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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Qingwei Jiang |
China,
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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