[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626914":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":85,"studyPopulation":76,"armGroups":86,"interventions":98,"overallOfficials":108,"centralContacts":113,"locations":119,"responsibleParty":179,"collaborators":76,"id":183,"slug":76,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":184,"sex":190,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":76,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":122,"whyStopped":76,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Percent change in body weight","Body weight (in kg) will be measured at baseline and again at 3 months follow-up, and the difference between the two time points will be used to assess the effect of the intervention on patients' weight status. The change will be expressed as percent change of weight 3 months compared to baseline weight.","3 months",[14,17,20,23,26,29,32,35,38,40,42,44,47,49,51,54],{"measure":15,"description":16,"timeFrame":12},"Change in quality of life","Quality of life will be assessed by the Short Form (SF)-36 tool. This is a standardised and validated questionnaire based scoring tool that contains 36 questions dealing with 8 domains of quality of life.\n\nThe lowest score in this tool is 0 and the highest score is 100, a higher score indicating better quality of life.",{"measure":18,"description":19,"timeFrame":12},"Change in pancreatic exocrine function","Exocrine function will be assessed by the Fecal elastase test and will be expressed as microgram of elastase per gram of stool. Higher value indicates better exocrine function. The cut-off value that will be used is 200mcg\u002Fgm elastase, below which exocrine insufficiency will be considered to be present.",{"measure":21,"description":22,"timeFrame":12},"Change in nutritional status: Subjective Global Assesment (SGA)","This is a semiquantitative questionnaire based nutritional assessment tool which classifies the nutritional status as SGA A (normal nutrition), SGA B (mild\u002Fmoderate malnutrition) and SGC C (severe malnutrition)",{"measure":24,"description":25,"timeFrame":12},"Change in nuritional status: Anthropometry","Skin fold thickness (in mm) over the triceps muscle at the mid arm level.",{"measure":27,"description":28,"timeFrame":12},"Change in nutritional change: Anthropometry","Mid-arm circumference (MAC) in cm.",{"measure":30,"description":31,"timeFrame":12},"Change in nutritional status: Anthropometry","Mid-upper arm muscle circumference (MAMC) in cm.",{"measure":33,"description":34,"timeFrame":12},"Change in nutritional status: Anthropomentry","Mid-arm muscle area (MAMA) in cm square.",{"measure":36,"description":37,"timeFrame":12},"Change in nutritional status: Biochemical assessment","Hemoglobin in gm\u002FdL",{"measure":36,"description":39,"timeFrame":12},"Serum prealbumin in mg\u002FdL",{"measure":36,"description":41,"timeFrame":12},"Vitamin D",{"measure":36,"description":43,"timeFrame":12},"Vitamin B12",{"measure":45,"description":46,"timeFrame":12},"Change in the endocrine status","Fasting blood glucose (FBS)",{"measure":45,"description":48,"timeFrame":12},"HbA1c",{"measure":45,"description":50,"timeFrame":12},"Stimulated C-peptide",{"measure":52,"description":53,"timeFrame":12},"Change in patient's impression of change after treatment","This will be evaluated using the Patient's Global Impression of Change (PGIC). The score ranges from 1-7, with a score of 1 indicating very much improved and 7 indicating very much worse",{"measure":55,"description":56,"timeFrame":12},"Readmission after onset of treatment","Readmission to hospital",[58,61,64,67,70],{"measure":59,"description":60,"timeFrame":12},"Change in body composition (Bioimpedence analysis): Body fat mass (kg)","Total body fat will be assessed using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body. The normal range is 10-20kg.",{"measure":62,"description":63,"timeFrame":12},"Change in body composition (Bioimpedence analysis): Skeletal muscle mass (kg)","Skeletal muscle mass will be assessed using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.",{"measure":65,"description":66,"timeFrame":12},"Change in body composition (Bioimpedence analysis): Total body water (litres)","Total body water will be quantified using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.",{"measure":68,"description":69,"timeFrame":12},"Change in body composition (Bioimpedence analysis): Phase angle at 50kH (degrees)","Cell membrane integrity will be assessed using the phase angle function of Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.",{"measure":71,"description":72,"timeFrame":12},"Change in body composition (Bioimpedence analysis): Visceral fat level (numerical unit; normal range (1-12).","Visceral fat level will be assessed using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body. The normal range is from 1-12, a loser value indicating lower visceral fat and higher value indicates larger visceral fat.",{"allocation":74,"interventionModel":75,"interventionModelDescription":76,"primaryPurpose":77,"observationalModel":76,"timePerspective":76,"maskingInfo":78},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":79,"maskingDescription":76,"whoMasked":80},"QUADRUPLE",[81,82,83,84],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Acute pancreatitis (AP), an inflammatory disorder of the pancreas, is mild and self-limiting in most patients. Around 10-20% of AP patients develop acute necrotizing pancreatitis (ANP) which is characterized by destruction of both pancreatic and peripancreatic tissue and is associated with high rate of morbidity and mortality due to both local and systemic complications.