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

NCT ID: NCT05930041

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Colonic Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CSP

Group Type: EXPERIMENTAL

Experimental CSP

Intervention Type: PROCEDURE

Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.

HS-EMR

Group Type: ACTIVE_COMPARATOR

Active Comparator HS-EMR

Intervention Type: PROCEDURE

Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.

Interventions

Experimental CSP

Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.

Intervention Type: PROCEDURE

Active Comparator HS-EMR

Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Showa Inan General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Akira Horiuchi

Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Showa Inan General Hospital

Komagane, Nagano, Japan

Countries

Japan

References

Kurasawa S, Horiuchi I, Kajiyama M, Kitahara H, Terashima T, Horiuchi A. Injured submucosal arteries following cold snare polypectomy are significantly fewer versus those after endoscopic mucosal resection for 10-19-mm nonpedunculated colorectal polyps. DEN Open. 2025 Mar 18;5(1):e70099. doi: 10.1002/deo2.70099. eCollection 2025 Apr.

Reference Type: DERIVED

PMID: 40104570 (View on PubMed)

Other Identifiers

CSP/HSEMR

Identifier Type: -

Identifier Source: org_study_id