Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of the NICE Classification Using Pentax Chromoendoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155308
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

Brief Summary:
Colorectal cancer (CRC) is the most frequent gastrointestinal tumor and the second cause of cancer related death. Colonoscopy is currently the recommended method for detection of polyps and cancers in the colon. Removal of all adenomatous polyps during colonoscopy has become worldwide a standard procedure as it has been demonstrated to significantly reduce colorectal cancer incidence and mortality. It is routine practice to remove all the detected polyps for pathological evaluation, due to the low accuracy (59% to 84%) to differentiate non-neoplastic from neoplastic colorectal lesions with white-light endoscopy. The development of electronic or virtual chromoendoscopy (CE) has aimed to reliably predict histology of colorectal lesions based on endoscopic features. This technology differentiates between neoplastic and non-neoplastic lesions base on the analysis of the neo-angiogenesis and the mucosal pit pattern. Optical endoscopic diagnosis allows the real-time evaluation of polyp histology during colonoscopy and to determine the appropriate therapeutic strategy. This is important in clinical practice, since adenomas or superficial invasive submucosal carcinoma lesions can be curatively treated by endoscopic removal, unlike deeply invasive carcinomas, which requires surgery. The Narrow-band imaging (NBI) international colorectal endoscopic (NICE) classification is validated classification system proposed as a valid tool for not only differentiating hyperplastic from adenomatous polyps, but also predicting submucosal deep (SM-d) carcinomas. It was developed based on NBI technology, leaving uncertainty on its applicability to other systems. It was previously evaluated the application of the NICE classification to Fujinon spectral Imaging Color Enhancement (FICE) technology founding suboptimal results (accuracy 77%, sensitivity 77% and specificity 75%) and moderate inter-observer agreement (kappa: 0.51).

Condition or disease Intervention/treatment
Colorectal Polyp Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Validation of the NICE Classification Using Pentax Chromoendoscopy (I-scan and Optical Enhancement System
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Group/Cohort Intervention/treatment
Polyp group
Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is perform will be enrolled to be evaluated using Pentax chromoendoscopy (i-scan and Optical Enhancement)
Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)
All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.




Primary Outcome Measures :
  1. Diagnostic accuracy of Pentax chromoendoscopy (i-scan and Optical Enhancement system) for differentiating between the three types of NICE classification. [ Time Frame: 4 month ]
    colorectal polypoid lesions will be evaluated using Pentax chromoendoscopy (i-scan and OE system) in order to classified the lesions by NICE classification. The histopathology will be evaluated from all lesions as Gold Standard and finally accuracy, sensitivity, specificity, positive predictive value and negative predictive value will be calculated.


Secondary Outcome Measures :
  1. assessment of inter- and intra-observer agreement [ Time Frame: 4 month ]
    A data set containing 30 random-selected videos will be presented after 2 months to the three main investigators (C.R.M, M.V, M.S.A.) in order to assess intra and inter-observer reproducibility. The endoscopists will have classified again the polyps according to the three types on the NICE classification. To examine inter and intra observer agreement, kappa values will be calculated. Kappa coefficients below 0.4 indicate "poor agreement," values between 0.4 and 0.8 represent "moderate to good agreement," and values greater than 0.8 indicate "excellent agreement."

  2. Diagnostic accuracy of the individual criteria of NICE classification using i-scan and OE system. [ Time Frame: 4 month ]
    It will be calculated the accuracy, sensitivity, specificity, negative and positive predictive values with the 95% of Confidence Interval (95% CI), for each component of the classification and for the overall prediction by using the classification. Using multilevel logistic regression, the sensitivity and specificity of the different criteria, will be compared. Diagnostic values of the criteria used in combination (combination of "at least 1 criterion being positive" versus "all combined criteria being positive") will be assessed and compared. The criterion standard for validation of predictions will be the lesions histology. Presence of adenomatous feature at each criterion will be defined as a positive result.

  3. Diagnostic accuracy according to the level of confidence. [ Time Frame: 4 month ]
    A level of confidence (high or low) will be assign in each stage. A high confidence prediction will be considered when the endoscopist is 90% certain of the diagnosis and this condition will be consider when polyps have ≥1 features associated with one NICE type and no features associated to the others NICE type. If there are uncertainty regarding the features or if there are features from different NICE types the prediction will have low confidence.


Biospecimen Retention:   Samples Without DNA
colorectal polyps will be resected y biopsed


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is performed will be enrolled.
Criteria

Inclusion Criteria: Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is performed will be enrolled.

Exclusion Criteria: pregnancy, suspected colonic obstruction or history of previous obstruction, gastrointestinal bleeding, history colorectal surgery, inflammatory bowel disease, hereditary polyposis syndrome, diverticulitis, history of radiation therapy to abdomen or pelvis, history of severe cardiovascular, pulmonary, liver or renal disease, severe coagulation disorders or use of anticoagulants.

Patients with polyps but in whom histopathology has not been evaluated or with a poor bowel preparation (Boston Bowel Preparation Scale ≤6) will be excluded from the analysis but included in the intention to treat.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155308


Locations
Layout table for location information
Ecuador
Ecuadorian Institute of Digestive Diseases, Omnihospital
Guayaquil, Guayas, Ecuador, 090505
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
Layout table for investigator information
Principal Investigator: Carlos A Robles-Madranda, MD Ecuadorian Institute of Digestive Diseases
Publications of Results:

Other Publications:
US Cancer Statistics Working Group. United States Cancer Statistics: 1999 - 2005 Incidence and Mortality Web-Based Report. US Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute: Atlanta, 2009
Gono K, Yamazaki K, Doguchi N et al. Endoscopic observation of tissue by narrow band illumination. Opt. Rev. 2003; 10: 211-5.

Layout table for additonal information
Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT03155308    
Other Study ID Numbers: MAY 2-2017
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No