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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Narrow Band Imaging in the Characterization of Serrated Lesions

NCT02406547

Serrated Polyps Sessile Serrated Adenoma Colorectal Neoplasms

COMPLETED NA

White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

NCT05935124

Adenoma Colon

RECRUITING NA

Accuracy for Predicting Deep Submucosal Invasion

NCT03748667

Colorectal Cancer Colorectal Polyp

COMPLETED

NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

NCT00292175

Ulcerative Colitis

UNKNOWN NA

BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

NCT03696992

Colon Adenoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

WLE

Intervention Type DEVICE

Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)

NBI

Intervention Type DEVICE

Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).

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.

Group Type EXPERIMENTAL

WLE

Intervention Type DEVICE

Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)

NBI

Intervention Type DEVICE

Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WLE

Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)

Intervention Type DEVICE

NBI

Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

High Definition colonoscopy with White Light Endoscopy (WLE) Narrow Band Imaging

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No