Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps

Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps: A Multicenter, Prospective, Randomized, Non-Inferiority Clinical Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Colorectal Polyps; Endoscopic Mucosal Resection
• Intervention / Treatment: Procedure: Cold snare endoscopic mucosal resection (CS-EMR); Procedure: Hot snare endoscopic mucosal resection (HS-EMR)

• Study Type: Interventional
• Enrollment (Estimated): 968
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bitao Lin, MD; Phone Number: +86 137-2532-1385; Email: linbitao1996@163.com
• Study Contact Backup: Name: Zelong Han, MD; Phone Number: +86 189-2506-1960; Email: hanzelong2025@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects aged 18-75 years, irrespective of gender;
2. 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;
3. Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.

Exclusion Criteria:

1. Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
2. Previous history of colorectal surgery;
3. Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
4. Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
5. Known coagulation disorders or bleeding diathesis;
6. Pregnant or breastfeeding women;
7. Patients complicated with malignant tumors, severe cardiovascular and cerebrovascular diseases, liver cirrhosis, chronic kidney disease, or other severe comorbidities that preclude tolerance to endoscopic resection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold snare endoscopic mucosal resection (CS-EMR); Eligible colorectal polyps measuring 10-20 mm will be resected using CS-EMR.	Procedure: Cold snare endoscopic mucosal resection (CS-EMR); 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.
Active Comparator: Hot snare endoscopic mucosal resection (HS-EMR); Eligible colorectal polyps measuring 10-20 mm will be resected using HS-EMR.	Procedure: Hot snare endoscopic mucosal resection (HS-EMR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed perforation	Any perforation within 14 days	Within 14 days
en bloc resection rate	The lesion was completely excised under endoscope and a single specimen was obtained.	Within one days
Unresectable rate of CS-EMR	A resection procedure that needed high-frequency electric current.	Within one day
Intraprocedural bleeding	Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention.	Within one day
Intraprocedural perforation	Endoscopic observation of perforation requiring sealing with clips	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	Within one day
Delayed bleeding	haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days.	Within 14 days
Number of clips used	The number of clips used for each resected polyp	Within one day

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Collaborators: ZhuZhou Central Hospital; ZhuHai Hospital; Jiangmen Central Hospital; Yangjiang People's Hospital; Shaoguan First People's Hospital; Longgang District People's Hospital of Shenzhen; Yangchun People's Hospital; The Third People's Hospital of Huizhou; Shunde First People's Hospital of Foshan; Sihui Wanlong Hospital; Suixi People's Hospital of Zhanjiang; Longnan Traditional Chinese Medicine Hospital; Guzhen People's Hospital of Zhongshan; Anyuan County People's Hospital of Ganzhou

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2026-545

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No