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Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01725321
First received: November 8, 2012
Last updated: December 18, 2013
Last verified: December 2013
History of Changes
  Purpose

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.

Condition Intervention
Colonic Neoplasm
 Other: Narrow band imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Detection rate of proximal serrated polyp [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]
    No. of patients with proximal serrated polyps


Secondary Outcome Measures:
  • Missed rate for proximal serrated polyps [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]
    Missing rate for proximal serrated polyps


Other Outcome Measures:
  • Adenoma detection rate [ Time Frame: during colonoscopy ] [ Designated as safety issue: No ]
    No. of patients with adenoma detected
Estimated Enrollment: 380
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Narrow band imaging
Colonoscopy with new narrow band imaging
 Other: Narrow band imaging
Colonoscopy with new narrow band imaging

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
  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients scheduled to have colonoscopy for screening, surveillance or symptoms

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725321

Locations
China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01725321     History of Changes
Other Study ID Numbers: NBI_1
Study First Received: November 8, 2012
Last Updated: December 18, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Colonoscopy
colonic adenoma
serrated polyps

ClinicalTrials.gov processed this record on March 03, 2015