Active clinical trials for "Polyps"

We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.

The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Presently, most endoscopists remove all polyps found and send them to the laboratory for testing. The number of colonoscopies is increasing, meaning that more polyps are detected and removed. This comes at a significant cost to the health service and increases the time taken to complete a colonoscopy.

Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the colon. At the present moment, all polyps should be resected endoscopically, although only 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 adenomas and hyperplastic polyps. Some studies have investigated the value of the socalled optical biopsy method. Optical biopsy means the visual assessment of the polyp and the determination of a diagnosis solely on behalf of optical criteria. This method is conducted in real time during colonoscopy. If it can be shown, that endoscopist using optical biopsy 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 hyperplastic polyps and small adenomas and discard them without further assessment by a pathologist. Gastroenterological societies demand for a 90 percent accordance between diagnoses set by endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy method. In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic polyps. NBI is a light filter tool which can be activated by pressing a button at the endoscope. NBI function 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 380 patients. Half of the patients will be examined without 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 NICE (NBI International Colorectal Endoscopic) 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 the new NBI tool accuracy (accordance between optical and histopathological diagnosis) can be increased from 78% to 90%.

1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess variability among endoscopists in NBI accuracy. We also aim to assess whether this technology impacts the appropriateness of surveillance intervals. Design: 1) Before starting the patient enrollment, the participating endoscopists will attend an internet-based training program on the in vivo differentiation between hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be required for each endoscopist to be included. 2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in order to rank between a high- and a low- level of diagnostic confidence, and thereafter will be sent for histological assessment. NBI- and histological accuracy in differentiating between hyperplastic and adenomatous lesions will be analyzed and compared, in order to assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI feasibility and accuracy in the study population, and to assess the variability among the endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical inference on how many patients would be scheduled for an inappropriate post-polypectomy follow up, when follow up schedule is based on NBI classification. Clinical results will be analyzed using various statistical measures of significance. Clinical Site Locations: 10 European centres with NBI-technology 1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.

Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic endpoints will form the basis for the assessment of treatment benefit of nasal polyp therapies. However, there is a lack of published qualitative data regarding nasal polyps to understand the symptoms or health-related quality of life (HRQoL) impacts. This cross-sectional qualitative study aims to address this unmet gap by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in duration) will investigate the subject experience of nasal polyps, and the relevance and understanding of existing patient-reported outcomes (PRO) instruments. The real-time data capture conducted over a 10 day period, will investigate the subject experience of the symptoms, HRQoL impacts and treatment of nasal polyps and any day-to-day variability that exists in these experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD interviews section of the study and of these, 10 subjects from US will also complete real-time data capture app task.

Recently, a CNN-based artificial intelligence (AI) system for polyp characterization has been developed by Fujifilm Co., Tokyo, Japan. It works in conjunction with BLI system. In the present study we prospectively evaluate whether the evaluation of the endoscopist combined with the CAD system output achieve > 90% accuracy in characterization (i.e. as adenomas or non-adenomas) of diminutive rectosigmoid polyps having histopathology as reference standard. Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected are included. During endoscopic procedures all polyps identified by the endoscopist are documented for size, location and morphology. All diminutive polyps are characterized by a three sequential steps process: I) endoscopist prediction: the endoscopist evaluates the polyp by using BLI through the BASIC classification; the confidence level (high vs. low) in histology prediction is recorded; II) AI prediction: the AI system is switched on and the output of the automatic evaluation is recorded; this outcome is rated as stable or unstable, depending of the consistency over time of the outcome; III) combined prediction: a final classification is provided by endoscopist in light of the results of the first and of the second step; the confidence level is recorded. All polyps are resected and retrieved in separate jars and sent for pathology assessment. Only polyps characterized with high confidence will be included in the per-polyp analysis; the high-confidence characterization rate will be also calculated; the rate of polyps characterized with a CAD stable outcome will be calculated. Operative characteristics (sensitivity, specificity, positive and negative predictive value and accuracy) in distinguishing adenomatous from non-adenomatous polyps, evaluated with high confidence, will be calculated for each diminutive polyp and for each diminutive rectosigmoid polyp, having histopathology report as reference standard. The post-polypectomy surveillance intervals will be calculated on the basis of polyp histology (reference standard) in all patients according to both USMSTF and ESGE guidelines.

During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.

Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study. By collecting data on hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.