View clinical trials related to Barrett Esophagus.
Filter by:This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
Patients with Barrett's esophagus (BE) have a change in the lining of the esophagus. The normal one the lining of the esophagus changes to a lining similar to that of the intestine. The new mucosa has increased the risk of developing cancer. Usually this type of cancer is detected in a late phase and the patients' survival is low (less than 25% at 5 years). In daily practice, we strive to detect early cancerous lesions in order to treat them and cure them the patients. It has been widely demonstrated in BE patients that if cancer or precursor lesions are detected in an early phase, patients can be cured with endoscopic treatment. Endoscopic treatment of BE is based on endoscopic resection of the lesions / early cancer. After resection, patients have a 20-47% risk of developing cancer later in the remaining Barrett's esophagus. So there is a need to remove the remaining Barrett's mucosa that has not been resected. Several techniques can be used for removal of remaining BE: radiofrequency ablation, argon plasma, cryotherapy or endoscopic resection. The goal is to after resection of cancer and removal of residual Barrett's mucosa, a normal esophageal epithelium will cover the esophagus and dramatically reduce the risk for cancer development. The most widely used strategy for removal of residual Barrett's mucosa is radiofrequency ablation. It is an easy technique to perform, but it is hindered by some factors: 1) it requires several treatment sessions; 2) is associated with complications in 11% of patients, such as severe pain, bleeding, stricture and perforation 3) Barrett's mucosal glands may grow under the new epithelium after treatment; 4) there is no histological assessment of what is ablated; 5) there is a need for continuous follow-up; 6) it there are high costs associated with this strategy; 7) This approach may cause physical and physiological burdens on patients due to continuous follow-up and lack of complete histological assessment. Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables resection of lesions or cancer in one piece and has been used extensively along the gastrointestinal tract. Studies have showed good effect of ESD for neoplastic BE. Karolinska has a lot of experience with ESD and has one of the largest the cohorts of ESD on BE patients. ESD of BE can be associated with complications such as bleeding and perforation in 2-3% in most published studies and in less than 1% each in our series. Another complication that can occur is narrowing of the the esophagus during the healing process after ESD. That risk was historically high and increased with the increase in the size of the resected specimen. The high risk of crowding out was the main inhibiting factor the development of ESD in the esophagus. With the introduction of steroid therapy to prevent narrowing a paradigm shift was formed and the corresponding narrowing risk was drastically reduced to between 2-33% in according to the size of the resections. In our series of 132 ESDs on Barrett's esophagus, 103 cases corresponded resections up to 75% of the luminal(?) circumference of the esophagus, in these only 4/103 (3.9%) had strictures and all were successfully treated with endoscopic balloon dilatation. In the remaining 29 ESDs: included resection more than 75% of the luminal circumference. In these, there was narrowing in 10/29 cases, all patients was successfully treated with endoscopic treatment. So preventive measures and thorough follow-up are associated with good results and safety profile, even in large ESD on BE. Several years ago did not perform ESD for the treatment of BE, due to the need for skilled endoscopists and the potential the risks of this procedure such as bleeding, perforation and strictures. Full resection of the BE mucosa allows complete resection of all mucosa at risk, with complete histological assessment and virtually no risk of lesion presence in the margins or development of buried glands. It leads to complete removal of BE and may lead to the need for additional follow-up. With this study, we want to test the efficacy and safety of ESD for the removal of all Barrett's mucosa, instead of the more common approach of resection of Barrett's cancer followed by ablation of the remaining BE.
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken), as well as (4) additional clinical management and/or a therapeutic procedure(s) performed. The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. It is expected typically to be approximately 4 months given the systemic delays in scheduling and performing upper endoscopies and obtaining biopsy results. There is no a priori limit on the timeline for obtaining these data, but it is . anticipated that all data collection will be completed within 8 months of the availability of EsoGuard results.
Barrett's oesophagus is a pre-cancerous condition in which normal cells in the lining of gullet undergo cell changes and this increases the risk of developing adenocarcinoma (a type of cancer) of the gullet. This type of cancer is the 5th most common type of cancer in the UK. To minimise this risk of developing cancer, patients with Barret's oesophagus have regular gastroscopy (a small camera at the tip of the slim tube) every 2-5 years to detect early cancer cell changes. During the procedure, the whole of oesophagus is carefully inspected, and small tissue samples (biopsies) are taken from visible abnormal area within Barrett's oesophagus and sent to the lab to check for cell changes. This is called targeted biopsies. As the endoscopist cannot always tell during gastroscopy where cells are changing, biopsies from each quarter of the gullet (called quadrantic biopsies) are also taken to reduce the risk of pre-cancerous cells being missed. However, this process is time consuming and expensive as numerous biopsies are required. Recently, there has been a huge development in artificial intelligence (AI). One of these developments is the aid of computer to detect (called computer-aided detection - CAD) the abnormal cell changes within Barrett's during gastroscopy. This system has recently been trained and tested on videos and photos to prove that its performance is as good as expert endoscopists. This system has been already approved to use in the UK. However, this system needs to be tested further and incorporated into real life use to prove that the CAD is useful in detecting cell changes during gastroscopy for targeted biopsies and therefore, the random biopsies can be avoided. A sample of patients with Barrett's oesophagus will be invited to participate in this study. Participants will have a gastroscopy as part of their usual care for Barrett's oesophagus. Endoscopist will inspect Barrett's oesophagus using AI and will take both targeted biopsies if clinically deemed appropriate along with quadrantic biopsies. Participants will continue to receive usual care and no additional follow up or procedures will be required as part of the study.
Detections of goblet cells and dysplasia are crucial for diagnosis and determining the surveillance program of Barrett's esophagus (BE). However, the optimal biopsy numbers and their yield rates of intestinal metaplasia (IM) and dysplasia are still uncertain, especially in Asia. The aim of this study was to determine the optimal biopsy protocol of BE.
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral. The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.
Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.