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

NCT05930041 | Completed DMC

• 1 other identifier: CSP/HSEMR
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• the presence of injured submucosal arteries detected in the submucosal layer.

  the presence of injured submucosal arteries detected in the submucosal layer.

  1 day

Secondary Outcomes (2)

• Delayed bleeding

  14 days

• Immediate bleedling

  1 day

Study Arms (2)

CSP

EXPERIMENTAL

Procedure: Experimental CSP

HS-EMR

ACTIVE COMPARATOR

Procedure: Active Comparator HS-EMR

Interventions

Experimental CSP PROCEDURE

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

CSP

Active Comparator HS-EMR PROCEDURE

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

HS-EMR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• American Society of Anesthesiologists status class 3 or above
• poor bowel preparation (Boston Bowel Preparation Scale \<6 points)
• endoscopic features indicating submucous infiltration or malignancy
• oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
• a history of colorectal resection
• emergent colonoscopy (haemodynamic 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, cirrhosis, chronic kidney disease, other malignant tumours or severe infectious diseases.

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

Related Publications (1)

• 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.

  PMID: 40104570 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)