[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"French Society of Digestive Endoscopy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100590294","g-poem-for-glycemic-control-in-diabetic-gastroparesis-100590294",false,"NCT06965543","G-POEM for Glycemic Control in Diabetic Gastroparesis","Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis","DIAPOEM","Inclusion Criteria:\n\n* Aged 18 to 90 years;\n* Diagnosed with diabetes for at least 5 years and be treated with optimized insulin therapy;\n* Severe gastroparesis with gastric retention \\>20% at 4h (confirmed by scintigraphy);\n* Failure of conventional gastroparesis treatment;\n* Continuous glucose monitoring (CGM) in use or willingness to use during study\n* Time in range (70-180 mg\u002FdL) \\\u003C70%\n\nExclusion Criteria:\n\n* Are treated with an automated insulin therapy system (closed-loop);\n* Have previously undergone gastric neurostimulation therapy with Enterra (Medtronic ©);\n* Have been treated with erythromycin in the past three months;\n* Do not provide informed consent;\n* Are pregnant or breastfeeding during the study period;\n* Are under legal guardianship;\n* Have contraindications to the POEM procedure, including contraindications to anesthesia and\u002For active anticoagulation that cannot be paused;\n* Have severe chronic constipation, defined by a Cleveland score \\>15 (Agachan et al., Dis Colon Rectum, 1996);\n* Have a history of esophagogastric surgery (excluding anti-reflux surgery), including esophagogastric resection or any type of bariatric surgery;\n* Have chronic intestinal pseudo-obstruction;\n* Have a clinical suspicion of chronic mesenteric ischemia, indicated by severe malnutrition, postprandial pain, and signs of digestive atherosclerosis;\n* Refuse to share CGM data via the Libre Link platform;\n* Plan or undergo changes in antidiabetic therapy or insulin delivery systems during the study period;\n* Are being treated with any gastric-emptying delaying agents, including GLP-1 receptor agonists;\n* Are undergoing treatment with ascorbic acid during the study;\n* Have not previously attempted therapy with at least one prokinetic drug;\n* Are actively treated with opioids;\n* Have had prior pyloromyotomy or pyloroplasty;\n* Have known eosinophilic gastroenteritis;\n* Have an organic obstruction of the pylorus or intestinal tract (e.g., fibrotic stenosis);\n* Have a severe coagulopathy;\n* Have esophageal or gastric varices and\u002For portal hypertension gastropathy;\n* Have decompensated liver cirrhosis (Child B or Child C);\n* Have an active gastroduodenal ulcer;\n* Have active cancer or precancerous conditions of the stomach or duodenum (dysplasia, gastric cancer, GIST).\n* Have a known medical condition that, in the investigator's opinion, could interfere with the study protocol;\n* Have experienced diabetic ketoacidosis requiring hospitalization within six months prior to enrollment;\n* Have had a severe hypoglycemic episode requiring hospitalization within six months prior to enrollment.","ALL","18 Years","90 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.",[28],"Gastroparesis",[30,28,31],"G-POEM (Gastric Per Oral Endoscopic Myotomy)","diabetic gastroparesis","NOT_YET_RECRUITING","2025-05-02",{"date":35,"type":36},"2025-05-11","ACTUAL",{"date":38,"type":22},"2025-07",{"date":40,"type":22},"2028-07",{"name":42,"class":43},"French Society of Digestive Endoscopy","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100573215","pilot-study-of-eus-guided-radiofrequency-and-folfirinox-in-advanced-pancreatic-cancer-radiofap--100573215","NCT06743386","Pilot Study of EUS-Guided Radiofrequency and FOLFIRINOX in Advanced Pancreatic Cancer (RadioFAP )","Pilot Study Evaluating the Combination of Endoscopic Ultrasound-Guided Radiofrequency and FOLFIRINOX in Locally Advanced Pancreatic Cancer","RadioFAP","Inclusion Criteria:\n\n1. Patients over the age of 18\n2. Patients with locally advanced, borderline resectable, or inoperable pancreatic adenocarcinoma, confirmed by histological or cytological tests and assessed through a multidisciplinary consultation.\n3. Patients without evidence of metastases.\n4. No prior anti-tumoral treatment.\n5. World Health Organization (WHO) performance status ≤ 1.