Clinical trial NCT01725321: Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
Official title: Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasm
Keywords: Colonoscopy
colonic adenoma
serrated polyps
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to have colonoscopy for screening, surveillance or symptoms

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.

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 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

Primary outcomes:
measure: Detection rate of proximal serrated polyp
timeFrame: During colonoscopy
Secondary outcomes:
measure: Missed rate for proximal serrated polyps
timeFrame: During colonoscopy
Other outcomes:
measure: Adenoma detection rate
timeFrame: during colonoscopy
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai Keung Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: