[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599146":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":55,"studyPopulation":19,"armGroups":56,"interventions":68,"overallOfficials":19,"centralContacts":77,"locations":87,"responsibleParty":107,"collaborators":19,"id":111,"slug":19,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":19,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":19,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":90,"whyStopped":19,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"Length of hospital stay after debridement","The total length of hospital stay after debridement, including readmissions.","From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)",{"measure":14,"description":15,"timeFrame":12},"Degree of pancreatic sinistral portal hypertension","The degree of pancreatic sinistral portal hypertension after intervention",[17,21,24,26,28,30,32,34,36,38,41],{"measure":18,"description":19,"timeFrame":20},"Intensive Care Unit stay post Operation",null,"Perioperative",{"measure":22,"description":23,"timeFrame":20},"Pancreatic Fistula","The rate of pancreatic fistula",{"measure":25,"description":19,"timeFrame":20},"Number of Draining Tube when Discharged",{"measure":27,"description":19,"timeFrame":12},"Time of all draining tubes removal",{"measure":29,"description":19,"timeFrame":20},"Cost post debridement in the first hospitalization",{"measure":31,"description":19,"timeFrame":12},"Number of unplanned re-admissions",{"measure":33,"description":19,"timeFrame":12},"Number of unplanned operations",{"measure":35,"description":19,"timeFrame":12},"Number of percutaneous drainage after debridement",{"measure":37,"description":19,"timeFrame":20},"Antibiotic use after treatment",{"measure":39,"description":40,"timeFrame":20},"Abdominal lavage","Abdominal lavage volume after treatment",{"measure":42,"description":43,"timeFrame":44},"Life quality one year after treatment","Life quality one year after treatment was judged by the Short-Form 36 Health Survey (SF-36), encompassing both physical and mental health across eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The minimum value is 0%, the maximum value is 100%, and a higher score means a better life quality.","Within one year after the last subject was treated",[46],{"measure":47,"description":19,"timeFrame":44},"Platelet number after debridement",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":19,"timePerspective":19,"maskingInfo":53},"RANDOMIZED","PARALLEL","One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.","TREATMENT",{"masking":54,"maskingDescription":19,"whoMasked":19},"NONE","This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"Splenectomy group","EXPERIMENTAL","Open Debridement combined with Distal Pancreatectomy and Total Splenectomy",[62],"Procedure: Splenectomy",{"label":64,"type":59,"description":65,"interventionNames":66},"Control group","Open Debridement alone",[67],"Procedure: Control",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":19},"PROCEDURE","Splenectomy","Open Debridement combined with distal pancreatectomy and total splenectomy",[58],{"type":70,"name":75,"description":65,"armGroupLabels":76,"otherNames":19},"Control",[64],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":19,"email":82},"Yun Zhang","CONTACT","086-18058715288","bigzyun1977@zju.edu.cn",{"name":84,"role":80,"phone":85,"phoneExt":19,"email":86},"Jian Zhang","086-18758197996","johnzhang@zju.edu.cn",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":97,"coordinates":98},"Point",[99,100],120.16142,30.29365,{"lat":100,"lon":99},[103],{"name":104,"role":80,"phone":105,"phoneExt":19,"email":106},"Ting-Bo Liang","086-571-87236688","liangtingbo@zju.edu.cn",{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","TingBo Liang","Director physician","100599146",false,"NCT07080697","A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension","The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension","Inclusion Criteria:\n\n1. Age between 18 and 75 years.\n2. Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.\n3. Patients undergoing open debridement for infected pancreatic necrosis\n\nExclusion Criteria:\n\n1. Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).\n2. Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.\n3. Patients with pre-existing hematological diseases prior to AP.\n4. Patients undergoing laparoscopic or nephroscopic debridement.","ALL","18 Years","75 Years",{"count":121,"type":122},66,"ESTIMATED","INTERVENTIONAL",[125],"NA","This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.",[128,129],"Acute Necrotizing Pancreatitis","Portal Hypertension",[128,131,132,71],"Pancreatic Sinistral Portal Hypertension","Debridement","2025-07-20",{"date":135,"type":136},"2025-07-23","ACTUAL",{"date":138,"type":122},"2025-07-30",{"date":140,"type":122},"2028-02-29",{"name":5,"class":6},1]