Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
Ontology highlight
ABSTRACT:
DISEASE(S): Colonic Polyps,Colorectal Cancer,Colorectal Neoplasms,Polyps
PROVIDER: 2103409 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.
Primary Outcome:
To estimate the mean number of adenomas per colonoscopy for both high definition white light colonoscopy and I-scan enhanced colonoscopy
Secondary Outcomes:
1. To estimate the recruitment rate
2. Number of adenomas detected in the right colon during the second look
| 2126787 | ecrin-mdr-crc
Project description:Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.
| 2228885 | ecrin-mdr-crc
Project description:The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.
Primary Outcome:
Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.
Secondary Outcomes:
* Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
* Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
* Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
* Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
* Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
* Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
* Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study
* Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study
* Proportion of patients with Sessile Serrated Adenoma in each arm of the study
* Proportion of patients with invasive cancer in each arm of the study
* Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.
| 2157253 | ecrin-mdr-crc
Project description:The purpose of this study is to compare the adenoma detection rate of G-EYE high definition colonoscopy with that of standard high definition colonoscopy
| 2149692 | ecrin-mdr-crc
Project description:Application of multispecies probiotics reduces gastro-intestinal discomfort and increases microbial diversity after colonoscopy
| PRJEB56238 | ENA
Project description: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.
| 2305759 | ecrin-mdr-crc
Project description:Colorectal cancer (CRC) is a leading cause of cancer death and its’ incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.
Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.
| 2223112 | ecrin-mdr-crc
Project description:The purpose of this study is to compare the adenoma detection rate of G-EYE high definition colonoscopy with that of standard high definition colonoscopy.
| 2161063 | ecrin-mdr-crc
Project description:Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between these three polyp entities. Some studies have investigated the value of the optical characterization approach which is based on visual assessment of the polyp’ surface structures. Based upon optical polyp features users are encouraged to predict histopathological polyp diagnoses solely on behalf of optical or endoscopical criteria. This method is conducted in real time during colonoscopy. If it could be shown, that endoscopist using the optical characterization approach are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect small polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.
In this study we want to investigate whether the use of narrow-band imaging (NBI) would be capable to rise accuracy of optical polyp predictions compared to standard HD white light endoscopy. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns.
In a prospective randomised multicenter setting we plan to conduct colonoscopy in 370 patients. Half of the patients will be examined without the use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the WASP (Workgroup serrAted polypS and Polyposis) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using NBI accordance between optical and histopathological diagnosis can be increased from 80% to 90%.
| 2284776 | ecrin-mdr-crc
Project description:Interventions: Linked color imaging (LCI),Endocuff-assisted colonoscopy (EAC),Linked color imaging and Endocuff-assisted colonoscopy (LCI+EAC),Standard white light high-definition colonoscopy;Experimental Device,Experimental Device,Experimental Device,Placebo Comparator Device;Linked color imaging (LCI),Endocuff-assisted colonoscopy (EAC),Linked color imaging and Endocuff-assisted colonoscopy (LCI+EAC),Standard white light high-definition colonoscopy
Primary outcome(s): Adenoma detection rate in each group Crossectional study Adenoma from colonoscopies
Study Design: Randomized
| 2567682 | ecrin-mdr-crc