AzTrials
AzTrials

Serrated PolypsCROMOSERNCT02406547

Study of Narrow Band Imaging in the Characterization of Serrated Lesions

A study testing NBI and WLE in people with Serrated Polyps and Sessile Serrated Adenoma, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
NBI and WLE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSpain
Study dates
Mar 2015to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital del Mar

    Barcelona, Barcelona, 08003

Other trials in Spain

About this study

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

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).

Read the detailed 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.

Being tested
NBI, WLE
Keywords
Serrated lesion, sessile serrated adenoma, Narrow Band Imaging, Colonoscopy, colorectal neoplasms
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBIDevice

    Also called Narrow Band Imaging

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

  • WLEDevice

    Also called High Definition White Light Endoscopy

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

Study groups in NCT02406547
Study groupRoleWhat they receive
WLE-NBIExperimentalParticipants 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.
Receives: Device: NBI; Device: WLE
NBI-WLEExperimentalParticipants 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.
Receives: Device: NBI; Device: WLE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of polyps detected with both techniques (NBI versus WLE)

    Efficacy of NBI in detecting serrated polyps compared with WLE

    Measured: Less than 1 year after the basal colonoscopy

Secondary outcomes (3)

  1. Number of new patients who accomplish the SPS criteria

    Measured: Less than 1 year after the basal colonoscopy

  2. 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)

    Measured: Less than 1 year after the basal colonoscopy

  3. 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)

    Measured: Less than 1 year after the basal colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionOct 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406547
Sponsor's protocol ID
CROMOSER
Acronym
CROMOSER
Status last verified
May 2016
First submitted
30 Mar 2015
Last updated
4 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.2012.12.027. Epub 2013 Feb 26.

    PubMed 23485231

  • 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.

    PubMed 24639052

  • 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. doi: 10.1056/NEJM199312303292701.

    PubMed 8247072

  • 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. doi: 10.1111/j.1572-0241.2006.00390.x.

    PubMed 16454841

  • 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.

    PubMed 20927746

  • Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise 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 Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.

    PubMed 24639382

  • 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-0030-1256447. Epub 2011 Aug 2.

    PubMed 21811939

  • 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.

    PubMed 20420948

  • Riu Pons F, Andreu M, Naranjo D, Alvarez-Gonzalez MA, Seoane A, Dedeu JM, Barranco L, Bessa X. Narrow-band imaging and high-definition white-light endoscopy in patients with serrated lesions not fulfilling criteria for serrated polyposis syndrome: a randomized controlled trial with tandem colonoscopy. BMC Gastroenterol. 2020 Apr 16;20(1):111. doi: 10.1186/s12876-020-01257-4.

    PubMed 32299380

Questions about this trial

What is this clinical trial studying?

A study testing NBI and WLE in people with Serrated Polyps and Sessile Serrated Adenoma, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of polyps detected with both techniques (NBI versus WLE) (time frame: Less than 1 year after the basal colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406547, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in