NCT01646242

Brief Summary

Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_4

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

July 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

July 16, 2012

Last Update Submit

October 13, 2014

Conditions

Polyp of Large Intestine

Outcome Measures

Primary Outcomes (1)

  • Complete histologic polyp eradication rate

    2 weeks

Secondary Outcomes (4)

  • Time taken for polypectomy (complete visual eradication of each polyp)

    2 weeks

  • Successful tissue retrieval rate of removed tissues

    2 weeks

  • Rates of adverse events

    4 weeks

  • Complete visual polyp eradication rate

    2 weeks

Study Arms (2)

Cold snare polypectomy

EXPERIMENTAL
Procedure: removal of eligible polyps using cold snare polypectomy technique

Double biopsy polypectomy

EXPERIMENTAL
Procedure: removal of eligible polyps using double biopsy technique

Interventions

removal of eligible polyps using cold snare polypectomy techniquePROCEDURE

Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery

Cold snare polypectomy
removal of eligible polyps using double biopsy techniquePROCEDURE

Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)

Double biopsy polypectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 20
  • Informed consent

You may not qualify if:

  • Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
  • Known existing bleeding tendency (thrombocytopenia or prolonged INR)
  • Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
  • ASA class III or more
  • Pregnancy
  • 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)

Kyunghee University Medical Center

Seoul, 130-702, South Korea

Location

Related Publications (4)

  • Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.

    PMID: 14994108BACKGROUND

  • Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.

    PMID: 22196811BACKGROUND

  • Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16.

    PMID: 21412704BACKGROUND

  • Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.

    PMID: 24042189DERIVED

Study Officials

  • Chang Kyun Lee, MD, PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

KR(1)