[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642104":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":31,"responsibleParty":54,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Rectal Indomethacin plus Papilary spay of Cold saline",null,"Intervention group: Rectal indomethacin( 100 mg suppository administered 30-60 minutes pre ERCP + cold saline irrigation (4 - 10°C, 250 mL, 2 min)",{"label":13,"type":10,"description":14,"interventionNames":10},"Rectal Indomethacin alone","Rectal indomethacin should be administered to the patient before 30 minutes ERCP procedure",[16],{"name":17,"affiliation":18,"role":19},"Mohan Dr Ramchandani, MD DM","Asian Institute of Gastroenterology","STUDY_DIRECTOR",[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA","CONTACT","04023378888","312","rajeshgoud761@gmail.com",{"name":28,"role":23,"phone":24,"phoneExt":29,"email":30},"Mohana Dr Prafullah, MD DNB","427","mona.prafullah@gmail.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Asian institute of Gastroenterology\u002FAIG Hospitals","RECRUITING","Hyderabad","Telangana","500079","India","IN",{"type":41,"coordinates":42},"Point",[43,44],78.45636,17.38405,{"lat":44,"lon":43},[47,50],{"name":48,"role":23,"phone":24,"phoneExt":49,"email":26},"Rajesh Goud Mr Maragoni, M.Pharm, MBA","531",{"name":51,"role":23,"phone":24,"phoneExt":52,"email":53},"Zaheer Nabi Dr Mohammed, MBBS, MD","102","zaheernabi1978@gmail.com",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mohan Ramchandani","Director","100642104","a-combination-of-rectal-indomethacin-and-cold-water-exposure-of-the-ampulla-after-ercp-is-superior-to-rectal-indomethacin-alone-in-reducing-the-incidence-of-post-ercp-pancreatitis--rct-100642104",false,"NCT07574970","A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT","A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF PEP","ERCP","Inclusion Criteria:\n\n1. Standard ERCP indication\n2. Consent given\n\nExclusion Criteria:\n\n1. Pregnancy and lactation\n2. Chronic calcific pancreatitis \u002F pancreatic divisum \u002F pancreatic head\n3. malignancy \u002F acute pancreatitis within 14 days of ERCP\n4. ERCP for biliary\u002Fpancreatic stent exchange or removal or prior biliary sphincterotomy\n5. Chronic kidney disease with GFR \\\u003C30 or acute kidney injury.\n6. Presence of rectal anomaly\n7. Active GI bleeding or high bleeding risk precluding NSAIDs;platelet \\\u003C50000\u002FL;INR \\>1.5 not correctable\n8. NSAID allergy\n9. Cirrhosis Child-Pugh C\n10. Temp instability or severe cardiopulmonary disease precluding cooling\u002Fshock risk.\n11. Sphincter of Oddi dysfunction (Type 3)","ALL","18 Years","60 Years",{"count":70,"type":71},150,"ESTIMATED","OBSERVATIONAL","Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin\u002Fdiclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE\u002FESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy\u002Finstrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP\n\n1. Rectal NSAIDs reduce but do not eliminate PEP.\n2. Cold-water ampullary cooling is biologically plausible but under-studied.\n3. First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.\n4. First study in Indian population.",[75],"Pancreas Disease","2026-06-10",{"date":78,"type":79},"2026-06-12","ACTUAL",{"date":81,"type":79},"2025-12-01",{"date":83,"type":71},"2026-12-30",{"name":5,"class":6},1]