Accuracy for Predicting Deep Submucosal Invasion
- Conditions
- Colorectal PolypColorectal Cancer
- Interventions
- Diagnostic Test: White light endoscopy (WLE)Diagnostic Test: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)
- Registration Number
- NCT03748667
- Lead Sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with colorectal polyps White light endoscopy (WLE) Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm Patients with colorectal polyps NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE) Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm
- Primary Outcome Measures
Name Time Method The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE) One day 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.The presence or absence of deep invasion according to the control test (WLE) One day 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.
The presence or absence of deep invasion according to the gold standard (histology) One day Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.
- Secondary Outcome Measures
Name Time Method Number of genome copies using SNP-arrays one day Number of copies using SNP-arrays.
Presence of any genetic mutations one day Sequencing of a panel of colorectal cancer genes: the 45 genes will be sequenced frequently mutated in colorectal cancer, through the protocols established in the center Executor: APC, TP53, FBXW7, SOX9, ATM, SMAD4, KRAS, PIK3CA, AMER1, FAT4, ARID1A, BRAF, NRAS, CTNNB1, TCF7L2, ERBB2, MET, EGFR, HRAS, SETD2, DLC1, CDKN2A, PTEN, ARID2, FAT1, POLE, POLD1, NOTCH1, BRCA2, LRP1B, KMT2C, KMT2D, DAPK1, CSMD1, MUC16, ADAMTS15, SYNE1, PCLO, ZFHX4, RYR3, RYR2, RELN, IRS2, GNAS, DMBT1.
Trial Locations
- Locations (14)
National Cancer Center
🇯🇵Tokyo, Japan
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
San Francisco Veterans Affairs Medical Center. University of California
🇺🇸San Francisco, California, United States
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario y Politécnico de La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Hospital Universitari Germans Trias i Pujol (Can Ruti)
🇪🇸Badalona, Cataluña, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
🇪🇸Barcelona, Cataluña, Spain
Centro Médico Teknon
🇪🇸Barcelona, Spain
Althaia. Xarxa Assistencial Universitària de Manresa
🇪🇸Manresa, Cataluña, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Comarcal de Alcañiz
🇪🇸Alcañiz, Teruel, Spain