Dataset Information

Endocuff-vision assisted chromoendoscopy for surveillance for cancer and dysplasia in inflammatory bowel disease

ABSTRACT: Interventions: This is a back-to-back crossover tandem colonoscopy study comparing the Endocuff device and standard care (high definition white light endoscopy with chromoendoscopy) compared with standard care alone for dysplasia surveillance in patients with inflammatory bowel disease. The Endocuff device is a small cap that attaches to the end of a standard colonoscope. Small, soft, finger-like projections extend from this cap on withdrawal of the colonoscope with the aim of flattening mucosal folds, anchoring the colonoscope and thus improving rate of dysplasia detection. The colonoscopies will be performed by endoscopists with training and experience in performing dye-spray chromoendoscopy, interventional endoscopy and who have had previous experience using the Endocuff device. All patients will receive two passes with the colonoscopy (one standard, and one with Endocuff) during the same anaesthetic, on the same day. Approximate length of each procedure will be about 15-20 minutes with a few minutes between crossover. This will occur at an endoscopy suite within Eastern Health. Follow-up will be via phone call at days 1, 7 and 21 post-procedure. Primary outcome(s): Dysplastic lesion miss rate: as defined as the number of lesions detected on the second colonoscopy which was missed during the first colonoscopy (regardless of Endocuff use or standard colonoscopy)[During colonoscopy];Dysplasia detection rate: as defined as the number of participants with one or more dysplastic lesions (adenomas with low-grade dyspalasia, adenomas with high-grade dysplasia, carcinoma insitu, invasive carcinoma)[During colonoscopy and confirmation with histology after colonoscopy] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy

DISEASE(S): Colorectal Cancer,Oral And Gastrointestinal-inflammatory Bowel Disease,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Inflammatory Bowel Disease

PROVIDER: 2466130 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Inflammatory bowel diseases (IBD) are chronic inflammatory disorders that can be categorized as ulcerative colitis (UC), Crohn’s disease (CD) and indeterminate colitis (IC). Deep remission has been shown to improve disease outcome. There may be a lack of concordance between endoscopic and histologic remission. IBD patients with long standing colitis are at risk of developing dysplasia and colorectal cancer (CRC). However, it can be challenging to diagnose dysplasia in IBD patients during colonoscopy, as dysplasia frequently manifests as non-pedunculated lesions that present with only subtle visible changes or are even invisible due to the surrounding inflammation, scarring, pseudopolyps, or hyperplasia. Although white light endoscopy and chromoendoscopy are the current standard modality of imaging, there is still a gap to be bridged, in terms of improving endoscopic diagnosis of dysplasia and improving concordance of endoscopic and histologic remission. Raman spectroscopy is an inelastic light scattering technique provide specific fingerprints of molecular compositions and structures of biological tissues. It may be able to provide additional diagnostic information over standard endoscopy. A second-generation Raman endoscope system for improving in vivo tissue characterization and diagnosis during colonoscopy has been developed (SPECTRA IMDx system). Preliminary data suggested its utility in the diagnosis of colorectal neoplasia during colonoscopy. There is currently a lack of data concerning the application of this novel technology in the context of IBD. Specifically, whether the spectral signals generated can be used to better classify disease remission, and thus achieve higher concordance with histology when compared to standard endoscopy. It is also unclear whether this technology can be used to differentiate dysplastic mucosa from non-dysplastic mucosal in IBD patients. Hypotheses 1. Raman spectroscopy based artificial intelligence system has the potential to be used to differentiate disease remission from active mucosal inflammation and hence improve concordance between endoscopic and histologic remission, with the potential to decrease the need for random biopsies real-time during colonoscopy. 2. Raman spectroscopy based artificial intelligence system has the potential to differentiate dysplastic mucosa in IBD patients (low grade and high grade dysplasia; colorectal cancer) from non-dysplastic mucosa. real-time during colonoscopy.

Project description:Colorectal cancer is the 2nd most common cause of death by cancer. Screening is therefore essential, with a positive impact for prevention, and in the visualization and removal of colonic adenomas, pre-cancerous lesions of colorectal cancer. The colonic adenoma detection rate (CADR), the gold standard for colonoscopy screening and screening studies, is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center. It varies between 25 and 45% depending on the center. There is a large inter-operator CADR variability, which has been linked to an increased incidence and excess mortality in colorectal cancers. To improve this detection rate, several innovative techniques have been developed: The endoscopic cap helps improve this detection rate: it is a 2cm tip with double row of plastic wings, fixed to the distal end of the colonoscope, which acts by unfolding the colonic haustrations allowing a better visualization of adenomas, and more particularly those of sessile morphology and sigmoidal location. Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone, with an adenoma detection rate optimization of 14%. Since then other devices, such as the Endocuff, have emerged with comparable efficacy. The Medtronic© GI GENIUS system integrates artificial intelligence (AI) to assist in the detection of polyps. It automatically identifies these precancerous lesions in real time. The study investigators previously performed a retrospective pilot study (COLODETECT), comparing colonoscopy alone as a control group, against AI alone and against the combined cap + AI. This study showed encouraging results in terms of colonic adenoma detection rate (60% for the AI + cap group versus 37% for the AI alone group versus 33% for the colonoscopy alone group, p=0.037) However, it requires a higher level of evidence to be validated in practice. This prospective COLODETECT2 study estimated an a priori expected difference between A.I. - Cap and A.I. alone of about 15% CADR. The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone. However, some limitations remain: existence of false positives (mucosal folds, residues), some morphological types still difficult to recognize (scalloped adenomas), non visualized colonic lesions. This study therefore focuses on the possible complementarity of these 2 medical devices, in order to maximize the detection rate of colonic adenomas, and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions, and consequently increasing the impact of colorectal cancer screening. The study authors hypothesize that the combination of GI GENIUS AI coupled with the ENDOCUFF VISION endoscopy cap provides a better colonic adenoma detection rate (CAD) during colonoscopy than either GI GENIUS AI alone or the ENDOCUFF VISION cap alone.

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Endocuff-vision assisted chromoendoscopy for surveillance for cancer and dysplasia in inflammatory bowel disease

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