Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Colonic Neoplasm	Other: 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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	360 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
Study Start Date :	October 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	October 2013

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Detection rate of proximal serrated polyp [ Time Frame: During colonoscopy ]
   No. of patients with proximal serrated polyps

Secondary Outcome Measures :

1. Missed rate for proximal serrated polyps [ Time Frame: During colonoscopy ]
   Missing rate for proximal serrated polyps

Other Outcome Measures:

1. Adenoma detection rate [ Time Frame: during colonoscopy ]
   No. of patients with adenoma detected

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	November 12, 2012
Last Update Posted:	May 29, 2015
Last Verified:	May 2015

Keywords provided by LEUNG Wai Keung, The University of Hong Kong:

Colonoscopy; colonic adenoma; serrated polyps

Additional relevant MeSH terms:

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