Study of Narrow Band Imaging in the Characterization of Serrated Lesions (CROMOSER)

May 3, 2016 updated by: Fausto Riu, Parc de Salut Mar

Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Serrated Lesions

This study is designed to evaluate the utility of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) in subjects with serrated lesions who do not fulfill the diagnostic criteria of Serrated Polyposis Syndrome (SPS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is the second leading cause of cancer death in western countries. Conventional polyps were considered the precursor lesions of all cases of sporadic colon cancer. Recently, serrated lesions and especially the Sessile Serrated Adenoma (SSA), are responsible of interval CRC between 20% to 35% of all CRC cases. These polyps are difficult to identify at endoscopy because they are located in the right colon, they are sessile or flat morphology and are pale color with mucus capping.

According to the WHO, SPS is defined with one of the following criteria: (1) at least 5 serrated polyps proximal to the sigmoid colon, 2 of which are greater than 10 mm in diameter; (2) any number of serrated polyps occurring proximal to the sigmoid colon in an individual who has a first-degree relative with serrated polyposis; or (3) more than 20 serrated polyps of any size distributed throughout the colon. Therefore, patients with SPS are considered to be at increased risk of CRC. Considering the substantial risk of polyp recurrence, it is mandatory to follow up an annual surveillance.

Narrow-Band Imaging (NBI, Olympus) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. Blood vessels will appear dark, allowing an improved visibility and identification of the surface and vascular structures. In contrast to conventional chromoendoscopy, it is easily activated by pressing a button on the endoscope. A pilot study in patients with SPS showed significantly lower polyp miss rate with NBI compared with WLE. Furthermore, the European Society of Gastrointestinal Endoscopy (ESGE) has recently published the first Guideline of Advanced Endoscopic Imaging for the detection and differentiation of colorectal neoplasia and recommends conventional chromoendoscopy or NBI in patients with SPS (strong recommendation, low quality evidence).

The hypothesis is that NBI could improve the detection rate of serrated polyps compared with WLE in patients who do not accomplish the SPS criteria.

The investigators will perform a randomised, cross-over trial of tandem colonoscopy using NBI and WLE. The main goal is to compare the rate of detected polyps between both techniques and, if it is necessary, reassessing the diagnosis for an appropriate surveillance interval.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 50 years old who accept CRC screening colonoscopy
  • Patients with a basal colonoscopy findings: ≥1 serrated polyps proximal to the sigmoid colon, which are greater than ≥10mm in diameter; or ≥3 serrated polyps proximal to the sigmoid colon

Exclusion Criteria:

  • Diagnosis of a CRC in the basal colonoscopy
  • Subjects with other types of histology polyps
  • Subjects who neglect to follow-up
  • Subjects who do not accept informed consent
  • Subjects with high risk of perforation or complications due to sedation, including patients with comorbidities (ASA IV-V)
  • Inadequate bowel preparation for colonoscopy (defined by Boston Bowel Preparation Score (BBPS): ≤ 5 total points; or 0-1 points in any of the 3 segments of the colon)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WLE-NBI
Participants will be evaluated by same endoscopist, back-to-back tandem colonoscopy. It consists of two withdrawal from the cecum to sigmoid colon using firstly High Definition White Light Endoscopy (WLE) and secondly Narrow Band Imaging (NBI). All detected polyps will be classified macroscopically and resected in each withdrawal.
Device: NBI
Withdrawal from cecum to sigmoid colon with Narrow Band Imaging (NBI, Evis Exera III, Olympus)
Other Names:
  • Narrow Band Imaging
Device: WLE
Withdrawal from cecum to sigmoid colon with High Definition White Light Endoscopy (WLE)
Other Names:
  • High Definition White Light Endoscopy
Experimental: NBI-WLE
Participants will be evaluated by same endoscopist, back-to-back tandem colonoscopy. It consists of two withdrawal from the cecum to sigmoid colon using firstly Narrow Band Imaging (NBI) and secondly High Definition White Light Endoscopy (WLE). All detected polyps will be classified macroscopically and resected in each withdrawal.
Device: NBI
Withdrawal from cecum to sigmoid colon with Narrow Band Imaging (NBI, Evis Exera III, Olympus)
Other Names:
  • Narrow Band Imaging
Device: WLE
Withdrawal from cecum to sigmoid colon with High Definition White Light Endoscopy (WLE)
Other Names:
  • High Definition White Light Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of polyps detected with both techniques (NBI versus WLE)
Time Frame: Less than 1 year after the basal colonoscopy
Efficacy of NBI in detecting serrated polyps compared with WLE
Less than 1 year after the basal colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of new patients who accomplish the SPS criteria
Time Frame: Less than 1 year after the basal colonoscopy
Less than 1 year after the basal colonoscopy
Number of missed lesions on basal colonoscopy
Time Frame: Less than 1 year after the basal colonoscopy
Compare the number of missed lesions on the index examination based on the colonoscopy findings (NBI and WLE)
Less than 1 year after the basal colonoscopy
Number of accurate detection of adenomas with morphologic features with both groups (NBI and WLE) compared to histopathology
Time Frame: Less than 1 year after the basal colonoscopy
Accuracy in detecting adenomas endoscopically compared with histopathology (gold standard)
Less than 1 year after the basal colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Fausto Riu, MD, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROMOSER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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