[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"barretts-esophagus-with-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:barretts-esophagus-with-dysplasia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,74,98,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100480004","seattle-biopsy-protocol-versus-wide-area-transepithelial-sampling-in-patients-with-barretts-esophagus-undergoing-surveillance-100480004",false,"NCT05530343","Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance","A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)","SWAT-BE","Inclusion Criteria:\n\nSurveillance Population\n\n* Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia\u002Findefinite for dysplasia with NDBE at last endoscopy can be included)\n* Barrett's esophagus (BE) length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age18-89 years\n* Life-expectancy of at least 2 years\n\nScreening Population\n\n* Undergoing endoscopy for screening of BE\n* BE length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age 18-89 years\n* Expected life-expectancy of at least 2 years\n\nPhysicians\n\n-All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.\n\nExclusion Criteria:\n\nSurveillance Population\n\n* BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of EET\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy\n\nScreening Population\n\n* BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy","ALL","18 Years","89 Years",{"count":21,"type":22},2298,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).\n\nBarrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.\n\nEndoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a 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.\n\nPatients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).\n\nPatients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.\n\nWhile both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.\n\nParticipants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.\n\nUp to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.",[28,29,30],"Barrett Esophagus","Barretts Esophagus With Dysplasia","Esophageal Adenocarcinoma",[32,30,33],"Barrett's Esophagus","Dysplasia","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2022-10-03",{"date":42,"type":22},"2026-06",{"name":44,"class":45},"University of Colorado, Denver","OTHER",14,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100460527","emr-versus-esd-for-barretts-neoplasia-100460527","NCT05276791","EMR Versus ESD for Barrett's Neoplasia","Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial","REMOVE-RCT","Inclusion Criteria:\n\n* Patients age: ≥ 18 years\n* Willingness to undergo both EMR or ESD\n* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation\n* BE with at least one visible lesion (\"target lesion\") with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee\n* Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study\n* Prior endoscopic resection is allowed\n\nExclusion Criteria:\n\n* Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee\n* Patients with HGD in at least one random biopsy, before inclusion (i.e. during endoscopy in the referring center \\\u003C3 months before imaging, or during imaging endoscopy)\n* History of esophageal surgery other than fundoplication\n* History of esophageal ablation therapy\n* In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site\n* Uncontrolled coagulopathy with INR \\>2.0, thrombocytopenia with platelet counts \\\u003C 50,000\n* Esophageal varix or varices\n* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines\n* Life expectancy \\\u003C2 years",{"count":56,"type":22},331,[25],"Rationale:\n\nThe optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity.\n\nObjective:\n\nThe investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus.\n\nStudy design:\n\nRandomized clinical trial\n\nStudy population:\n\nPatients with Barrett's esophagus and a visible lesion with dysplasia and\u002For early cancer. Suspicion for submucosal invasion is an exclusion criterion.\n\nIntervention:\n\nPatients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection.\n\nMain study endpoint:\n\nPrimary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.",[29,60,61],"Barrett Adenocarcinoma","Esophageal Cancer",[63,64],"Barrett's esophagus","Esophagheal adenocarcinom","2026-06-24",{"date":35,"type":38},{"date":68,"type":38},"2023-01-17",{"date":70,"type":22},"2028-12-01",{"name":72,"class":45},"St. Antonius Hospital",6,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":5},"100521611","assessment-of-a-minimally-invasive-collection-device-for-molecular-analysis-of-esophageal-samples-100521611","NCT06071845","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia","SOS4C","Inclusion Criteria:\n\n* Subjects with known or suspected Barrett's esophagus (BE) (cases)\n\n  * Patients between the ages of 18-90.\n  * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.\n  * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.\n  * Undergoing clinically indicated endoscopy.\n* Subjects without known history of BE (controls)\n\n  * Undergoing clinically indicated diagnostic endoscopy\n\nExclusion Criteria:\n\n* For subjects with or without known evidence of BE (on history or review of medical records)\n\n  * Pregnant or lactating females.