Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

NCT01725321 | Completed

• 1 other identifier: NBI_1
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Neoplasm

Keywords

Colonoscopy; colonic adenoma; serrated polyps

Outcome Measures

Primary Outcomes (1)

• Detection rate of proximal serrated polyp

  No. of patients with proximal serrated polyps

  During colonoscopy

Secondary Outcomes (1)

• Missed rate for proximal serrated polyps

  During colonoscopy

Other Outcomes (1)

• Adenoma detection rate

  during colonoscopy

Study Arms (1)

Narrow band imaging

Colonoscopy with new narrow band imaging

Other: Narrow band imaging

Interventions

Narrow band imaging OTHER

Colonoscopy with new narrow band imaging

Narrow band imaging

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled to have colonoscopy for screening, surveillance or symptoms

You may qualify if:

• All patients scheduled to have colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Wai Keung Leung, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

CN (1)