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

The Presence of Injured Submucosal Arteries After Cold Snare Polypectomy(CSP) is Lower Than That of Conventional Hot Snare Endoscopic Mucosal Resection (HS-EMR) for 10-19 mm Nonpedunculated Colorectal Polyps.

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Procedure: Active Comparator HS-EMR; Procedure: Experimental CSP

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nagano
    • Komagane, Nagano, Japan, 399-4117
      • Showa Inan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HS-EMR	Procedure: Active Comparator HS-EMR; Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.
Experimental: CSP	Procedure: Experimental CSP; Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: CSP/HSEMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No