Accuracy for Predicting Deep Submucosal Invasion

NCT ID: NCT03748667

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 426 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-10-30

Brief Summary

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.

Detailed Description

A video with the lesion assessment, without any data on the patient, will be recorded in a device connected to the processor provided by the Principal Investigator. The name of the file will be the record ID. All the lesions will be tested by the same endoscopist in vivo and an assistant will fulfill the data collection sheet during the colonoscopy.

First, the lesions will be cleaned and observed in a stable position. Size, location, morphology, demarcated areas, and gross morphological malignant features will be evaluated. Based on these WLE characteristics, a deep invasion prediction will be performed (control test). Second, the lesion will be assessed using NBI with near focus or magnification or BLI with magnification. A second cleaning with pronase (or N-acetylcysteine if pronase is not available) if the surface cannot be clearly observed because of the presence of mucus or if crystal violet is going to be used. Crystal violet 0.05% will be used in case of polyps type 2B in the JNET classification or lesions with a demarcated area. A non-traumatic catheter (or spray catheter) will be used to spray the crystal violet over the lesion. A final prediction of deep invasion will be performed for NBI or BLI ± CE (test evaluated).

The use of a cap to observe the bottom of the lesion, fix the lesion close to the endoscope or to observe the lesion underwater immersion is strongly recommended.

The resection technique will be decided upon according to the local experience. In case of endoscopy resection (cold snare, EMR, ESD, full thickness), lesions will be removed via the anus (not through the endoscopy channel) in order to preserve their integrity. Although EMR is performed, if possible, lesions will be referred to the pathologist well oriented and pinned out on a cork based, as is standard procedure in ESD.

In order to ensure that endoscopic assessment is performed before the histology evaluation, both diagnostic assessments (control test and test evaluated) will be recorded on the REDCap database on the day of the colonoscopy. REDCap records the time and date of all changes in the variables' results. The remaining variables (demographic data, etc.) will be recorded on the data collection sheet and copied later into REDCap.

Videos of the lesion assessments will be sent to the Principal Investigator. Centralized visualization will be conducted to detect protocol violations and to exclude lesions from the study.

A blinded histology assessment will be conducted by the local pathologist and if a carcinoma with submucosal invasion is diagnosed, histology slides will be referred for an additional blinded and centralized histology evaluation at the end of the study.

Pathologists participating in the histological phase will assess all the slides with submucosal invasion and will collect the histological factors associated with lymph node metastasis.

Finally, investigators participating in the translational phase will refer paraffin blocks of 10 lesions of each JNET category (2A, 2B and 3) for genetic tests (sequencing of a panel of 45 genes and analysis of alterations in the number of copies of the genome).

Conditions

Colorectal Cancer; Colorectal Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with colorectal polyps

Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm

White light endoscopy (WLE)

Intervention Type: DIAGNOSTIC_TEST

Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.

NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

White light endoscopy (WLE)

Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.

Intervention Type: DIAGNOSTIC_TEST

NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Non-pedunculated type 0 lesions in Paris classification (not obvious cancers)
• Lesions larger than 10 mm

Exclusion Criteria

• Lesions assessed as JNET 1 by the endoscopist or serrated by the pathologist
• Previous biopsy or resection attempt
• Previous CT, MR or USE
• Unavailable histology
• Inflammatory bowel disease
• Informed consent not obtained
• Protocol violation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Hospital Clínico Universitario Lozano Blesa

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

National Cancer Center, Japan

OTHER_GOV

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role: collaborator

Hospital Comarcal de Alcañiz

UNKNOWN

Sponsor Role: collaborator

Centro Medico Teknon

OTHER

Sponsor Role: collaborator

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Ignasi Puig

Gastroenterology consultant, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignasi Puig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Locations

San Francisco Veterans Affairs Medical Center. University of California

San Francisco, California, United States

University of North Carolina

Chapel Hill, North Carolina, United States

National Cancer Center

Tokyo, , Japan

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Hospital Universitari Germans Trias i Pujol (Can Ruti)

Badalona, Catalonia, Spain

Hospital Clínic de Barcelona

Barcelona, Catalonia, Spain

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

Barcelona, Catalonia, Spain

Althaia. Xarxa Assistencial Universitària de Manresa

Manresa, Catalonia, Spain

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Comarcal de Alcañiz

Alcañiz, Teruel, Spain

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, Spain

Centro Médico Teknon

Barcelona, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Countries

United States; Japan; Spain

References

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.

Reference Type: BACKGROUND

PMID: 27644737 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23910062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26927367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30296432 (View on PubMed)

Other Identifiers

CEIC 18/53

Identifier Type: -

Identifier Source: org_study_id