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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold snare endoscopic mucosal resection (CS-EMR) | Experimental | Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR |
|
| Hot snare endoscopic mucosal resection (HS-EMR) | Experimental | Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold snare endoscopic mucosal resection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| En-bloc resection rate | The lesion was completely excised under endoscope and a single specimen was obtained. | Within 1 day |
| Intraprocedural bleeding | Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingwei Jiang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Dongcheng District First People's Hospital | Beijing | Beijing Municipality | 100010 | China | ||
| Emergency General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37217262 | Derived | Jiang Q, Yan X, Wang D, Zhang S, Zhang Y, Feng Y, Yang A, Wu D. Endoscopic mucosal resection using cold snare versus hot snare in treatment for 10-19 mm non-pedunculated colorectal polyps: protocol of a non-inferiority randomised controlled study. BMJ Open. 2023 May 22;13(5):e070321. doi: 10.1136/bmjopen-2022-070321. |
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|
| Hot snare endoscopic mucosal resection | Procedure | 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. |
|
| Within 1 day |
| Intraprocedural perforation | Endoscopic observation of perforation requiring sealing with clips | Within 1 day |
| Delayed bleeding | Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days | Within 14 days |
| Delayed perforation | Any perforation within 14 days | Within 14 days |
| Number of clips used | The number of endoscopic clips used for each resected polyp | Within 1 day |
| Resection time | The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp | Within 1 day |
| Total cost | Total cost including both treatment cost and material cost for polyp resection | Within 1 day |
| Beijing |
| Beijing Municipality |
| 100028 |
| China |
| Beijing Sixth Hospital | Beijing | Beijing Municipality | 100191 | China |
| Seventh Medical Center, General Hospital of the Chinese People's Liberation Army | Beijing | Beijing Municipality | 100700 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 102218 | China |
| Beijing Fangshan District Liangxiang Hospital | Beijing | Beijing Municipality | 102401 | China |
| Beijing Daxing District People's Hospital | Beijing | Beijing Municipality | 102600 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266005 | China |
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| West China Longquan Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| PLA Western Theater General Hospital | Chengdu | Sichuan | 610083 | China |