2024). Consecutive patients with chronic radiation-induced rectal bleeding were included and treated by a single endoscopist. Patients were stratified into two cohorts:
1. De novo PuraStat – no prior APC (n=50)
2. APC→PuraStat – persistent or recurrent symptoms despite APC (n=50)
PuraStat was applied during flexible sigmoidoscopy, either as monotherapy or following APC. The primary outcome was resolution or improvement of rectal bleeding. Secondary outcomes included the number of repeat endoscopic interventions within 6 months and treatment-related adverse events.

Results

A total of 100 patients were included (median age: 74 years, range 64–85; 52% male). Most had prostate or gynaecological cancer treated with pelvic radiotherapy.
- De novo PuraStat (n=50): All achieved symptomatic relief, with marked bleeding reduction and endoscopic improvement. Follow-up sigmoidoscopy showed mucosal healing or mild residual proctitis in 92%. Mean repeat sessions: 1.3 (range 0–3) over 6 months.
- APC→PuraStat (n=50): These patients had undergone a median of 3 APC sessions with limited success. PuraStat led to complete symptom control in all cases, reducing the need for frequent interventions (mean: 1.5 sessions over 6 months).
No adverse events (e.g., perforation, infection, severe pain) were reported in either group. Patients with severe radiation-associated vascular ectasia (RAVE) and refractory bleeding demonstrated excellent response to PuraStat.

Conclusion

This large real-world series demonstrates that PuraStat is a safe, effective, and well-tolerated therapy for radiation proctopathy, whether used as first-line treatment or following APC failure. It provided rapid and sustained bleeding control, significantly reduced the need for repeat endoscopic interventions, and promoted mucosal healing without the risks associated with thermal therapies. Importantly, PuraStat showed consistent efficacy even in patients with severe radiation-associated vascular ectasia (RAVE) and those refractory to conventional modalities, highlighting its role as both a frontline and salvage option. These findings position PuraStat as a valuable addition to the therapeutic armamentarium for radiation-induced rectal bleeding. Larger prospective, multicentre studies and cost-effectiveness analyses are warranted to validate these results and define its optimal place in treatment algorithms.

Table 1: Treatment Outcomes by Group

References

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