The Efficacy and Safety of the SB Knife Jr. for colorectal ESD
Research type
Research Study
Full title
The Efficacy and Safety of Stag Beetle Knife Junior for colorectal endoscopic submucosal resection (ESD)
IRAS ID
255916
Contact name
Noor Mohammed
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This is an international multicentre prospective study looking at the safety and short and long-term outcomes using the Stag Beetle (SB) knife Jr. for colorectal endoscopic submucosal resection (ESD). ESD is a procedure that is used to resect large colorectal neoplasms (polyps) via a colonoscope. It allows the best opportunity to resect polyps in one piece (en bloc), allowing histological confirmation of resection completeness and is associated with reduced neoplastic recurrence at the resection site. ESD is now an established practice within the UK and worldwide, performed by advanced therapeutic endoscopists trained in this procedure.
Conventional ESD devices are used without fixing to the target, creating a potential risk of unexpected incision and perforation of the colorectal wall. The SB knife Jr. is designed to grasp and cut tissue by using a focused current
applied through insulated electrodes such that only the tissue grasped within the electrodes is cauterised. The SB knife Jr. has already been shown to be efficient and safe, associated with favourable short- and long-term outcomes in a Japanese single-centre prospective study. This prospective study will be performed at three UK sites: Dudley Group NHS Foundation Trust, Nottingham University Hospitals and Leeds Teaching Hospitals NHS Trusts. The procedures will be performed by one advanced therapeutic endoscopist at each site: Prof Sauid Ishaq (Dudley), Prof Adolfo Parra-Blanco (Nottingham) and Dr Noor Mohammed (Leeds), all competent in this procedure.
This multicentre international study will enrol 400 patients. We will approach the patients scheduled to undergo this procedure to request their permission to collect their clinical data relating to the intervention for a period of five years.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0273
Date of REC Opinion
18 Aug 2020
REC opinion
Further Information Favourable Opinion