\n  * Patients who are unable to consent.\n  * Patients with current history of uninvestigated dysphagia.\n  * History of eosinophilic esophagitis, achalasia.\n  * Patients on oral anticoagulation including Coumadin, Warfarin.\n  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients with history of known esophageal or gastric varices or cirrhosis.\n  * Patients with history of surgical esophageal resection for esophageal carcinoma.\n  * Patients with congenital or acquired bleeding diatheses.\n  * Patients with a history of esophageal squamous dysplasia.\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.","90 Years",{"count":84,"type":22},450,[25],"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\u002Fesophageal 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\u002FEAC 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\u002FEAC.",[28,29,88,30],"Barrett's Esophagus Without Dysplasia","2026-05-29",{"date":91,"type":38},"2026-06-02",{"date":93,"type":38},"2023-10-16",{"date":95,"type":22},"2027-06-01",{"name":97,"class":45},"Mayo Clinic",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100619380","multicenter-prospective-cohort-on-esophageal-endoscopic-submucosal-dissection-100619380","NCT07343869","Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection","Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice","FEO","Inclusion Criteria:\n\n* Adults (≥ 18 years old)\n* Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection\n* Patients managed in one of the participating centers\n* Patient who has received oral and written information about the study and has not objected to participation\n* Patients covered by a social security or health insurance scheme.\n\nExclusion Criteria:\n\n* Patient refusal after reading the information sheet\n* Patient under legal protection (guardianship, curatorship, court-ordered protection)\n* Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency\n* Patients previously included for another lesion in the same study\n* Pregnant or breastfeeding women.\n* Patient deprived of liberty.\n* Patient currently enrolled in another clinical trial.",{"count":107,"type":22},750,"5 Years","OBSERVATIONAL","In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis.\n\nSurgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers.\n\nAfter endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers.\n\nESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study.\n\nThis multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.",[112,113,114,29],"Superficial Esophageal Cancer","Oesophageal Adenocarcinoma","Oesophageal Squamous Cell Carcinoma",[116,117,118,119],"Endoscopic esophageal disection","Endoscopic resection","Endoscopic submucosal dissection","Curative resection","NOT_YET_RECRUITING","2026-01-07",{"date":123,"type":38},"2026-01-15",{"date":125,"type":22},"2026-02-01",{"date":127,"type":22},"2036-02-01",{"name":129,"class":45},"Société Française d'Endoscopie Digestive",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100497169","surveillance-vs-endoscopic-therapy-for-barretts-esophagus-with-low-grade-dysplasia-100497169","NCT05753748","Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia","A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)","SURVENT","Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND:\n\nMeets all the following criteria will be eligible for enrollment:\n\n1. Male or female, age ≥18 years,\n2. Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia,\n3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,\n4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician),\n5. Demonstrated ability to tolerate proton pump inhibitor (PPI) therapy based on patient self-report, and, Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.\n\nExclusion Criteria:\n\n1. Pregnancy;\n2. Prior endoscopic eradication therapy for Barrett's esophagus;\n3. History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;\n4. History of esophageal resection\u002Fesophagectomy\n5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;\n6. Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy;\n7. Esophageal varices or known portal hypertension; and\n8. Life expectancy of \\\u003C2 years as judged by the site investigator. \\* Presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Subjects with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology; those with high grade dysplasia or post-endoscopy esophageal adenocarcinoma pathology will exit the study after a 30-day safety follow up.",{"count":140,"type":22},680,[25],"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.\n\nTo 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.\n\nEndoscopic 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.\n\nWhile 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.\n\nBarrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and\u002For 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.\n\nThis 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.",[29,28,30],[28,30,33],"2025-11-18",{"date":147,"type":38},"2025-11-24",{"date":149,"type":38},"2023-01-24",{"date":151,"type":22},"2029-04-30",{"name":44,"class":45},23]