This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps.
Subjects aged 18-75 years, irrespective of gender;
Flat sessile colorectal polyps confirmed by colonoscopy, classified as Paris classification 0-Is or 0-IIa, with a measured diameter ranging from 10 to 20 mm;
Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.
Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
Previous history of colorectal surgery;
Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
Parallel
Cold snare endoscopic mucosal resection (CS-EMR)
Procedure/SurgeryDuring CS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The polyp together with 1-2 mm of adjacent mucosa is subsequently tightly snared and mechanically transected.
Hot snare endoscopic mucosal resection (HS-EMR)
Procedure/SurgeryDuring HS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The snare is positioned around the lesion, and electrocautery is delivered via the electrosurgical generator for transection.
complete resection rate
All five biopsy specimens harvested from the resection margins after EMR resection yielded negative pathological findings. These five biopsy samples consisted of four specimens collected from the four quadrants of the resection wound margin and one specimen obtained from the wound base.
en bloc resection rate
The lesion was completely excised under endoscope and a single specimen was obtained.
Unresectable rate of CS-EMR
A resection procedure that needed high-frequency electric current.
Intraprocedural bleeding
Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention.
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
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Nanfang Hospital, Southern Medical University
Lead sponsor
Shunde First People's Hospital of Foshan
Collaborator
Jiangmen Central Hospital
Collaborator
ZhuHai Hospital
Collaborator
Longgang District People's Hospital of Shenzhen
Collaborator
Yangjiang People's Hospital
Collaborator
The Third People's Hospital of Huizhou
Collaborator
Longnan Traditional Chinese Medicine Hospital
Collaborator
Sihui Wanlong Hospital
Collaborator
Suixi People's Hospital of Zhanjiang
Collaborator
Guzhen People's Hospital of Zhongshan
Collaborator
Anyuan County People's Hospital of Ganzhou
Collaborator
Shaoguan First People's Hospital
Collaborator
Yangchun People's Hospital
Collaborator
ZhuZhou Central Hospital
Collaborator
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