Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Colonic Neoplasm Clinical Trial

Official title:

Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725321
• Other study ID #: NBI_1
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: May 28, 2015
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasm
• Colonic Neoplasms

Intervention

Other:
• Narrow band imaging
Colonoscopy with new narrow band imaging

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adenoma detection rate	No. of patients with adenoma detected	during colonoscopy	No
Primary	Detection rate of proximal serrated polyp	No. of patients with proximal serrated polyps	During colonoscopy	No
Secondary	Missed rate for proximal serrated polyps	Missing rate for proximal serrated polyps	During colonoscopy	No