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

Colorectal Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545787
• Other study ID #: K2203
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Qingwei Jiang, MD
• Phone: 8610-69151591
• Email: flyerj[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Seventh Medical Center, General Hospital of the Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qingwei Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	En-bloc resection rate	The lesion was completely excised under endoscope and a single specimen was obtained.	Within 1 day
Secondary	Intraprocedural bleeding	Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s	Within 1 day
Secondary	Intraprocedural perforation	Endoscopic observation of perforation requiring sealing with clips	Within 1 day
Secondary	Delayed bleeding	Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days	Within 14 days
Secondary	Delayed perforation	Any perforation within 14 days	Within 14 days
Secondary	Number of clips used	The number of endoscopic clips used for each resected polyp	Within 1 day
Secondary	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
Secondary	Total cost	Total cost including both treatment cost and material cost for polyp resection	Within 1 day