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Polyps clinical trials

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NCT ID: NCT03681093 Completed - Nasal Polyps Clinical Trials

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

THUNDER
Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

NCT ID: NCT03679429 Not yet recruiting - Clinical trials for Colorectal Carcinoma

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum

ADOPTION II
Start date: November 2018
Phase:
Study type: Observational

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%.

NCT ID: NCT03647176 Completed - Adenomatous Polyps Clinical Trials

A Comparison of the Resection Rate of Cold Snare Polypectomy for Large (10-15 mm) and Small (5-9 mm) Colorectal Polyps

CSP
Start date: September 3, 2018
Phase: N/A
Study type: Interventional

Colorectal cancer remains the third most common cause of death from cancer worldwide. Colonoscopy allows removal of adenomatous polyps is the best colorectal cancer screening, according to the adenoma-carcinoma sequence. Recent studies have reported approximately 30% of interval cancer may be incomplete polyp resection. Complete polyp resection may be particularly important when implementing new methods for surveillance colonoscopies. Cold snare polypectomy (CSP) is considered to be a safer procedure for removing subcentimeter lesions than conventional hot snare polypectomy (HSP). CSP removal of polyps sized ≤5 mm have recommended by the European Society of Gastrointestinal Endoscopy guideline as the preferred technique. Previous report said that the complete resection rate of CSP for adenomatous polyps 4-9 mm in size was comparable to that of HSP, and in the foreseeable future CSP can be one of the standard techniques for 4-9 mm colorectal polyps. However, data on complete resection of colorectal polyps 1.0-1.5 mm in size is sparse. Investigators are interested in comparison of the resection rate of cold snare polypectomy for large (10-15 mm) and small (5-9 mm) colorectal polyps using CSP.

NCT ID: NCT03627286 Recruiting - Nasal Polyps Clinical Trials

Effect of Benralizumab in Patients With Severe Nasal Polyps

OSTRO
Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized placebo controlled trial to evaluate the effect of benralizumab on people with severe nasal polyps.

NCT ID: NCT03623906 Not yet recruiting - Serrated Polyp Clinical Trials

Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. These morphological features may account for their diagnostic difficulty during colonoscopy. Missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. There is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. The investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.

NCT ID: NCT03620695 Recruiting - Colorectal Polyps Clinical Trials

Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

Start date: June 1, 2018
Phase:
Study type: Observational

Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.

NCT ID: NCT03601065 Not yet recruiting - Colonic Polyps Clinical Trials

Computer Assisted Detection & Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft

CASSANDRA II
Start date: August 2018
Phase:
Study type: Observational

The aim of the study is to develop a computer program which is able to automatically detect colorectal polyps in endoscopic video sequences. Furthermore, the program shall be able to automatically distinguish between adenomas, serrated adenomas and hyperplastic polyps on the basis of optical features of the polyps. Video sequences of polyps will be collected during routine colonoscopy procedures. All polyps will be resected endoscopically so that histopathological diagnoses (gold standard) can be notified. In the validation phase of the study a computer program will be established which aims to distinguish between adenomas, serrated adenomas and hyperplastic polyps on the basis of optical features derived from the videos. A deep learning approach will be used for programming. Afterwards, in the testing phase of the study, videos of 100 polyps (not used in the validation phase) will be presented to the computer program. The establishment of a well- functioning computer program is the primary aim of the study.

NCT ID: NCT03588416 Recruiting - Colorectal Cancer Clinical Trials

Multicentric Study About Pathological Risk Factors for Lymph Node Metastasis in Malignant Colorectal Polyps

POST-1
Start date: March 1, 2018
Phase:
Study type: Observational

Colorectal cancer screening showed an increased incidence of malignant colorectal polyps pT1 after endoscopic excision. Their management is not yet standardized, for the presence of histological features increasing early lymph node involvement. The literature has proposed several histopathological criteria, for which the risk of lymph node metastasis can vary (6-20%), but final data are not yet available. Aim 1.To collect data about patients undergoing an endoscopic polypectomy with histologic finding of pT1, retrospectively and prospectively, dividing both databases into two groups, endoscopic group (EG) and surgical group (SG) Aim 2. To analyze retrospectively which pathological criteria can increase the risk of lymph node metastasis and to elaborate a prognostic score for lymph node metastatic risk Aim 3. To verify prospectively the prognostic score capacity on predicting lymph node metastasis Aim 4. To calculate the disease free survival, overall survival, local recurrence rate and distal recurrence rate and verify if there is a difference between EG and SG According to literature, the most important histopathological criteria to establish the high risk of lymph node metastasis are: 1. Lateral margin of healthy tissue (high risk: <1mm and piecemeal polypectomy) 2. Depth of submucosa invasion (high risk: >1000 μM or sm2-sm3 for sessile polyps; Haggitt level 4 for pedunculated polyps) 3. Vascular invasion (high risk: presence) 4. Lymphatic invasion (high risk: presence) 5. Tumor budding (high risk: presence) 6. Tumor differentiation (high risk: grade G3-G4 or mucinous) A database will be used by all participating centres for collecting clinical and pathological data. All the analyses will be centralized by the PI. Uni-multivariate analyses will be conducted at the end of data collection for retrospective arm and at 2 years of follow-up for prospective arm. Impact: This study aimed to investigate pathological risk factors for lymph node metastasis in pT1 colorectal polyps after endoscopic polypectomy; their accurate identification could lead to improve their management, avoiding useless complementary surgery. Results could change clinical practice and reduce health-related costs.

NCT ID: NCT03569124 Not yet recruiting - Clinical trials for Identification of Colorectal Polyps

Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

Start date: October 1, 2024
Phase:
Study type: Observational

Interpretation of endoscopic characteristics of colorectal polyps with Blue Light Imaging A study of BLI images and videos of colorectal polyps will be presented initially as a training set followed by with explanation and teaching in a didactic session to two separate groups. A post-test will be conducted to look at the quality of the learning experience. To evaluate the teaching tool regarding the criteria for BLI images of colorectal polyps by the following measures - Inter-observer agreement between same and different groups - Accuracy in describing the morphology of colorectal polyps • This new teaching tool will improve - Inter-observer agreement by at least 5%- 10% (depending on the group) - Accuracy by at least 5%- 10% (depending on the group)• To determine the improvement of inter-observer agreement in identifying/ describing colorectal polyps after the didactic session in both the groups - Overall Accuracy, Sensitivity, Specificity, Positive predictive value and negative predictive value pre-and post-test in both the groups

NCT ID: NCT03567746 Recruiting - Colonic Polyp Clinical Trials

Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp

Start date: June 4, 2018
Phase: N/A
Study type: Interventional

To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).