Colon Neoplasia, Colon Polyp
Conditions
Keywords
Endoscopic submucosal dissection
Brief summary
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.
Detailed description
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.
Interventions
DEVICEColorectal ESD with SpydrBlade Flex
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patient (age ≥18 and ≤80 years-old) * Capability of understanding and complying with the study requirements, including signing the informed consent form. * Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).
Exclusion criteria
* Patients unable or unwilling to provide consent. * Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer. * Patients with lesions involving the appendiceal orifice or ileocaecal valve. * Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure. * Poor performance status (Eastern Cooperation Oncology Group performance status ≥3). * Pregnant women or those planning pregnancy or breastfeeding women. * Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| En-bloc resection rate | 30 days | Defined by complete macroscopic resection of the target neoplasia in one single specimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 30 days | Overall adverse event rate, according to ASGE lexicon |
| Rate of adverse event - hemorrhage | 30 days | Rate of intraprocedural and post procedural delayed hemorrhage |
| Rate of adverse event - perforation | 30 days | Rate of intraprocedural and post procedural delayed perforation |
| Rate of adverse event - post-ESD coagulation syndrome | 30 days | Defined by post-procedural abdominal pain and systemic inflammatory response |
| R0 resection rate | 30 days | Defined by histologically margin negative resection (Both horizontal and vertical margins) |
| Curative resection rate | 30 days | Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for change to other device | 1 day | Rate of changing to other ESD knife |
| Procedure time | 1 day | Duration of ESD |
| Device dysfunction | 1 day | Failure of device to continue the procedure |
Countries
Hong Kong
Contacts
Primary ContactHon Chi Yip, MBChB
Outcome results
None listed