Gastrointestinal Haemorrhage Clinical Trial
Official title:
Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat
superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered
problem during submucosal dissection and is usually managed with electrocautery. However,
this does carry a risk of deep thermal injury and perforation.
PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent
adherent barrier when applied to a bleeding point.
The aim of this trial is to study the use of PuraStat® in reducing the need for thermal
haemostasis during ESD.
Endoscopic submucosal dissection (ESD) is an endoscopic technique that involves the use of an
endoscopic knife to gently peel off a superficial neoplasia of any size in an en-bloc
fashion. It meets the principles of onco-surgery and is associated with excellent outcomes. A
difficulty however with the technique is control of bleeding during the procedure. The GI
mucosa is a vascular territory and the current method of managing intraprocedural bleeding is
electrocautery using either the endoscopic knife itself or the coag grasper. This introduces
a thermal injury to the bowel wall and carries the risk of causing a perforation or causing
pain. Furthermore, it requires precise targeting of the bleeding vessel. Practically this can
be challenging, particularly if the coag grasper is needed which is a bulky device and can be
difficult to apply precisely in some locations.
PuraStat® (3-D Matrix Ltd, Tokyo) is a liquid which is applied to a bleeding area which acts
rapidly to form a gel coat which induces haemostasis. This transparent adherent barrier
permits further endoscopic therapy to be performed. It can be applied in the general area of
bleeding and does not require precise application to the exact point of bleeding. It is
applied through a small catheter placed through the biopsy channel of the endoscope which can
be used in very small spaces.
PuraStat® is licensed as a CE marked device for use in exudative haemorrhage from vessels in
solid organs and within the GI tract. Given this indication, the role of PuraStat in ESD
needs to be explored as it could reduce the need for thermal haemostasis. This would be of
significant clinical benefit during ESD.
;