This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
During CS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The polyp and 1-2mm of surrounding mucosa will then be closely snared and transected mechanically.
During HS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The snare will be placed around the lesion, and then cautery will be applied using the electrosurgical generator.
Beijing Dongcheng District First People's Hospital
Beijing, Beijing Municipality, China
Emergency General Hospital
Beijing, Beijing Municipality, China
Complete resection rate
The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.
Time frame: Within 14 days
En-bloc resection rate
The lesion was completely excised under endoscope and a single specimen was obtained.
Time frame: Within 1 day
Intraprocedural bleeding
Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Time frame: Within 1 day
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
Time frame: Within 1 day
Delayed bleeding
Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Time frame: Within 14 days
Delayed perforation
Any perforation within 14 days
Time frame: Within 14 days
Number of clips used
The number of endoscopic clips used for each resected polyp
Time frame: Within 1 day
Resection time
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Beijing Sixth Hospital
Beijing, Beijing Municipality, China
Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Beijing Fangshan District Liangxiang Hospital
Beijing, Beijing Municipality, China
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
...and 5 more locations
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Time frame: Within 1 day
Total cost
Total cost including both treatment cost and material cost for polyp resection
Time frame: Within 1 day