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Colorectal Polyp clinical trials

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NCT ID: NCT04824053 Recruiting - Colorectal Polyp Clinical Trials

Effects of UNICLA-A2 Dairy Products on Patients at High-risk of Colorectal Cancer Development

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

Dietary intervention with UNICLA-A2 milk products containing beta casein A2 protein, and higher levels of omega-3 fatty acids and selenium may contribute to maintain the intestinal integrity, reduce inflammatory processes, normalize the immune system, protect against oxidative damage and equilibrate the gut microbiota in high-risk colorectal cancer patients who have undergone polypectomy

NCT ID: NCT04407416 Recruiting - Colorectal Cancer Clinical Trials

VOCs vs FIT for Colorectal Cancer Screening

Start date: May 2, 2020
Phase: N/A
Study type: Interventional

Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled. Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC. Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction. Aim of the study To compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test.

NCT ID: NCT04308824 Recruiting - Colorectal Polyp Clinical Trials

Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

Start date: February 2, 2019
Phase: N/A
Study type: Interventional

Endoscopic resection of large non-pedunculated adenomas is most often performed using the 'lift-and-cut' endoscopic mucosal resection (EMR) technique. This endoscopic technique has a relatively low technical complexity and short-duration and is commonly considered a safe and reliable surgical option, nevertheless several adverse events can occur during or after this procedure. One of the most frequent late complication is the post-procedural bleeding occurring up to 30 days post-polypectomy, which often requires emergency hospitalization and re-intervention. Endoscopic hemostasis of active post procedure bleeding can be achieved using prophylactic clips. Recently, the use on sprayable hemostatic agents have been introduced in the gastrointestinal endoscopical practice. Cyanoacrylate is a liquid tissue adhesive that has been proved to be of some utility in the endoscopic management of gastrointestinal variceal bleeding. In this study the investigators aim to compare the rate of postoperative bleeding between two groups of patients with large colorectal polyps. In the first group it will be performed a prophylactic clipping after the polypectomy and in the other group it will be used cyanoacrylate after clipping.

NCT ID: NCT04307901 Recruiting - Colorectal Cancer Clinical Trials

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

SOCRATEC
Start date: May 1, 2020
Phase:
Study type: Observational

Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete. Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.

NCT ID: NCT04196088 Recruiting - Colorectal Adenoma Clinical Trials

To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age

AIDA
Start date: June 11, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.

NCT ID: NCT04149184 Recruiting - Colorectal Cancer Clinical Trials

Computer-aided Detection Device in Standard Colonoscopy

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

The aim of this study is to evaluate the clinical benefit and safety of using an AI device in colonoscopy procedures with the indication of screening or surveillance.

NCT ID: NCT03859479 Recruiting - Colorectal Polyp Clinical Trials

Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

Start date: January 20, 2019
Phase: N/A
Study type: Interventional

A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.

NCT ID: NCT03750617 Recruiting - Colorectal Polyp Clinical Trials

Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.

NCT ID: NCT03612674 Recruiting - Colorectal Cancer Clinical Trials

Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial

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

In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots. ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge. Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.

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.