Active clinical trials for "Adenoma"

Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation. The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day. The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.

Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials are lacking. The study objective is to examine whether fellow participation during screening, surveillance, or diagnostic colonoscopy influence overall, size-specific, or location-specific adenoma or polyp detection rate. It will be planned to enroll 812 patients (406 per arms) within 1 year. Adenoma detection rate will be the primary outcome.

Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone Design: Multicenter, Prospective, randomized controlled study Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study

Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.

Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas. Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect. The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy. If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.This system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier. Aim of the study is to compare the accuracy of white light and BLI systems in real-time histology prediction of colonic polyps. For this purpose all colonscopies will be performed in a standard fashion using white light. When a polyps <10mm in size will be identified, patients will be randomized in two groups. In the Group 1 (White Light Grroup), all polyps <10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface pattern. The level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded. Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using BLI or white light.

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.