[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520767":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ospedale V. Fazzi","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients affected by HCC induced by metabolic syndrome as unique risk factor","EXPERIMENTAL","Patients aged 18 years old and older, affected by HCC with MS (metabolic syndrome) as unique risk factor who comply with the criteria for bariatric surgery, will undergo liver resection and sleeve gastrectomy with minimally-invasive technique in the same surgical procedure",[13],"Procedure: Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients with HCC related to metabolic syndrome as unique risk factor","ACTIVE_COMPARATOR","Patients aged 18 years old and older, affected by HCC (hepatocellular carcinoma) with MS (metabolic syndrome) as unique risk factor who will undergo liver resection only",[19],"Procedure: Liver resection for HCC induced by metabolic syndrome",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome","Patients in the experimental arm will undergo liver resection for HCC and sleeve gastrectomy for MS during the same surgical procedure.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Liver resection for HCC induced by metabolic syndrome","Patients in the active comparator arm will undergo liver resection for HCC",[15],[32],{"name":33,"affiliation":34,"role":35},"Annarita Libia","Ospedale Vito Fazzi, Lecce","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","0039 0833335284","libiamd@me.com",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":40},"0039 0833335285",[44],{"facility":45,"status":26,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Ospedale Vito Fazzi","Lecce","73100","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],18.17244,40.35481,{"lat":54,"lon":53},[57,59],{"name":33,"role":38,"phone":58,"phoneExt":26,"email":40},"0039 083333524",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":33,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Doctor","100520767","liver-resection-and-simultaneous-sleeve-gastrectomy-for-ms-hcc-liress-100520767",false,"NCT06060847","Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)","Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)","LIRESS","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent\u002Fassent for the trial\n2. Be ≥ 18 years of age on day of signing informed consent.\n3. Have hepatocellular carcinoma with metabolic syndrome as unique risk factor\n4. Have an overall Child-Pugh score = A\n5. Be eligible for liver resection with laparoscopic or robotic technique\n6. Be eligible for bariatric surgery as defined below\n\n   * BMI ≥ 40 kg\u002Fm2\n   * BMI ≥ 35-40 kg\u002Fm2 with associated comorbidities\n   * BMI 30-35 kg\u002Fm2 and type 2 diabetes\n   * BMI 30-35 kg\u002Fm2 and arterial hypertension with poor control despite optimal medical therapy.\n\nExclusion Criteria:\n\n1. Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome\n2. Denial of the patient to undergo bariatric procedure\n3. Have BMI \\\u003C 30\n4. Have negative opinion of psychologic consultant\n5. Have an overall Child-Pugh score \\> 7\n6. Evidence of clinical significant portal hypertension as followed:\n\n   * esophageal varices\n   * gastric varices\n   * portal hypertensive gastropathy\n   * gastric vascular ectasia\n\nOf note: 1) Conversion to open surgery for any reason does not represent a reason of data exclusion from the analysis; 2) any type of hepatic resection, according to Brisbane classification, is included, also major hepatectomy requiring preoperative intervention to achieve adequate volume remnant","ALL","18 Years",{"count":73,"type":74},50,"ESTIMATED","INTERVENTIONAL",[77],"NA","Hepatocellular carcinoma (HCC) related to metabolic syndrome (MS) as unique risk factor is gradually overpassing the more common viral and alcohol etiology, becoming a global health issue. Liver surgery for metabolic syndrome-related HCC in this frail subset of patients constitute a challenge, due to high morbidity and mortality rate reported in literature, and contrasting results in term of oncologic outcome. The present multicentric prospective study aims to ascertain if the combination of sleeve gastrectomy and liver surgery in the same surgical procedure may have benefit in terms of reduced perioperative morbidity and prolonged Overall Survival and Recurrence Free Survival. Secondary outcome will be the evaluation of the consequences induced by sleeve gastrectomy on liver disease, in particular liver fibrosis evaluated in term of NFS score (Non-Alcoholic Fatty Liver Disease Fibrosis score), FIB-4 (Fibrosis-4 Index for Liver Fibrosis) score and Fibroscan transient elastography.",[80,81],"Carcinoma, Hepatocellular","Metabolic Syndrome",[83,84,85],"hepatocellular carcinoma","sleeve gastrectomy","morbid obesity","NOT_YET_RECRUITING","2023-12-18",{"date":89,"type":90},"2023-12-19","ACTUAL",{"date":92,"type":74},"2024-03-06",{"date":94,"type":74},"2032-03-06",{"name":5,"class":6},1]