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
1 other identifier
interventional
216
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2026
CompletedMay 1, 2026
April 1, 2026
3.5 years
September 15, 2022
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
En-bloc resection rate
Within 1 day
Intraprocedural bleeding
Within 1 day
Intraprocedural perforation
Within 1 day
Delayed bleeding
Within 14 days
Delayed perforation
Within 14 days
- +3 more secondary outcomes
Study Arms (2)
Cold snare endoscopic mucosal resection (CS-EMR)
EXPERIMENTALEligible colorectal polyps sized 10-19mm will be resected by CS-EMR
Hot snare endoscopic mucosal resection (HS-EMR)
EXPERIMENTALEligible colorectal polyps sized 10-19mm will be resected by HS-EMR
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qingwei Jianglead
Study Sites (15)
Beijing Dongcheng District First People's Hospital
Beijing, Beijing Municipality, 100010, China
Emergency General Hospital
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
Related Publications (1)
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.
PMID: 37217262DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Qingwei Jiang, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- attending physician
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 19, 2022
Study Start
October 14, 2022
Primary Completion
April 15, 2026
Study Completion
April 15, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04