Injured Submucosal Arteries After CSP for 10-19 mm Nonpedunculated Colorectal Polyps.

Not Applicable

Completed

• Conditions: Colonic Polyp
• Interventions: Procedure: Active Comparator HS-EMR; Procedure: Experimental CSP

• Registration Number: NCT05930041
• Lead Sponsor: Showa Inan General Hospital

Brief Summary

Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized \<9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CSP of 10-19 mm nonpedunculated colorectal polyps.

Detailed Description

Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized \<9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CS-EMR of 10-19 mm nonpedunculated colorectal polyps. The primary outcome measure was the presence of injured submucosal arteries detected in the submucosal layer. The secondary outcomes included immediate bleeding and the frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy. Immediate bleeding was defined as spurting or oozing which continued for more than 30 seconds.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-06-25
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-07-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• at least one polyp sized 10-19 mm (Paris classification Is or IIa) revealed by endoscopic examination.

Exclusion Criteria

1. American Society of Anesthesiologists status class 3 or above
2. poor bowel preparation (Boston Bowel Preparation Scale <6 points)
3. endoscopic features indicating submucous infiltration or malignancy
4. oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
5. a history of colorectal resection
6. emergent colonoscopy (haemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients)
7. inflammatory bowel disease, familial polyposis and colorectal cancer
8. pregnancy or lactation
9. severe cardiopulmonary dysfunction, cirrhosis, chronic kidney disease, other malignant tumours or severe infectious diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-EMR	Active Comparator HS-EMR	-
CSP	Experimental CSP	-

Primary Outcome Measures

Name	Time	Method
the presence of injured submucosal arteries detected in the submucosal layer.	1 day	the presence of injured submucosal arteries detected in the submucosal layer.

Secondary Outcome Measures

Name	Time	Method
Delayed bleeding	14 days	The frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy.
Immediate bleedling	1 day	The frequency of Immediate bleeding which was defined as spurting or oozing which continued for more than 30 seconds.

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Nagano, Japan