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Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps (HSPvsHSPASI)

Primary Purpose

Polyp of Large Intestine

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
hot snare polypectomy
hot snare polypectomy after saline injection
Sponsored by
Bo-In Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyp of Large Intestine focused on measuring neoplastic colorectal polyp, hot snare polypectomy, hot snare polypectomy after saline injection

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over the age of 30
  • 5~10mm sized colorectal polyps
  • Informed consent

Exclusion Criteria:

  • Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
  • Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
  • ASA class III or more
  • Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Sites / Locations

  • Division of Gastroenterology; Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hot snare polypectomy

Hot snare polypectomy(saline injection)

Arm Description

Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique

Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique

Outcomes

Primary Outcome Measures

Complete Resection Rate
Complete resection was defined as the absence of residual polyp in the resection margin

Secondary Outcome Measures

Lateral Margin
Observation of maring on a recsected specimen

Full Information

First Posted
September 10, 2014
Last Updated
April 6, 2020
Sponsor
Bo-In Lee
Collaborators
St Vincent's Hospital, Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02239536
Brief Title
Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps
Acronym
HSPvsHSPASI
Official Title
Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo-In Lee
Collaborators
St Vincent's Hospital, Incheon St.Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Large Intestine
Keywords
neoplastic colorectal polyp, hot snare polypectomy, hot snare polypectomy after saline injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hot snare polypectomy
Arm Type
Experimental
Arm Description
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
Arm Title
Hot snare polypectomy(saline injection)
Arm Type
Experimental
Arm Description
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
Intervention Type
Procedure
Intervention Name(s)
hot snare polypectomy
Intervention Description
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
Intervention Type
Procedure
Intervention Name(s)
hot snare polypectomy after saline injection
Intervention Description
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
Primary Outcome Measure Information:
Title
Complete Resection Rate
Description
Complete resection was defined as the absence of residual polyp in the resection margin
Time Frame
2 weeks after
Secondary Outcome Measure Information:
Title
Lateral Margin
Description
Observation of maring on a recsected specimen
Time Frame
2 weeks after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 30 5~10mm sized colorectal polyps Informed consent Exclusion Criteria: Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis) Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy ASA class III or more Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo-In Lee
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology; Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29250580
Citation
Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27.
Results Reference
background
PubMed Identifier
25708763
Citation
Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
Results Reference
background
PubMed Identifier
28970290
Citation
Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.
Results Reference
background
PubMed Identifier
32989532
Citation
Kim SJ, Lee BI, Jung ES, Kim JS, Jun SY, Kim W, Ham H, Kim M, Lee SH, Lee HH, Park JM, Choi MG. Hot snare polypectomy versus endoscopic mucosal resection for small colorectal polyps: a randomized controlled trial. Surg Endosc. 2021 Sep;35(9):5096-5103. doi: 10.1007/s00464-020-07994-7. Epub 2020 Sep 28.
Results Reference
derived

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Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps

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