NCT03748667|Completed
Accuracy for Predicting Deep Submucosal Invasion
NBIBLI
Diagnostic Accuracy of Deep Submucosal Invasion: White Light Endoscopy vs Invasive Pattern Based on NBI/BLI ± Chromoendoscopy
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NBIBLI
Diagnostic Accuracy of Deep Submucosal Invasion: White Light Endoscopy vs Invasive Pattern Based on NBI/BLI ± Chromoendoscopy
Sponsor study identifier
observational
426
3 countries
14
Study Start
December 1, 2018
Actual (reported)Primary Completion
September 28, 2022
Actual (reported)Study Completion
October 30, 2022
Actual (reported)The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2018
Actual (reported)November 21, 2018
Actual (reported)December 1, 2018
Actual (reported)September 28, 2022
Actual (reported)October 30, 2022
Actual (reported)The presence or absence of deep invasion according to the control test (WLE)
Deep invasion will subjectively be diagnosed based on the presence of gross morphological malignant features, morphology and size. No single malignant feature, specific morphology or size is required. The importance given to each criterion and the final diagnosis of deep invasion is based on the personal experience of the endoscopist.
One day
The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE)
Deep invasion will be diagnosed in case of: * JNET type 3 or * JNET 2B + Kudo Vn pit pattern or * JNET 2B and Kudo Vi pit pattern fulfilling all the following criteria: severe Kudo Vi pit pattern + presence of a demarcated area + size (demarcated area) \>6 mm for PG or 3 mm for NPG.
One day
Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm
Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.
Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.
Consecutive patients \> 18 years old who undergo a colonoscopy for any reason
San Francisco Veterans Affairs Medical Center. University of California
San Francisco, California, 94121, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
National Cancer Center
Tokyo, 104-0045, Japan
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Catalonia, 08916, Spain
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036, Spain
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Backes Y, Moss A, Reitsma JB, Siersema PD, Moons LM. Narrow Band Imaging, Magnifying Chromoendoscopy, and Gross Morphological Features for the Optical Diagnosis of T1 Colorectal Cancer and Deep Submucosal Invasion: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Jan;112(1):54-64. doi: 10.1038/ajg.2016.403. Epub 2016 Sep 20.
Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.
Paraffin blocks of colorectal polyps
Ignasi Puig, MD, PhD
Althaia Xarxa Assistencial Universitària de Manresa
426 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2018
First Posted
November 21, 2018
Study Start
December 1, 2018
Actual (reported)Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
The presence or absence of deep invasion according to the gold standard (histology)
Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.
One day
Presence of any genetic mutations
one day
Number of genome copies using SNP-arrays
one day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Barcelona, Catalonia, 08036, Spain
Althaia. Xarxa Assistencial Universitària de Manresa
Manresa, Catalonia, 08243, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Comarcal de Alcañiz
Alcañiz, Teruel, 44600, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, Valencia, 46009, Spain
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20.
Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
Primary Completion
September 28, 2022
Actual (reported)Study Completion
October 30, 2022
Actual (reported)Last Updated
September 21, 2023
Record last verified: 2023-09
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