Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection (CROMOPIE)

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 Endoscopic Piecemeal Mucosal Resection

This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) for detection of residual neoplasia in subjects with piecemeal polypectomy scars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Resection of large sessile polyps in the colon (usually more than 2 cm) or those nonpolypoid neoplastic lesions (also called laterally spreading tumors or LST), confers technical difficulty and often are forced to remove into fragmented resection or endoscopic piecemeal mucosal resection. This has been associated with a recurrence of 25%. For this reason, clinical guidelines recommend endoscopic follow-up at 2 to 6 months after piecemeal resection of colorectal polyps to check for residual neoplasia.

Narrow-Band Imaging (NBI, Olympus) improves visibility and identification of the surface and vascular structures of colon polyps. In contrast to conventional chromoendoscopy, it is easily activated by pressing a button on the endoscope.

Virtual or conventional chromoendoscopy are applied during resection of polyps defining the border of the lesion. However, there are few studies using Narrow Band Imaging and do not allow to know whether the use of this technique could improve the detection of residual tumor after fragmented polypectomy and avoid complications, time and costs of biopsy and histological analysis.

In this context, 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 or virtual chromoendoscopy in patients with piecemeal polypectomy scar (strong recommendation, low quality evidence).

The investigators will perform a randomised, controlled trial of tandem colonoscopy using NBI and WLE. The main goal is to compare the rate of detected neoplasia between both techniques and evaluate the diagnostic accuracy of NBI and WLE to histology as the gold standard.

Study Type

Interventional

Enrollment (Actual)

120

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years old who underwent a colonoscopy for any reason in the last 12 month
  • Patients with a basal colonoscopy findings: ≥1 polyp removed in a piecemeal fashion regardless of the size

Exclusion Criteria:

  • Diagnosis of a CRC in the basal colonoscopy
  • 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, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly High Definition White Light Endoscopy (WLE) and secondly Narrow Band Imaging. All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.
Device: WLE
Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
Other Names:
  • High Definition colonoscopy with White Light Endoscopy (WLE)
Device: NBI
Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).
Other Names:
  • Narrow Band Imaging
Experimental: NBI-WLE
Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly Narrow Band Imaging and secondly High Definition White Light Endoscopy (WLE). All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.
Device: WLE
Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
Other Names:
  • High Definition colonoscopy with White Light Endoscopy (WLE)
Device: NBI
Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).
Other Names:
  • Narrow Band Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of residual neoplastic tissue detected with both techniques (NBI versus WLE)
Time Frame: less than 1 year after the basal colonoscopy
Efficacy of NBI in detecting residual neoplasia compared with WLE
less than 1 year after the basal colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of accurate detection of residual neoplastic tissue with morphologic features in both groups (NBI and WLE) compared with histopathology
Time Frame: less than 1 year after the basal colonoscopy
Accuracy in detecting neoplastic tissue endoscopically compared with histopathology (gold standard)
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 from the basal colonoscopy
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

May 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 19, 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

  • CROMOPIE

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.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on WLE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe