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

Sponsor
Showa Inan General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05930041
Collaborator
(none)
124
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

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. Cold snare endoscopic mucosal resection (CS-EMR) combining CSP and submucosal injection was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CS-EMR 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Experimental CS-EMR
  • Procedure: Active Comparator HS-EMR
 N/A

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. Cold snare endoscopic mucosal resection (CS-EMR) combining CSP and submucosal injection was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CS-EMR 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 Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Presence of Injured Submucosal Arteries After Cold Snare Endoscopic Mucosal Resection (CS-EMR) is Lower Than That of Conventional Hot Snare Endoscopic Mucosal Resection (HS-EMR) for 10-19 mm Nonpedunculated Colorectal Polyps.
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CS-EMR

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

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

Outcome Measures

Primary Outcome Measures

  1. the presence of injured submucosal arteries detected in the submucosal layer. [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Showa Inan General Hospital Komagane Nagano Japan 399-4117

Sponsors and Collaborators

  • Showa Inan General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akira Horiuchi, Chief, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT05930041
Other Study ID Numbers:
  • CSEMR/HSEMR
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Polyps
Colonic Polyps

Study Results

No Results Posted as of Jul 6, 2023