Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

May 28, 2015 updated by: LEUNG Wai Keung, The University of Hong Kong

Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy.

Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been developed to improve colonic polyp detection. However, it remains controversial whether the previous version of NBI helps to improve colonic polyp detection. The new generation colonoscope is equipped with high definition and improved narrow band imaging (NBI) which gives at least twice the viewable distance and contrast. The images obtained are far brighter with better resolution than the previous version. It however remains to be determined whether this enhanced imaging technique could help to improve colonic polyps detection.

Hypothesis:

The new generation NBI increases the detection rate of proximal serrated polyps and reduces the missed rate of all colorectal polyps.

Aims:

  • To determine whether the new generation NBI improve the detection rate of proximal serrated polyps.
  • To determine whether the new generation NBI improve the detection rate of all colorectal adenoma and polyps.
  • To determine whether the new generation NBI reduce the miss rate of colorectal adenoma and polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design:

Prospective randomized trial

Inclusion:

• All patients scheduled to have screening or scheduled colonoscopy

Exclusion:

  • History of Crohn's or ulcerative colitis
  • Surveillance for known polyposis syndrome (FAP or HNPCC)
  • Previous colonic resection (except appendectomy)
  • Refused consent
  • Deranged coagulation profile that preclude polypectomy

Study Type

Observational

Enrollment (Actual)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled to have colonoscopy for screening, surveillance or symptoms

Description

Inclusion Criteria:

  • All patients scheduled to have colonoscopy

Exclusion Criteria:

  • History of Crohn's or ulcerative colitis
  • Surveillance for known polyposis syndrome (FAP or HNPCC)
  • Previous colonic resection (except appendectomy)
  • Refused consent
  • Deranged coagulation profile that preclude polypectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Narrow band imaging
Colonoscopy with new narrow band imaging
Other: Narrow band imaging
Colonoscopy with new narrow band imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of proximal serrated polyp
Time Frame: During colonoscopy
No. of patients with proximal serrated polyps
During colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missed rate for proximal serrated polyps
Time Frame: During colonoscopy
Missing rate for proximal serrated polyps
During colonoscopy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: during colonoscopy
No. of patients with adenoma detected
during colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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