This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.
This is a prospective study with the following study Objectives: 1. To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD. 2. To assess the impact of the procedure on patient recovery time and postoperative adverse event. This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The allocated intervention would be performed under sedation or monitored anaesthesia by experienced endoscopists with at least 50 case experience of colon ESD. Colon ESD procedure would be performed as per described in the literature. After submucosal injection of solution to create a cushion, mucosal incision and submucosal dissection would be performed with the SydrBlade Flex. Submucosal plane dissection will be performed using the SpydrBlade Flex (BRF, cutting frequency 400kHz, power setting 35W). The exact resection strategy would be according to the endoscopists' preference, including different adjunctive techniques such as countertraction, tunnelling or pocket creation method. Upon completion of ESD, the resultant mucosal defect would be examined for any perforation or bleeding.
The Chinese University of Hong Kong
Hong Kong, Hong Kong
En-bloc resection rate
Defined by complete macroscopic resection of the target neoplasia in one single specimen
Time frame: 30 days
R0 resection rate
Defined by histologically margin negative resection (Both horizontal and vertical margins)
Time frame: 30 days
Curative resection rate
Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines
Time frame: 30 days
Adverse event rate
Overall adverse event rate, according to ASGE lexicon
Time frame: 30 days
Rate of adverse event - hemorrhage
Rate of intraprocedural and post procedural delayed hemorrhage
Time frame: 30 days
Rate of adverse event - perforation
Rate of intraprocedural and post procedural delayed perforation
Time frame: 30 days
Rate of adverse event - post-ESD coagulation syndrome
Defined by post-procedural abdominal pain and systemic inflammatory response
Time frame: 30 days
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