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ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps. — ORISE  

Colorectal Polyp Clinical Trial

Official title:
ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

Clinical Trial Summary

Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

Clinical Trial Description

Endoscopic resection of large colonic polyps is preferred over Surgical resections due to lower morbidity and preservation of the colon and its functions. The use of submucosal injection is essential for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases. A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time. Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect. Multicentre prospective observational cohort study Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness & safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE). Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04886609
Study type Observational [Patient Registry]
Source Portsmouth Hospitals NHS Trust
Contact Pradeep Bhandari
Phone 02392 286000
Email pradeep.bhandari@porthosp.nhs.uk
Status Recruiting
Phase
Start date March 25, 2021
Completion date April 24, 2023
View Details
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