[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laura Boer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100563054","local-levobupivacaine-for-pain-relief-after-endoscopic-submucosal-dissection-for-esophageal-lesions-100563054",false,"NCT06611176","Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions","Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial","BESD-RCT","Inclusion Criteria:\n\n* Patients age ≥18 years at time of consent\n* Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm\n* Scheduled for esophageal ESD\n* Informed consent\n\nExclusion Criteria:\n\n* Presence of multiple lesions requiring two or more separate endoscopic resections\n* History of esophageal surgery other than fundoplications\n* History of esophageal ablation therapy\n* History of radiotherapy of the esophagus\n* Esophageal varices\n* Prior endoscopic resection in the same area\n* Uncontrolled coagulopathy\n* Severe medical comorbidities precluding endoscopy\n* Allergy to LB or other amide-type local anaesthesia\n* Current regular use of opioids\n* Other aetiology causing pain similar to post-ESD pain\n* Inability to assess pain due to severe psychiatric or neurological disease\n* Insufficient command of Dutch language\n* Brugada syndrome\n* Incapacitated patients","ALL","18 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24],"NA","Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.",[27,28],"Endoscopic Submucosal Dissection","Levobupivacaine",[30,31,32,33],"endoscopic submucosal dissection","ESD","esophagus","analgesic","RECRUITING","2024-11-27",{"date":37,"type":38},"2024-12-02","ACTUAL",{"date":40,"type":38},"2024-10-24",{"date":42,"type":21},"2026-03-30",{"name":44,"class":45},"Laura Boer","OTHER",3,{"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":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100563636","focal-cryoballoon-ablation-for-malignant-dysphagia-100563636","NCT06618742","Focal Cryoballoon Ablation for Malignant Dysphagia","Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer","DYS-CBAS","Inclusion Criteria:\n\n* Age \\>18 years at time of consent\n* Histopathologically-confirmed esophageal \u002F gastroesophageal cancer\n* Patients in the palliative setting (with or without (future) systemic chemotherapy)\n* Dysphagia defined as a score of ≥2 (able to swallow only semi-solids)\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Alternative etiology for dysphagia\n* Inability to pass the ultraslim endoscope\n* Severe medical comorbidities precluding endoscopy\n* Uncorrected coagulopathy\n* Prior distal esophagectomy\n* Previous esophageal varices\n* Expected survival \\<6 weeks\n* Prior radiotherapy for esophageal cancer\n* T4b esophageal cancer\n* Incapacitated subjects\n* Pregnant or breastfeeding",{"count":56,"type":21},20,[24],"Rationale:\n\nDysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment. Current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely\u002F temporary symptom improvement. Recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. Moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. However, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. Secondly, cryo-immunologic data in patients with EC is lacking.\n\nObjective:\n\n1. To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed.\n2. To evaluate the effect of cryoballoon ablation on host's anti-tumor response. Study design: Pilot study, Multi-center Prospective Uncontrolled Intervention\n\nStudy Study population: Adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma Intervention (if applicable): Focal cryoballoon ablation of visible tumor during an upper endoscopy. Cryoballoon ablation will be performed for two cycles of 12 seconds. In total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient.\n\nMain study parameters\u002Fendpoints:\n\n* \\- Feasibility of cryoballoon ablation defined as technical success of the procedure\n\n  * Safety based on incidence of procedure-related serious adverse events\n  * Efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor\n* Host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples",[60,61,62],"Dysphagia","Esophageal Cancer","Cryotherapy",[64],"cryoballoon ablation","2024-09-27",{"date":67,"type":38},"2024-10-01",{"date":69,"type":38},"2024-06-24",{"date":71,"type":21},"2025-12-31",{"name":44,"class":45},1,""]