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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
968
During 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.
During 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.
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 one days
Unresectable rate of CS-EMR
A resection procedure that needed high-frequency electric current.
Time frame: Within one day
Intraprocedural bleeding
Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention.
Time frame: Within one day
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
Time frame: Within one day
Procedural time
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Time frame: Within one day
Delayed bleeding
haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days.
Time frame: Within 14 days
Delayed perforation
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Any perforation within 14 days
Time frame: Within 14 days
Number of clips used
The number of clips used for each resected polyp
Time frame: Within one day