\n6. Measurable tumor according to the RECIST v1.1 criteria: a tumor lesion with the largest diameter ≥ 20 mm using conventional imaging techniques or ≥ 10 mm using spiral CT scan.\n7. Patient who has provided written consent.\n8. Patient with no contraindications to general anesthesia.\n9. Pancreatic tumor accessible via endoscopic ultrasound.\n10. Patient enrolled in a social security program (beneficiary or dependent).\n\nExclusion Criteria:\n\n* 1\\. Other types of non-ductal or solid pancreatic tumors, including endocrine tumors, acinar cell adenocarcinoma, cystadenocarcinoma, and malignant ampullary tumors.\n\n  2\\. Presence of metastases. 3. Contraindication to treatment with 5FU, oxaliplatin, or irinotecan. 4. Patients with a tumor that could benefit from neoadjuvant treatment with radiochemotherapy or chemotherapy alone for secondary resection (decision by a multidisciplinary committee).\n\n  5\\. Pre-existing neuropathy, Gilbert's disease, or known UGT1A1\\*28\u002F\\*28 genotype. 6. Chronic inflammatory bowel disease. 7. Other concurrent cancers, or a history of cancer within the last 5 years, except for in situ cervical cancer that has been treated or a properly treated basal cell carcinoma or squamous cell carcinoma.\n\n  8\\. Hereditary intolerance to fructose. 9. Individuals deprived of liberty or under guardianship. 10. Inability to follow up with the study due to geographical, social, or psychological reasons.\n\n  11\\. Contraindication to echo-endoscopy-guided cytopuncture (coagulation disorders or previously operated stomach).\n\n  12\\. Neutrophil count \\\u003C 1500\u002Fmm³. 13. Platelet count \\\u003C 70,000\u002Fmm³. 14. Patients are not effectively treated for neoplastic jaundice if present at diagnosis.\n\n  15\\. Patient in an exclusion period or currently participating in another clinical research protocol.\n\n  16\\. Patients are unable to understand or read the information\u002Fconsent form. 17. Pregnant women or those wishing to become pregnant during the study period, or breastfeeding women.\n\n  18\\. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs).",{"count":53,"type":22},30,[25],"Pancreatic adenocarcinoma (PDAC) constitutes 90% of pancreatic tumors and is projected to become the second leading cause of cancer-related mortality in Europe by 2030. In France, its incidence doubled in men and tripled in women between 1982 and 2012. PDAC remains the digestive cancer with the poorest prognosis, with a five-year overall survival rate below 10% across all stages. Only surgical management with R0 resection (surgical margins free of cancer cells) offers a chance for cure or prolonged survival. However, surgery is feasible in only 15% of patients, as the disease is typically diagnosed at a late stage-locally advanced in 35% of cases or metastatic in 50%. Chemotherapy, specifically FOLFIRINOX, is the standard treatment for advanced cases, but resistance to chemotherapy poses a significant challenge. A key contributor to this resistance is the tumor stroma, which constitutes most of the tumor mass. This fibrous tissue acts as a mechanical barrier, restricting blood flow and potentially limiting the delivery of chemotherapy to cancer cells. The development of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has shown promise in treating pancreatic neuroendocrine tumors (pNETs) and pancreatic cystic neoplasms, sparking interest in its potential for PDAC. Preliminary studies demonstrate the feasibility of radiofrequency in PDAC, showing increased blood flow around treated sites. Combining systemic chemotherapy with radiofrequency may enhance drug diffusion and improve treatment efficacy. Additionally, tumor thermoablation could stimulate an immune response, as observed in experimental and clinical research. This study aims to evaluate the feasibility of tumor destruction via radiofrequency ablation combined with FOLFIRINOX in improving progression-free survival for patients with PDAC.",[57],"Pancreatic Adenocarcinoma",[59,60,61],"EUS-Guided Radiofrequency Ablation (RFA)","Pancreatic Tumor Ablation","Minimally Invasive Tumor Treatment","2025-03-10",{"date":64,"type":36},"2025-03-11",{"date":66,"type":22},"2025-04",{"date":68,"type":22},"2027-08",{"name":42,"class":43},""]