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

Primary Purpose

Colonic Polyp

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Experimental CSP
Active Comparator HS-EMR
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Showa Inan General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CSP

HS-EMR

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delayed bleeding
The frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy.
Immediate bleedling
The frequency of Immediate bleeding which was defined as spurting or oozing which continued for more than 30 seconds.

Full Information

First Posted
June 25, 2023
Last Updated
August 13, 2023
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05930041
Brief Title
Injured Submucosal Arteries After CSP for 10-19 mm Nonpedunculated Colorectal Polyps.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSP
Arm Type
Experimental
Arm Title
HS-EMR
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Experimental CSP
Intervention Description
Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.
Intervention Type
Procedure
Intervention Name(s)
Active Comparator HS-EMR
Intervention Description
Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.
Primary Outcome Measure Information:
Title
the presence of injured submucosal arteries detected in the submucosal layer.
Description
the presence of injured submucosal arteries detected in the submucosal layer.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Delayed bleeding
Description
The frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy.
Time Frame
14 days
Title
Immediate bleedling
Description
The frequency of Immediate bleeding which was defined as spurting or oozing which continued for more than 30 seconds.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akira Horiuchi, MD
Phone
81265822121
Ext
3012
Email
horiuchi.akira@sihp.jp
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamaguchi Yukari

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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