[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649386":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":55,"collaborators":21,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":21,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":21,"overallStatus":79,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Clinique Bizet","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal catheter implantable pump","EXPERIMENTAL","Administration of the medicine via an intrathecal catheter connected to an implantable pump",[13,14],"Device: Intrathecal catheter connected to an implantable pump","Drug: Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Intrathecal catheter connected to an implantable pump","Epidural puncture (AL injection), followed by a lumbar puncture and collection of cerebrospinal fluid. Positioning of the catheter behind the spinal cord at the desired metameric level for the pancreas (T5-T7), and positioning of the pump in the flank or buttock.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections","Medications are administered via an intrathecal catheter connected to an implantable pump or via periodic injections; the patient is admitted to hospital with morphine (IV, PO, transdermal) discontinued on entry to the unit (the same applies to methadone). Depending on the condition of the patient's abdominal skin (stoma, multiple injections, etc.) and any foreseeable technical difficulties during MRI scanning (in the left or right lateral positions), the procedure is performed under fluoroscopy, with appropriate antibiotic prophylaxis, under local anaesthesia, epidural anaesthesia and light sedation. Product used, dosage and frequency:\n\nOpioids: μ and δ receptors: Morphine sulphate: 50 mg\u002Fml Ca++ channels: ziconotide: initial dose 0.5 µg\u002Fday Sodium channels: 1% ropivacaine As with a patient-controlled analgesia (PCA) system: Continuous infusion + bolus or sequential boluses Patient education on the use of the pump during their hospital stay.",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Bouchra BENKESSOU Chef de projet Recherche Clinique","CONTACT","+33 7 64 48 60 16","b.benkessou@hexagone-sante-paris.fr",[34,46,51],{"facility":35,"status":21,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":21},"Benkessou","Paris","75016","France","FR",{"type":41,"coordinates":42},"Point",[43,44],2.3488,48.85341,{"lat":44,"lon":43},{"facility":47,"status":21,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":48,"geoPoint":50,"contacts":21},"Bizet Clinic",{"type":41,"coordinates":49},[43,44],{"lat":44,"lon":43},{"facility":5,"status":21,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":54,"contacts":21},{"type":41,"coordinates":53},[43,44],{"lat":44,"lon":43},{"type":56,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100649386","evaluating-the-effectiveness-of-ait-in-the-treatment-of-pain-related-to-pancreatic-cancer-100649386",false,"NCT07733427","Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer","A Pilot Study Aimed at Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer","PIT","Inclusion Criteria:\n\nSubject aged over 20 years\n\n* Patient with histologically confirmed pancreatic carcinoma\n* Chronic cancer-related pain that is inadequately controlled by standard treatment or for whom analgesics are contraindicated.\n* EMO \\\u003C 120 mg\u002Fday Patients experiencing side effects: sedation, vomiting, constipation, or an allergy to morphine.\n* Signed informed consent\n* Participants affiliated with or eligible for a social security scheme\n* Agree to complete the various study questionnaires\n\nExclusion Criteria:\n\nPatients under the age of 20.\n\n* Contraindications to intratracheal analgesia\n* Acute respiratory infection\n* Uncontrolled coagulation disorder\n* Pregnancy or breastfeeding\n* Unable to comply with medical follow-up for the study.\n* Adults who are legally protected, under guardianship or under a conservatorship","ALL","20 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","The aim of this clinical trial is to assess the effectiveness of intratracheal analgesia on pain intensity in cancer patients, from the start of treatment up to 3 months. It will also investigate the safety of this technique. The main questions it seeks to answer are as follows:\n\nWhat is the impact on the use of opioid analgesics, and can this be measured? What is the quality of life? What is the quality of sleep, and can this be assessed? How does the patient's weight change? Is the patient satisfied? What is the patient's overall survival?\n\nThe researchers will assess the equivalent daily dose of morphine (mg\u002Fday) between enrolment and follow-up visits, as well as the number of patients requiring an escalation of analgesic treatment. Overall quality of life score measured using the ESAS questionnaire between enrolment and follow-up visits; satisfaction assessed using a numerical satisfaction scale (0-10); sleep quality assessed using the ISI questionnaire; and the tolerability and safety of the technique assessed by monitoring adverse events.\n\nEligible participants:\n\nFollowing implantation of the intrathecal pump, participants will have scheduled consultations at day 30, then at 3, 6, 9 and 12 months, with questionnaires to be completed.",[75,76,77,78],"Pancreatic Cancer Pain","Intrathecal Analgesic","Intrathecal Administration of the Drug","Pancreatic Carcinoma","NOT_YET_RECRUITING","2026-07-30",{"date":82,"type":83},"2026-07-31","ACTUAL",{"date":85,"type":69},"2026-06",{"date":87,"type":69},"2027-12",{"name":5,"class":6},3]