[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608515":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":163,"collaborators":166,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":27,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":27,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":27,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Rectal indometacin alone","ACTIVE_COMPARATOR","Participants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures.",[13,14],"Drug: Indometacin suppository","Drug: Normal Saline",{"label":16,"type":17,"description":18,"interventionNames":19},"Aggressive hydration with rectal Indometacin","EXPERIMENTAL","Participants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution.",[13,20],"Drug: Lactated ringers solution",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Indometacin suppository","Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL",[16,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Lactated ringers solution","Intravenous 20 mL\u002Fkg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL\u002Fkg per h for 8 h.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Normal Saline","Intravenous fluid infusion with normal saline (maximum of 1.5mL\u002Fkg per h or 3L per 24h)",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Liang-Hao Hu","CONTACT","+8613817593520","lianghao-hu@hotmail.com",[43,59,70,81,93,106,117,134,143,151],{"facility":44,"status":45,"city":46,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Baotou Medical College","RECRUITING","Baotou","China","CN",{"type":50,"coordinates":51},"Point",[52,53],109.84389,40.6516,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":58,"phoneExt":27,"email":27},"Tong Dang","+8613948823999",{"facility":60,"status":45,"city":61,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Peking Union Medical College Hospital","Beijing",{"type":50,"coordinates":63},[64,65],116.39723,39.9075,{"lat":65,"lon":64},[68],{"name":69,"role":39,"phone":27,"phoneExt":27,"email":27},"Ai-ming Yang",{"facility":71,"status":45,"city":72,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Hangzhou First People's Hospital","Hangzhou",{"type":50,"coordinates":74},[75,76],120.16142,30.29365,{"lat":76,"lon":75},[79],{"name":80,"role":39,"phone":27,"phoneExt":27,"email":27},"Xiao feng Zhang",{"facility":82,"status":45,"city":83,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"The Third Xiangya Hospital of Central South University","Hunan",{"type":50,"coordinates":85},[86,87],120.18021,32.92741,{"lat":87,"lon":86},[90],{"name":91,"role":39,"phone":92,"phoneExt":27,"email":27},"Xiao-Yan Wang","+8613974889301",{"facility":94,"status":95,"city":96,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"The First Hospital of Lanzhou University","NOT_YET_RECRUITING","Lanzhou",{"type":50,"coordinates":98},[99,100],103.83987,36.05701,{"lat":100,"lon":99},[103],{"name":104,"role":39,"phone":105,"phoneExt":27,"email":27},"Xun Li","+8613993138612",{"facility":107,"status":45,"city":108,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Qilu Hospital of Shandong University","Shandong",{"type":50,"coordinates":110},[111,112],120.48412,40.28464,{"lat":112,"lon":111},[115],{"name":116,"role":39,"phone":27,"phoneExt":27,"email":27},"Xiu-Li Zuo",{"facility":5,"status":45,"city":118,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Shanghai",{"type":50,"coordinates":120},[121,122],121.45806,31.22222,{"lat":122,"lon":121},[125,126,128,131],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"name":27,"role":39,"phone":27,"phoneExt":27,"email":127},"zhaoshen-li@hotmail.com",{"name":129,"role":130,"phone":27,"phoneExt":27,"email":27},"Zhao-Shen Li","PRINCIPAL_INVESTIGATOR",{"name":132,"role":133,"phone":27,"phoneExt":27,"email":27},"Liang-hao Hu","SUB_INVESTIGATOR",{"facility":135,"status":45,"city":118,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"Ruijin Hospital",{"type":50,"coordinates":137},[121,122],{"lat":122,"lon":121},[140],{"name":141,"role":39,"phone":142,"phoneExt":27,"email":27},"Duo-Wu Zou","+8613901617608",{"facility":144,"status":45,"city":118,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Shanghai Pudong New Area Gongli Hospital",{"type":50,"coordinates":146},[121,122],{"lat":122,"lon":121},[149],{"name":150,"role":39,"phone":27,"phoneExt":27,"email":27},"Li-Ping Ling",{"facility":152,"status":95,"city":153,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Yunnan University Affiliated Hospital","Yunnan",{"type":50,"coordinates":155},[156,157],121.26661,32.04909,{"lat":157,"lon":156},[160],{"name":161,"role":39,"phone":162,"phoneExt":27,"email":27},"Fubing Yu","+8615808875292",{"type":130,"investigatorFullName":164,"investigatorTitle":165,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Zhaoshen Li","Professor",[167,168,170,172,173,174,175,176,177],{"name":135,"class":6},{"name":169,"class":6},"LanZhou University",{"name":171,"class":6},"First People's Hospital of Hangzhou",{"name":44,"class":6},{"name":144,"class":6},{"name":60,"class":6},{"name":107,"class":6},{"name":82,"class":6},{"name":178,"class":6},"Affiliated Hospital of Yunnan University","100608515","indometacin-with-or-without-aggressive-intravenous-hydration-to-prevent-pancreatitis-after-pancreatic-extracorporeal-shock-wave-lithotripsy-100608515",false,"NCT07202559","Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy","Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial","Inclusion Criteria:\n\n* Patients with painful chronic pancreatitis eligible for P-ESWL treatment\n* Ages between 18-85 years\n* Providing informed consent\n\nExclusion Criteria:\n\n* Patients readmitted to the hospital for ESWL during the study period\n* contraindications to ESWL\n* Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP\\>100pg\u002Fml or Ejection Fraction value\\\u003C50% should be excluded\n* Respiratory insufficiency (pO2 \\\u003C 60 mmHg or saturation \\\u003C 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) \\\u003C70% are excluded\n* Patients receiving more than 1.5 mL\u002Fkg\u002Fh or 3 L\u002F24 h of intravenous fluids in the 24 h before ESWL\n* Hypotension (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C70 mmHg)\n* Hypo- or hypernatremia (serum Na+ levels \\\u003C 130 or \\> 150 mmol\u002FL)\n* Severe liver disease (cirrhosis with ascites, liver abscess)\n* receiving NSAIDs within 7 days\n* Contraindications for rectal use of NSAIDs (renal dysfunction with serum creatinine \\>120 μmol\u002FL, allergy, active gastrointestinal bleeding, ulcer disease, and NSAID use for other indications \\[other than cardioprotective aspirin\\])\n* presence of coagulopathy or received anticoagulation therapy within 3 days\n* acute pancreatitis within 3 days\n* known active cardiovascular or cerebrovascular disease\n* pregnant or breastfeeding women\n* without a rectum (ie, status post-total proctocolectomy)","ALL","18 Years","85 Years",{"count":190,"type":191},1250,"ESTIMATED","INTERVENTIONAL",[194],"NA","This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.\n\nThe study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.\n\nThe trial will be conducted at multiple centers, ensuring a broad and diverse patient population.\n\nThe primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.\n\nThis study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.",[197,198,199],"Pancreatitis, Chronic","Pancreatitis, Acute","Pancreatic Duct Stones","2026-04-08",{"date":202,"type":203},"2026-04-13","ACTUAL",{"date":205,"type":203},"2025-10-13",{"date":207,"type":191},"2027-12-01",{"name":5,"class":6},10]