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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05545787
Other study ID # K2203
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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