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Adenomatous Polyps clinical trials

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NCT ID: NCT02476682 Completed - Adenomatous Polyps Clinical Trials

Non-invasive Risk Stratification of CR AMN/SSP

FIT
Start date: January 11, 2016
Phase:
Study type: Observational

The purpose of this study is to determine the clinical utility of stool and blood methylation tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).

NCT ID: NCT02374515 Completed - Adenomatous Polyps Clinical Trials

Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

Start date: February 2015
Phase: N/A
Study type: Interventional

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy. Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

NCT ID: NCT02289053 Completed - Colorectal Cancer Clinical Trials

Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

Start date: April 1, 2006
Phase: N/A
Study type: Observational

Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.

NCT ID: NCT02117232 Completed - Clinical trials for Colonic Adenomatous Polyps

Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

Start date: March 2014
Phase: N/A
Study type: Interventional

Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum. Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.

NCT ID: NCT02051465 Completed - Clinical trials for Colonic Adenomatous Polyps

Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM

Start date: May 2013
Phase: N/A
Study type: Interventional

Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer. Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.

NCT ID: NCT01935180 Completed - Adenomatous Polyps Clinical Trials

Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial)

CAP
Start date: December 2010
Phase: N/A
Study type: Interventional

Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a colonoscopy. It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds, and some early studies have suggested an increased polyp and adenoma detection using this technology. However, the studies have in part substantial methodological limitations (e.g. missing polyp histology, single endoscopist study, polyps not removed at the time of detection). Therefore, at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection. The investigators propose a two-center multiple endoscopists randomized controlled trial. Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean number of adenoma per patient). The investigators will assess and adjust for possible variables that can affect adenoma detection, including withdrawal time and quality of colon preparation. As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists (a minimum of six) new to this method. In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology.

NCT ID: NCT01675752 Completed - Adenomatous Polyp Clinical Trials

Small Hyperplastic and Adenomatous Reliability Protocol

SHARP
Start date: May 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01661764 Completed - Clinical trials for Colorectal Adenomatous Polyps

Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention

Start date: February 4, 2013
Phase: Phase 2
Study type: Interventional

Colorectal cancer is the second leading cause of cancer-related death within the United States. Animal models and observational studies have suggested that marine-derived n-3 polyunsaturated fatty acids [PUFA] such as eicosapentanoic acid [EPA] and docosahexanoic acid [DHA] may reduce the risk of colorectal cancer. In addition, it may be the relative proportion of n-3 to n-6 PUFAs that best determines the chemopreventive effects of fish oils. This ratio is important because the n-6 PUFA, arachidonic acid (ARA), is converted via the cyclo-oxygenase (COX) pathway to prostaglandin E2 (PGE2), an inflammatory eicosanoid overproduced in colorectal neoplasms while EPA is converted to the anti-inflammatory prostaglandin E3 (PGE3). While the ratio of n-6 to n-3 PUFAs can be altered through dietary changes, genetic factors may also influence this ratio. Recent genetic studies have demonstrated that much of the tissue levels of ARA is determined by differences in a gene called fatty acid desaturase 1 (FADS1). FADS1 is the rate-limiting enzyme in the conversion of linoleic acid, the most commonly consumed PUFA in the Western diet, to ARA, and one particular genetic variant caller rs174537 is associated with lower fatty acid desaturase activity and subsequently lower tissue levels of ARA. The study hypothesis is that individuals with genetically determined lower activity of FADS1 will derive greater benefit from fish oil supplementation than individuals with higher FADS1 activity because of lower tissue levels of ARA and subsequently a more favorable n-6 to n-3 PUFA ratio. To test this hypothesis the investigators will recruit 150 participants with recently identified adenomatous polyps and conduct a 6-month double blind 3 X 2 factorial randomized controlled trial. The first factor will be FADS1 genotype (GG, GT, and TT) and the second factor will be fish oil supplementation (fish oil versus placebo). The primary outcome will be the change in rectal epithelial cell growth and cell death. Secondary outcomes will include rectal epithelial cell expression of genes important in PGE2 production, rectal cell production of PGE2 and PGE3, rectal mucosal tissue levels of fatty acids, and changes in biomarkers of inflammation (C-reactive protein), adipokines (leptin, adiponectin), and markers of insulin sensitivity. The specific aims include: 1) to determine the efficacy of fish oil supplements on rectal epithelial cell proliferation indexes and markers of rectal crypt apoptosis, and 2) to determine the effect of genetically-determined fatty acid desaturase 1 activity on fish oil supplementation for colorectal cancer chemoprevention. The investigators long-term objectives are to determine genetic factors that might influence the efficacy of fish oil supplementation in order to conduct a more definitive adenoma recurrence trial using marine-derived n-3 PUFAs. The investigators anticipate that fish oil will have anti-neoplastic effect and individuals with low FADS1 activity will have a greater response compared to individuals with high FADS1 activity

NCT ID: NCT01656746 Completed - Crohn Disease Clinical Trials

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Start date: May 2010
Phase: N/A
Study type: Interventional

This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases

NCT ID: NCT01638091 Completed - Colonic Polyps Clinical Trials

Practice-Based Learning to Predict Polyp Histology at Colonoscopy

Start date: March 2011
Phase: N/A
Study type: Interventional

Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New technologies such as narrowband imaging (NBI) offer the possibility of in differentiation between precancerous and unimportant small polyps. Use of these technologies could decrease the costs and potentially the risks of screening and surveillance colonoscopy. Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating polyp types using NBI. The investigators hypothesize that community-based endoscopists can learn to identify polyp type at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that their experience can serve as guidelines for wider dissemination. The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at the use of NBI in the colon. This study will not affect the care of patients in any way. The research subjects will be the endoscopists, who will perform colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting to predict polyp type before resection.