Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection

Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Polyp; Colon Neoplasia
• Intervention / Treatment: Device: Colorectal ESD with SpydrBlade Flex

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hon Chi Yip, MBChB; Phone Number: 35052627; Email: hcyip@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic submucosal dissection with SpydrBlade Flex; This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife

Device: Colorectal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En-bloc resection rate	Defined by complete macroscopic resection of the target neoplasia in one single specimen	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	Defined by histologically margin negative resection (Both horizontal and vertical margins)	30 days
Curative resection rate	Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines	30 days
Adverse event rate	Overall adverse event rate, according to ASGE lexicon	30 days
Rate of adverse event - hemorrhage	Rate of intraprocedural and post procedural delayed hemorrhage	30 days
Rate of adverse event - perforation	Rate of intraprocedural and post procedural delayed perforation	30 days
Rate of adverse event - post-ESD coagulation syndrome	Defined by post-procedural abdominal pain and systemic inflammatory response	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Duration of ESD	1 day
Device dysfunction	Failure of device to continue the procedure	1 day
Need for change to other device	Rate of changing to other ESD knife	1 day

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Hon Chi Yip, MBChB, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): December 8, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection
• Additional Relevant MeSH Terms: Neoplasms by Site; Pathological Conditions, Anatomical; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Polyps; Intestinal Polyps; Neoplasms; Colonic Neoplasms; Colonic Polyps
• Other Study ID Numbers: CRE-2024.495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No