Clinical Trial: Study of Narrow Band Imaging in the Characterization of Serrated Lesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:

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
Sponsor: Parc de Salut Mar

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of new patients who accomplish the SPS criteria [ Time Frame: 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)
  • 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)


Original Secondary Outcome: Same as current

Information By: Parc de Salut Mar

Dates:
Date Received: March 30, 2015
Date Started: March 2015
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016