The goal of this clinical trial is to learn whether a new endoscopic device called the Speedboat works as well or better than the standard needle knife for removing large colonic nonpedunculated polyps. The study will also evaluate the safety of the Speedboat device.
The main aims of the study are:
* To compare the resection speed of colorectal endoscopic submucosal dissection (ESD) using the Speedboat device versus the standard needle knife. * To compare the en bloc resection rate and curative (R0) resection rate between the two techniques. * To evaluate the safety of using the Speedboat device compared with the needle knife in colorectal ESD.
What will happen in this study Adults aged 18 years or older who have a large, flat colorectal polyp (greater than 20 mm) that cannot be safely removed with standard snare polypectomy may take part.
Participants will be randomly assigned (like flipping a coin) to one of two groups:
* Speedboat group: The lesion will be removed using the Speedboat device, which combines injection, cutting, and bleeding control in one tool. * Needle knife group: The lesion will be removed using the standard needle knife and other separate tools for injection and hemostasis.
What participants will do Stay one night in the hospital before the colonoscopy for bowel preparation. Undergo colonoscopy and lesion removal under anesthesia. Have blood tests and monitoring for one day after the procedure. Be followed for two weeks to check for any complications. Have a follow-up colonoscopy 6-12 months later, depending on pathology results.
Where and how the study will be done
The study will take place at five hospitals in Thailand:
Faculty of Medicine Siriraj Hospital, Mahidol University King Chulalongkorn Memorial Hospital Rajavithi Hospital National Cancer Institute of Thailand Phra Nakhon Si Ayutthaya Hospital
About 80 participants will join the study. All procedures will be performed by experienced endoscopists who have performed at least 50 colorectal ESD cases.
Age 18 or above with large non-pedunculated colorectal polyp size > 20 mm. in which 1st endoscopist decided that lesion cannot be resected with endoscopic mucosal resection to achieve en bloc resection
Patients who have coagulopathy which is contraindicated for colonoscopy and polypectomy (Prothrombin time > 3-second ULN, INR > 1.5, Platelet < 50,000)
The non-pedunculated lesion that was recurrence from the previous polypectomy or ESD
Suspected deep submucosal invasion using image-enhanced endoscopy by expert endoscopist
Patients who were diagnosed with inflammatory bowel disease
Parallel
Speedboat
DeviceESD procedure was performed using conventional, pocket-creation, or tunnel methods, depending on the endoscopist's decision. Speedboat group, any of the 2.8, 3.2, or 3.7 mm Speedboat devices is used in all procedure steps, including submucosal injection, mucosal incision, submucosal dissection, and vessel coagulation. A 25G injection needle can be used to initiate the submucosal injection in the case of using a 2.8 mm Speedboat device. If any devices other than Speedboat were used in the procedure, those should be recorded.
Needle knife
DeviceESD procedure was performed using conventional, pocket-creation, or tunnel methods, depending on the endoscopist's decision. In needle knife gropu, a 25G injection needle is used in the initial submucosal injection step. A 1.5 mm needle knife is used for mucosal incision, submucosal dissection, and additional submucosal injection. Coagrasper is used for coagulating submucosal vessels. All used devices were recorded.
The resection speed of colorectal endoscopic submucosal dissection using a Speedboat device compared with the standard needle knife.
Resection speed was calculated using the following formulation. Resection speed = ((specimen diameter in the long axis, mm) x (specimen diameter in the short axis, mm) x 3.14 x 0.25) /procedure time (min). In case of patients with multiple lesions, the biggest lesion will be included in the study
The en bloc resection rate and curative resection(R0) rate between using Speedboat and needle knife in colorectal ESD
En bloc resection is defined as the resection of the total lesion in one piece. Curative resection(R0) is defined as all margins of the resected lesion that are not involved by adenoma, the tumor does not invade beyond superficial submucosa, no lympho-vascular invasion, no high-grade tumor budding, and no evidence of poorly differentiated carcinoma.
The intraprocedural and postprocedural complications of using Speedboat and needle knife in colorectal ESD.
Complications include delayed bleeding, intraprocedural and delayed perforation, and post-ESD coagulation syndrome.
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