PTH-019 Bleeding during endoscopic resection: a novel extracellular scaffold matrix is a safe and effective haemostatic agent

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Abstract

Introduction

Bleeding is a well recognised complication of endoscopic resection (ER), particularly in endoscopic submucosal dissection (ESD). Electrocautery can be used to control bleeding but does increase the risk of perforation. A novel extracellular scaffold matrix (Purastat) has recently been approved for gastrointestinal haemostasis. This self-assembling peptide forms a transparent gel that can be applied via a catheter through the scope over the bleeding area.

Introduction

We conducted a feasibility study in a high bleeding risk cohort to assess its applicability, safety and efficacy. We also aimed to ascertain the mean volume of Purastat required to cover the resection base prophylactically.

Method

This was a prospective observational cohort study of patients undergoing complex ER in a tertiary referral centre from December 2015–2016. Purastat was used for prophylaxis over the resection base in high bleeding risk procedures or for primary haemostasis in active bleeding.

Method

Data was collected on patient and lesion characteristics including surface area, technical feasibility of gel application, haemostasis and delayed bleeding rate.

Results

Purastat was used in 74 patients (average age 69 years, male to female ratio of 2:1). All lesions were >2 cm and 33.8% (25/74) had cardiac co-morbidities with anticoagulant or antiplatelet usage reflecting a high bleeding risk. 60 (81.1%) had ESD and 14 (18.9%) had endoscopic mucosal resection. Table 1 shows the distribution of lesions according to location and size.

Results

Abstract PTH-019 Table 1

Results

Abstract PTH-019 Table 2

Purastat on its own was effective in stopping bleeding in 35/48 (72.9%) cases (see Table 2). It was successfully applied in all patients with no interference in visibility or catheter blockage

The mean surface area of the resection base was 16.2cm2 requiring a mean Purastat® volume of 2.7mls, or 0.2mls/cm2.

Purastat on its own was effective in stopping bleeding in 35/48 (72.9%) cases (see Table 2). It was successfully applied in all patients with no interference in visibility or catheter blockage

On follow up in 1 month, delayed bleeding was noted in 3/74 (4%) patients. All were managed with endoscopic intervention and no transfusion was required.

Conclusion

Purastat was effective in controlling bleeding in almost ¾ of the cases where it was used for primary haemostasis. It is safe, easy to use and does not hamper ongoing ER. Only a small amount is needed to effectively cover the resection base for prophylaxis. Our data has demonstrated its potential as a novel haemostatic agent that can minimise bleeding during ER.

Disclosure of Interest

S. Subramaniam: None Declared, K Kandiah: None Declared, S Thayalasekaran: None Declared, G Longcroft-Wheaton: None Declared, P Bhandari Conflict with: Receives educational grants from Fujifilm, Olympus and Pentax

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