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

Colonic Polyp Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930041
• Other study ID #: CSP/HSEMR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Showa Inan General Hospital
• Contact: Akira Horiuchi, MD
• Phone: 81265822121
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Procedure:
• Experimental CSP
Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.
• Active Comparator HS-EMR
Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

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