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Completed

NCT Number: NCT05930041

Injured Submucosal Arteries After CSP 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Experimental CSP

Procedure

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

Active Comparator HS-EMR

Procedure

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

Primary outcomes

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

    Time frame: 1 day

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

Secondary outcomes

  1. Delayed bleeding

    Time frame: 14 days

    The frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy.

  2. Immediate bleedling

    Time frame: 1 day

    The frequency of Immediate bleeding which was defined as spurting or oozing which continued for more than 30 seconds.

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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