Study of Narrow Band Imaging in the Characterization of Serrated Lesions

Colorectal Neoplasms Clinical Trial

— CROMOSER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406547
• Other study ID #: CROMOSER
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: May 3, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Serrated Polyps
• Sessile Serrated Adenoma

Intervention

Device:
• NBI
Withdrawal from cecum to sigmoid colon with Narrow Band Imaging (NBI, Evis Exera III, Olympus)
• WLE
Withdrawal from cecum to sigmoid colon with High Definition White Light Endoscopy (WLE)

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Boparai KS, van den Broek FJ, van Eeden S, Fockens P, Dekker E. Increased polyp detection using narrow band imaging compared with high resolution endoscopy in patients with hyperplastic polyposis syndrome. Endoscopy. 2011 Aug;43(8):676-82. doi: 10.1055/s- — View Citation

Brown SR, Baraza W. Chromoscopy versus conventional endoscopy for the detection of polyps in the colon and rectum. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD006439. doi: 10.1002/14651858.CD006439.pub3. Review. — View Citation

Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12. — View Citation

Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellisé M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastr — View Citation

Leggett B, Whitehall V. Role of the serrated pathway in colorectal cancer pathogenesis. Gastroenterology. 2010 Jun;138(6):2088-100. doi: 10.1053/j.gastro.2009.12.066. Review. — View Citation

Siegel R, Desantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):104-17. doi: 10.3322/caac.21220. Epub 2014 Mar 17. — View Citation

van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. Review. — View Citation

Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of polyps detected with both techniques (NBI versus WLE)	Efficacy of NBI in detecting serrated polyps compared with WLE	Less than 1 year after the basal colonoscopy	No
Secondary	Number of new patients who accomplish the SPS criteria		Less than 1 year after the basal colonoscopy	No
Secondary	Number of missed lesions on 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	No
Secondary	Number of accurate detection of adenomas with morphologic features with both groups (NBI and WLE) compared to histopathology	Accuracy in detecting adenomas endoscopically compared with histopathology (gold standard)	Less than 1 year after the basal colonoscopy	No