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Colonic Polyps clinical trials

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NCT ID: NCT03476434 Completed - Colonic Neoplasms Clinical Trials

Chromoendoscopy for Serrated Polyposis Syndrome

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

Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SLs) throughout the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the World Health Organization (WHO) defined this syndrome by any one of the following conditions: criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being >10mm in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC) at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of lesions are missed during conventional colonoscopy. This finding is even more evident when focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances the detection of subtle and flat polyps in the colon. Until the date no studies have assessed the use of dye-based chromoendoscopy in SPS patients. The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to estimate the SLs and adenoma miss rates in these patients. Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list of random numbers distributed by the coordinator center. After randomization, patients were submitted to tandem colonoscopies by the same endoscopist: - In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE. - In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air. After allowing a few seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine were suctioned and the mucosa was then scrutinised. Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for polypectomy and biopsies. Lesions detected during each inspection were described and then removed. Size (measured in comparison with an open biopsy forceps), morphology (using the Paris classification), location and polypectomy technique were recorded before removal. Histology was used as gold standard.

NCT ID: NCT03467451 Completed - Polyps of Colon Clinical Trials

Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage

Start date: July 1, 2015
Phase:
Study type: Observational

This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams

NCT ID: NCT03421600 Completed - Colonoscopy Clinical Trials

Blue Laser Imaging and White Light Imaging Colonic Polyps

Start date: July 12, 2017
Phase: N/A
Study type: Interventional

The adenoma detection rate by colonoscopy for asymptomatic individuals aged 50 years and older is estimated to be at least 25%. It is known that during colonoscopy, lesions may be missed. Image enhanced endoscopy techniques have been evaluated for the detection and differentiation of colonic polyps. Narrow band imaging (NBI), is one such technique. The common classification systems used predict histology is the NICE and the Sano and JNET classification. The NICE classification can be used without optical magnification; it evaluates the color of the lesion, regularity of the overlying vessels and regularity of the surface pattern. The Sano and JNET classification requires optical magnification in order to assess the capillary patterns such as whether there is dilation, irregularity or loss of irregular capillaries over the lesion. In the context of adenoma detection, the results are more contentious. A meta-analysis of randomized studies examining the utility of the first generation NBI system when compared to high definition WLI showed no difference in detection rates. A criticism of the NBI system had been the dark endoscopic view; this is a result of the optical filter, and can limit the far view. A second generation NBI system has since been developed. It is characterized by much brighter illumination despite the optical filter, and thus the far view is improved. A recent randomized controlled study compared the second-generation NBI system with high definition WLI. NBI was shown to improve polyp and adenoma detection rates compared to WLI. Blue laser imaging (BLI) is another form of narrow bandwidth imaging developed by Fujifilm Corporation (Tokyo, Japan). Instead of using an optical filter for white light to produce narrow bandwidths, the BLI system has a unique feature of illumination using two lasers and a white light phosphor to accomplish the visual enhancement of surface vessels and structures. This study aims to determine whether BLI can increase the detection rate of colonic polyps and adenomas when compared to white light endoscopy, with the null hypothesis being no difference in detection rates. This study will also examine the use of NICE and Sano/ JNET classification systems to predict histology with the BLI system.

NCT ID: NCT03390907 Completed - Colon Cancer Clinical Trials

Hybrid APC Assisted EMR for Large Colon Polyps

Start date: September 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.

NCT ID: NCT03361904 Completed - Colon Cancer Clinical Trials

Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age

Start date: January 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice. Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).

NCT ID: NCT03346005 Completed - Colorectal Cancer Clinical Trials

Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)

Start date: November 9, 2017
Phase: N/A
Study type: Interventional

The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.

NCT ID: NCT03344055 Completed - Colonoscopy Clinical Trials

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

Cuff-Bercy
Start date: November 15, 2017
Phase: N/A
Study type: Interventional

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy. This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

NCT ID: NCT03309683 Completed - Bleeding Clinical Trials

Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR)

CLIPPER
Start date: March 5, 2018
Phase: N/A
Study type: Interventional

Study design: A national, multi-center, patient-blinded, randomized clinical trial. Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing Delayed Bleeding (DB). Intervention: PC will be compared to standard care (no PC). Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma recurrence and risk factors for DB.

NCT ID: NCT03272945 Completed - Colonic Polyp Clinical Trials

Linked-color Imaging for the Detection of Colorectal Flat Lesions

Start date: September 6, 2017
Phase: N/A
Study type: Interventional

Linked color imaging (LCI) was recently developed and uses a laser endoscopic system (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new image-enhancing technology that is intended to enhance slight color differences in the red region of the mucosa. The acquired color information is reallocated to differentiate colors that are similar to the mucosal color, resulting in improved performance in depicting blood vessels, and additional image processing that enhances color separation for red color permits clear visualization of red blood vessels and white pits. This modality may increase the detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels. In addition, it has been reported that LCI increases the visibility of colorectal flat lesions and contributes to improvement of the detection rate for these lesions. The primary aim of the current study was to compare the detection rate of colorectal flat lesions of LCI cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In addition, we prospectively compared LCI and WL with regard to the visibility of colorectal flat lesions found in this study.

NCT ID: NCT03179358 Completed - Polyp of Colon Clinical Trials

Clinical Trial Verifying C-REX LapAid and C-REX DMH/DMHC

Start date: September 29, 2016
Phase: N/A
Study type: Interventional

In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further. The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP (C-reactive protein)-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts quality of life negatively. Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure (C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters). The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful preclinical study encourages a clinical verification in patients undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking Procedure by use of C-REX LapAid and C-REX DMH/DMHC.