\n\nEarly recognition and close monitoring of affected patients is crucial. Treatment consists of goal-directed intravenous fluid resuscitation, pain control, and enteral nutrition as early as possible. While sterile necrosis might resolve with above conservative measures, infected necrosis requires antibiotics and further interventions such as percutaneous drainage, minimally invasive surgeries, and endoscopic necrosectomy.\n\nIn ANP patients there is direct destruction of acinar tissue that results in pancreatic exocrine insufficiency (PEI). In PEI there is insufficient secretion of pancreatic enzymes that causes inadequate nutrient digestion and absorption resulting in weight loss, malnutrition, metabolic bone disease and fat-soluble vitamins and mineral deficiencies. The risk of PEI after ANP is about 25% over 3 years. According to two meta-analysis, PEI was found to be more prevalent during the index AP episode and it remained persistent in about half of the study population at follow-ups. They also reported that the risk of developing PEI is more in those with alcoholic etiology and severe and necrotizing pancreatitis. Hence, management of PEI following ANP is important to improve nutritional status and quality of life. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment for PEI. While the use of PERT is well-established in chronic pancreatitis, its efficacy in patients with ANP is still unclear. Hence, in this study, the investigators aim to provide insights into the potential benefits of enzyme supplementation in patients with ANP by evaluating nutritional status, clinical outcomes, and quality of life.\n\nThis is a multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \\>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.\n\nThe primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.",[87,92],{"label":88,"type":89,"description":76,"interventionNames":90},"Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m","EXPERIMENTAL",[91],"Drug: Pancreatic enzyme capsules",{"label":93,"type":94,"description":95,"interventionNames":96},"Similar appearing glucose capsules will be provided three times a day along with food","PLACEBO_COMPARATOR","Drug: Placebo Similar appearing glucose capsules",[97],"Drug: Placebo",[99,104],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":76},"DRUG","Pancreatic enzyme capsules","Enteric coated pancreatic enzyme",[88],{"type":100,"name":105,"description":106,"armGroupLabels":107,"otherNames":76},"Placebo","Similar appearing glucose capsules",[93],[109],{"name":110,"affiliation":111,"role":112},"Rupjyoti Talukdar, MD","Asian Institute of Gastroenterology Hospitals","STUDY_DIRECTOR",[114],{"name":115,"role":116,"phone":117,"phoneExt":76,"email":118},"Abdul Rasheed, PharmD","CONTACT","+919652104726","abdulrasheedmd1223@gmail.com",[120,139,153,164],{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"Gauhati Medical College","RECRUITING","Guwahati","Assam","781032","India","IN",{"type":129,"coordinates":130},"Point",[131,132],91.7458,26.1844,{"lat":132,"lon":131},[135],{"name":136,"role":116,"phone":137,"phoneExt":76,"email":138},"Mallika Bhattacharyya, MD","+918135848141","mallikabhattacharyya@gmail.com",{"facility":140,"status":122,"city":141,"state":142,"zip":143,"country":126,"countryCode":127,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Asian Institute of Gastroenterology Hospitals, Gachibowli","Hyderabad","Telangana","500032",{"type":129,"coordinates":145},[146,147],78.45636,17.38405,{"lat":147,"lon":146},[150],{"name":110,"role":116,"phone":151,"phoneExt":76,"email":152},"+917032804231","rup_talukdar@yahoo.com",{"facility":154,"status":122,"city":141,"state":142,"zip":155,"country":126,"countryCode":127,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Asian Institute of Gastroenterology, Banjara Hills","500082",{"type":129,"coordinates":157},[146,147],{"lat":147,"lon":146},[160],{"name":161,"role":116,"phone":162,"phoneExt":76,"email":163},"Jahangeer Basha, DM","9000199577","dr.jahangeer@aighospitals.com",{"facility":165,"status":122,"city":166,"state":167,"zip":168,"country":126,"countryCode":127,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"ILS Hospital, Dum Dum","Kolkata","West Bengal","700080",{"type":129,"coordinates":170},[171,172],88.36304,22.56263,{"lat":172,"lon":171},[175],{"name":176,"role":116,"phone":177,"phoneExt":76,"email":178},"Sanjay Banerjee, DM","+919830129866","drsanjaygastro@gmail.com",{"type":180,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":76,"oldOrganization":76},"PRINCIPAL_INVESTIGATOR","Rupjyoti Talukdar","Director, Pancreatology, AIG Hospitals","100626914",false,"NCT07441824","Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis","Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial","PERiANP","Inclusion Criteria:\n\n* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria\n* Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening\n* Within 6 weeks of onset of disease\n* Able to take food orally\n* Age 18-60 years\n* Both genders\n\nExclusion Criteria:\n\n* Underlying chronic pancreatitis\n* Recurrent acute pancreatitis\n* Pancreatic cancer\n* Patients being discharged with NJ tubes\n* Pregnancy and lactation\n* Inability to give informed consent.","ALL","18 Years","60 Years",{"count":194,"type":195},140,"ESTIMATED","INTERVENTIONAL",[198],"PHASE3","In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \\>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.\n\nThe primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.",[201,202],"Acute Necrotizing Pancreatitis","Pancreatic Exocrine Insufficiency",[204,205,206],"acute pancreatitis","pancrearic exocrine insufficiency","pancreatic enzyme replacement therapy","2026-04-29",{"date":209,"type":210},"2026-05-05","ACTUAL",{"date":212,"type":210},"2026-04-10",{"date":214,"type":195},"2027-06",{"name":5,"class":6},4]