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

Not Applicable

Recruiting

• Conditions: Colorectal Polyp
• Interventions: Procedure: Hot snare endoscopic mucosal resection; Procedure: Cold snare endoscopic mucosal resection

• Registration Number: NCT05545787
• Lead Sponsor: Qingwei Jiang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Study Start: 2022-10-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hot snare endoscopic mucosal resection (HS-EMR)	Hot snare endoscopic mucosal resection	Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR
Cold snare endoscopic mucosal resection (CS-EMR)	Cold snare endoscopic mucosal resection	Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR

Primary Outcome Measures

Name	Time	Method
Complete resection rate	Within 14 days	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.

Secondary Outcome Measures

Name	Time	Method
En-bloc resection rate	Within 1 day	The lesion was completely excised under endoscope and a single specimen was obtained.
Intraprocedural bleeding	Within 1 day	Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Intraprocedural perforation	Within 1 day	Endoscopic observation of perforation requiring sealing with clips
Delayed bleeding	Within 14 days	Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Delayed perforation	Within 14 days	Any perforation within 14 days
Number of clips used	Within 1 day	The number of endoscopic clips used for each resected polyp
Total cost	Within 1 day	Total cost including both treatment cost and material cost for polyp resection
Resection time	Within 1 day	The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp

Trial Locations

Locations (3)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

Seventh Medical Center, General Hospital of the Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China