NCT02239536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

September 10, 2014

Results QC Date

July 17, 2019

Last Update Submit

April 6, 2020

Conditions

Keywords

neoplastic colorectal polyphot snare polypectomyhot snare polypectomy after saline injection

Outcome Measures

Primary Outcomes (1)

  • Complete Resection Rate

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

    2 weeks after

Secondary Outcomes (1)

  • Lateral Margin

    2 weeks after

Study Arms (2)

Hot snare polypectomy

EXPERIMENTAL

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

Procedure: hot snare polypectomy

Hot snare polypectomy(saline injection)

EXPERIMENTAL

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

Procedure: hot snare polypectomy after saline injection

Interventions

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

Hot snare polypectomy

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

Hot snare polypectomy(saline injection)

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, 137-701, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 29250580BACKGROUND
  • 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.

    PMID: 25708763BACKGROUND
  • 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.

    PMID: 28970290BACKGROUND
  • 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 Point of Contact

Title
Bo-In Lee
Organization
Seoul ST. Mary's hospital

Study Officials

  • Bo-In Lee

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 12, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

April 14, 2020

Results First Posted

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations