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Colonic Polyps clinical trials

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NCT ID: NCT06321614 Active, not recruiting - Clinical trials for Digestive System Disease

Deep Learning in Classifying Bowel Obstruction Radiographs

Start date: December 31, 2022
Phase:
Study type: Observational

Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples. Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation.

NCT ID: NCT04889352 Active, not recruiting - Colo-rectal Cancer Clinical Trials

Optimizing Timing of Follow-up Colonoscopy

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

NCT ID: NCT04739722 Active, not recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

CRC-PREVENT
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the Colosense test, which is a multi-target stool RNA test for colorectal screening.

NCT ID: NCT04451512 Active, not recruiting - Clinical trials for Colonic Polyps/Colonoscopy/Colorectal Neoplasms

Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.

Start date: January 1, 2020
Phase:
Study type: Observational

Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary,after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.

NCT ID: NCT03962868 Active, not recruiting - Colonic Polyp Clinical Trials

Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial

RESECT COLON
Start date: September 17, 2019
Phase: N/A
Study type: Interventional

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR. Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures. We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

NCT ID: NCT03942965 Active, not recruiting - Clinical trials for Adenomatous Polyp of Colon

Registry Evaluation of a Double Balloon Accessory Device

Start date: January 22, 2019
Phase:
Study type: Observational [Patient Registry]

This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.

NCT ID: NCT03865537 Active, not recruiting - Colonoscopy Clinical Trials

Cold Snare Endoscopic Mucosal Resection Trial

LPS-II
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

NCT ID: NCT03089268 Active, not recruiting - Colorectal Cancer Clinical Trials

Molecular and Histological Characteristics of Serrated Lesions of the Colon

SERRACOLON
Start date: June 1, 2017
Phase:
Study type: Observational [Patient Registry]

Different subtypes of serrated lesions have been recently described. Among them, both sessile serrated polyp/adenoma (SSP/A) and traditional serrated adenoma (TSA) could have malignant potential through the serrated pathway or CIMP. These lesions, as a potential source of interval cancer, should also be considered in colorectal cancer (CRC) population-based screening programs. It is believed that this new described pathway could be responsible for up to 30% of all CRC. Unlike the traditional adenoma, serrated lesions are difficult to diagnose because of their particular endoscopic appearance and their still unclear histological criteria. Furthermore, they have specific molecular changes and, through them, they could evolve into CRC faster than the adenoma. The real prevalence of the serrated lesions and their specific risk for developing new synchronous/metachronous lesions, or even malignancy, remains unknown. For all these reasons, we don't know if these patients could constitute a different CRC-risk group and if specific recommendations are needed during their follow-up. This is a prospective longitudinal study developed within the framework of the CRC-screening program in the Valencian Community (Spain). We expect to include a total of 700 individuals who will be followed during 10 years. In our study, we will collect epidemiologic variables related to the patient, variables related to all the polyps, and mutational (BRAF, KRAS, MSI), and CpG-island methylation status of serrated lesions. Strict endoscopic and histological criteria will be applied for the diagnosis of serrated lesions. All lesions detected at the index colonoscopy and during follow-up will be evaluated. The purpose of this study is to correlate epidemiologic data, histological characteristics and the molecular profile of the serrated lesions with findings during follow-up, in order to define stratified groups according to their risk of developing new lesions or CRC in the future.

NCT ID: NCT02532803 Active, not recruiting - Rectal Cancer Clinical Trials

Mri IN STaging REctal Polyp Planes

MINSTREL
Start date: August 13, 2015
Phase: N/A
Study type: Interventional

Early cancers of the rectum can be removed safely through the anus without subjecting patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence, hospital stay and avoiding a stoma that may be associated with pelvic surgery. Currently few of the patients eligible for TEMS are offered it for a variety of reasons that include uncertainties about the risk of leaving residual tumour and the increased risk of subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no role for imaging in assessing the malignant polyp. Conversely whilst retrospectively reviewing their MRI databank the investigators have found evidence that MRI can accurately judge the depth of these early tumours and thereby potentially identify patients for local excision. The investigators hope to prospectively test their hypothesis that an MRI scan can accurately gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring between 20mm and 50mm in size. The investigators will identify eligible patients awaiting surgery / polypectomy and if they consent to this pilot study participants will undergo an MRI to assess their tumour which assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established by reference to gold standard histopathology. Should MRI prove sensitive and specific then the investigators hope to change national guidelines to mandate MRI to standardise assessment and thereby increase the appropriate use of TEMS in the UK.

NCT ID: NCT02522702 Active, not recruiting - Colonic Polyps Clinical Trials

Computer Assisted Optical Assessment of Small Colorectal Polyps

Start date: August 2015
Phase: N/A
Study type: Observational

The aim of the study is to develop a computer program which is able to distinguish between adenomatous and non- adenomatous polyps on the basis of optical features of the polyps. Still images of polyps (< 10 mm of size) 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 adenomatous and non- adenomatous polyps on the basis of optical features derived from still images. The program will operated using the the random forest learning method. Afterwards, in the testing phase of the study, still images 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.