PuraStat® for Bleed Control in Endoscopic Submucosal Dissection (v1.0)
Research type
Research Study
Full title
Randomised Controlled Trial comparing PuraStat® with Standard Therapy for Haemostasis Control in Endoscopic Submucosal Dissection
IRAS ID
192912
Contact name
Pradeep Bhandari
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Endoscopic submucosal dissection (ESD) is a technique used to treat early cancer within the gastrointestinal tract. An endoscopic knife is used to gently peel away the entire superficial cancer and is associated with excellent outcomes and a very low risk of cancer recurrence. A difficulty, however, with the technique is the control of bleeding requiring precise targeting during the procedure. The gastrointestinal tract and its lining are supplied by lots of blood vessels and the current method of managing bleeding is using heat therapy delivered through the endoscopic knife or a device known as the coag grasper. Precise targeting may be difficult and the resulting heat damage carries a risk of a tear in the gastrointestinal lining. \n\nPuraStat® is a synthetic liquid applied through the endoscope to the bleeding area. It forms a transparent gel coat that acts as a barrier to prevent further bleeding and allows the procedure to continue. It may also promote wound healing and has been used to control bleeding in the field of cardiothoracic surgery. We wish to study the role of PuraStat® in controlling bleeding and reducing heat use during ESD. \n\nPatients undergoing ESD for early cancerous lesions in the gullet and bowel will be included in the study. Eligible patients who have agreed to take part will be randomly allocated to receive either PuraStat® (and heat therapy) or standard heat therapy alone to control bleeding. We will measure the number of times heat therapy is used in both groups of patients to ascertain if there has been a reduction in heat therapy use in the PuraStat® group. We will also record complication rates and the time taken for procedures in each group. A follow up endoscopy will be performed in 6 weeks to assess wound healing.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0020
Date of REC Opinion
23 Jan 2016
REC opinion
Favourable Opinion