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Polyps clinical trials

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NCT ID: NCT04837690 Not yet recruiting - Colon Polyp Clinical Trials

UEMR for Medium-sized Pedunculated Colon Polyps

Start date: May 1, 2021
Phase:
Study type: Observational

Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.

NCT ID: NCT04816292 Not yet recruiting - Adenomatous Polyps Clinical Trials

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm)

COLDSNAP-2
Start date: April 2021
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 5-15 mm with CSP and HSP.

NCT ID: NCT04576780 Not yet recruiting - Polyp Colorectal Clinical Trials

An Integrated Management Pathway for Complex Colorectal Polyps

Start date: January 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes

NCT ID: NCT04515082 Not yet recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

Start date: August 2020
Phase:
Study type: Observational

The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

NCT ID: NCT04464837 Not yet recruiting - Colorectal Adenoma Clinical Trials

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

COLDSNAP-1
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.

NCT ID: NCT03843567 Not yet recruiting - Colorectal Polyp Clinical Trials

Prediction of Diminutive/Small Polyp Histology: Didactic vs. Computer-based Training

Start date: March 2019
Phase: N/A
Study type: Interventional

Bowel cancer is one of the most common cancers and the best method of diagnosing it is through endoscopic examination of the bowel (colonoscopy). Pre-cursors of bowel cancer are called polyps which can be detected and removed at the time of the colonoscopy. This reduces the chance of developing bowel cancer. There are different types of polyp ranging from completely harmless to those that may develop into cancer over time. Advances in technology mean more polyps are being detected and it is possible to predict the type of polyp. Therefore there is a new strategy in endoscopy whereby when a small polyp is detected, a prediction of polyp type is made, the polyp removed and then discarded rather than sending to the laboratory, thereby reducing costs to health services. In the hands of experts, accuracies in predicting polyp type is similar to when the polyp is removed and sent to the lab for analysis. Whilst experts can do this, non-experts cannot reach these standards and there is a need for effective training. The aim of the study is to compare the effectiveness of two training methods: Didactic face-to-face training and computer-based self-learning on the ability of trainees at predicting polyp type.

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: 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: 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: 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