ORISE Gel

  • Research type

    Research Study

  • Full title

    ORISE Study: Evaluation of novel injecting solution (ORISE) during endoscopic resection of colorectal polyps.

  • IRAS ID

    275810

  • Contact name

    Dr Alice Mortlock

  • Contact email

    alice.mortlock@porthosp.nhs.uk

  • Sponsor organisation

    Portsmouth Hospitals University NHS Trust

  • Clinicaltrials.gov Identifier

    NCT04886609

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Bowel cancer is the third most common cancer in the UK. It develops through growths in the bowel called polyps. With recent advancements in technology, early cancers can be found and removed through endoscopic techniques and hence avoiding surgery. The current techniques in use are Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). Both the above procedures require an injection of a fluid to the base of the lesion which lifts it up hence leading to a safer resection (avoids making holes in the bowel- perforation). The most common injection used currently is a mixture of saline, adrenaline and a dye. Although cheap and readily available, this solution tends to dissipate away from the tissue very quickly, hence potentiating the need of multiple injections during the procedure. This not only increases the time of the procedure, but also impairs the field of endoscopic vision and increases the rate of complication.

    ORISE gel is a new injecting solution which is poloxamer based. The advantage of this solution is that it lasts in the tissue for much longer than saline, hence reducing number of injections ( possible one injection for the entire procedure) This reduces the length of the procedure and the complications associated with it.

    We aim to study the efficacy and feasibility of ORISE gel in endoscopic resection of lower gastrointestinal polyps.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    20/YH/0343

  • Date of REC Opinion

    28 Jan 2021

  • REC opinion

    Further Information Favourable Opinion