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

NCT ID: NCT02239536

Last Updated: 2020-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Polyp of Large Intestine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hot snare polypectomy

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

Group Type EXPERIMENTAL

hot snare polypectomy

Intervention Type PROCEDURE

hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps

Hot snare polypectomy(saline injection)

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

Group Type EXPERIMENTAL

hot snare polypectomy after saline injection

Intervention Type PROCEDURE

hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps

Interventions

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hot snare polypectomy

hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps

Intervention Type PROCEDURE

hot snare polypectomy after saline injection

hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Vincent's Hospital

OTHER

Sponsor Role collaborator

Incheon St.Mary's Hospital

OTHER

Sponsor Role collaborator

Bo-In Lee

OTHER

Sponsor Role lead

Responsible Party

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Bo-In Lee

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bo-In Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 29250580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25708763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28970290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32989532 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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XC14TIMI0039K

Identifier Type: -

Identifier Source: org_study_id

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