Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Cicatrix

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

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.

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

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

Fausto Riu, MD

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.

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

Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Endoscopic Piecemeal Mucosal Resection

Efficacy of NBI in detecting residual neoplasia compared with WLE

Accuracy in detecting neoplastic tissue endoscopically compared with histopathology (gold standard)

Compare the number of missed lesions from the basal colonoscopy

Parc de Salut Mar

MD, PhD

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

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.

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.

Withdrawal from cecum to sigmoid colon with Narrow Band Imaging (NBI, Evis Exera III, Olympus)

Withdrawal from cecum to sigmoid colon with High Definition White Light Endoscopy (WLE)

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).

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 of Narrow Band Imaging in the Characterization of Serrated Lesions

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

Efficacy of NBI in detecting serrated polyps compared with WLE

Compare the number of missed lesions on the index examination based on the colonoscopy findings (NBI and WLE)

Accuracy in detecting adenomas endoscopically compared with histopathology (gold standard)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection	NCT02448693	Colorectal Neop...	WLE NBI	18 Years -	Parc de Salut Mar
Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection	NCT02448693	Colorectal Neop...	WLE NBI	18 Years -	Parc de Salut Mar
Study of Narrow Band Imaging in the Characterization of Serrated Lesions	NCT02406547	Serrated Polyps Sessile Serrate... Colorectal Neop...	NBI WLE	50 Years -	Parc de Salut Mar

Spots Global Cancer Trial Database for wle

Every month we try and update this database with for wle cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for wle

Every month we try and update this database with for wle cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for wle cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.