Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps

A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps

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 Overview

• Status: Completed
• Conditions: Colorectal Polyp
• Intervention / Treatment: Procedure: Cold snare endoscopic mucosal resection; Procedure: Hot snare endoscopic mucosal resection

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100028
      • Emergency General Hospital
    • Beijing, Beijing Municipality, China, 100010
      • Beijing Dongcheng District First People's Hospital
    • Beijing, Beijing Municipality, China, 100191
      • Beijing Sixth Hospital
    • Beijing, Beijing Municipality, China, 100700
      • Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
    • Beijing, Beijing Municipality, China, 102401
      • Beijing Fangshan District Liangxiang Hospital
    • Beijing, Beijing Municipality, China, 102600
      • Beijing Daxing District People'S Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Shandong
    • Qingdao, Shandong, China, 266005
      • The Affiliated Hospital of Qingdao University
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Longquan Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610083
      • PLA Western Theater General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-80 years of age;
• undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
• volunteer to participate in this study and sign informed consent;
• at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) status class 3 or above;
• poor bowel preparation (Boston bowel preparation scale < 6 points);
• known or endoscopic features indicating the submucous infiltration or malignancy;
• oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets<50000 cells/mm3 or INR>1.5);
• a history of colorectal resection;
• emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients);
• inflammatory bowel disease, familial polyposis, and colorectal cancer;
• pregnancy or lactation;
• severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold snare endoscopic mucosal resection (CS-EMR); Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR	Procedure: Cold snare endoscopic mucosal resection; 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.
Experimental: Hot snare endoscopic mucosal resection (HS-EMR); Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR	Procedure: Hot snare endoscopic mucosal resection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Qingwei Jiang
• Investigators: Principal Investigator: Qingwei Jiang, MD, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: K2203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No