Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 7:21 AM
Study NCT ID:
NCT05772234
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2023-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1066}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-ESWL pancreatitis', 'timeFrame': '24 hours', 'description': 'Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.'}], 'secondaryOutcomes': [{'measure': 'Severity of pancreatitis', 'timeFrame': '1 month', 'description': 'Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.'}, {'measure': 'Incidence of other post-ESWL complications', 'timeFrame': '24 hours', 'description': 'Including bleeding, infection, steinstrasse, and perforation.'}, {'measure': 'Incidence of fluid overload', 'timeFrame': '24 hours', 'description': 'Including pulmonary or peripheral edema and congestive heart failure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic extracorporeal shock wave lithotripsy', 'post-ESWL pancreatits', 'intravenous hydration', "lactated Ringer's solution"], 'conditions': ['Pancreatitis, Chronic', 'Pancreatic Duct Stone']}, 'referencesModule': {'references': [{'pmid': '31863440', 'type': 'BACKGROUND', 'citation': 'Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.'}, {'pmid': '36517310', 'type': 'BACKGROUND', 'citation': 'Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sheth SG, Thiruvengadam NR, Thosani NC, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: summary and recommendations. Gastrointest Endosc. 2023 Feb;97(2):153-162. doi: 10.1016/j.gie.2022.10.005. Epub 2022 Dec 12. No abstract available.'}, {'pmid': '16481097', 'type': 'BACKGROUND', 'citation': 'Skolarikos A, Alivizatos G, de la Rosette J. Extracorporeal shock wave lithotripsy 25 years later: complications and their prevention. Eur Urol. 2006 Nov;50(5):981-90; discussion 990. doi: 10.1016/j.eururo.2006.01.045. Epub 2006 Feb 7.'}, {'pmid': '25251205', 'type': 'BACKGROUND', 'citation': 'Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24.'}, {'pmid': '31447280', 'type': 'BACKGROUND', 'citation': 'Tandan M, Nageshwar Reddy D, Talukdar R, Vinod K, Kiran SVVS, Santosh D, Gupta R, Ramchandani M, Lakhtakia S, Rakesh K, Manohar Reddy P, Basha J, Nabi Z, Jagtap N, Rao GV. ESWL for large pancreatic calculi: Report of over 5000 patients. Pancreatology. 2019 Oct;19(7):916-921. doi: 10.1016/j.pan.2019.08.001. Epub 2019 Aug 2.'}, {'pmid': '35085482', 'type': 'BACKGROUND', 'citation': 'Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.'}, {'pmid': '27311618', 'type': 'BACKGROUND', 'citation': "Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14."}, {'pmid': '29237204', 'type': 'BACKGROUND', 'citation': "Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13."}, {'pmid': '33740415', 'type': 'BACKGROUND', 'citation': 'Sperna Weiland CJ, Smeets XJNM, Kievit W, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Witteman BJM, da Costa DW, van Eijck BC, Schwartz MP, Romkens TEH, Vrolijk JM, Hadithi M, Voorburg AMCJ, Baak LC, Thijs WJ, van Wanrooij RL, Tan ACITL, Seerden TCJ, Keulemans YCA, de Wijkerslooth TR, van de Vrie W, van der Schaar P, van Dijk SM, Hallensleben NDL, Sperna Weiland RL, Timmerhuis HC, Umans DS, van Hooft JE, van Goor H, van Santvoort HC, Besselink MG, Bruno MJ, Fockens P, Drenth JPH, van Geenen EJM; Dutch Pancreatitis Study Group. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2021 May;6(5):350-358. doi: 10.1016/S2468-1253(21)00057-1. Epub 2021 Mar 19.'}, {'pmid': '21645639', 'type': 'BACKGROUND', 'citation': "Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12."}, {'pmid': '31383573', 'type': 'BACKGROUND', 'citation': 'Radadiya D, Devani K, Arora S, Charilaou P, Brahmbhatt B, Young M, Reddy C. Peri-Procedural Aggressive Hydration for Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis Prophylaxsis: Meta-analysis of Randomized Controlled Trials. Pancreatology. 2019 Sep;19(6):819-827. doi: 10.1016/j.pan.2019.07.046. Epub 2019 Jul 30.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to clarify whether aggressive intravenous hydration with lactated Ringer's solution could reduce the incidence of post-ESWL pancreatitis in patients with chronic pancreatitis.", 'detailedDescription': "Chronic pancreatitis (CP) is a disease caused by genetic and environmental factors that lead to progressive fibrosis of the pancreatic tissue, resulting in irreversible damage to the structure and function of the pancreas. The incidence of pancreatic duct stones in CP is as high as 90%. Stones can lead to pancreatic duct obstruction, pancreatic parenchymal hypertension and ischemia, inducing frequent abdominal pain and accelerating the decline of pancreatic function, therefore, removal of pancreatic duct stones is important for relieving CP symptoms. For large stones and complex stones, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) was recommended. Acute pancreatitis is the most common complication after P-ESWL with an incidence of 6.3-12.5%, which result in prolonged hospitalization, increased medical costs, and can be life-threatening.\n\nThere are few studies on the prevention of postoperative pancreatitis after P- ESWL. Only one prospective randomized controlled study found the role of NSAIDs in the prevention of acute pancreatitis after ESWL, and preoperative use of rectal indomethacin reduced post-ESWL pancreatitis from 12% to 9%. ERCP placement of pancreatic duct stent is one of the effective methods to prevent post-ERCP pancreatitis. However, studies have shown that pancreatic duct stenting before ESWL is not effective in preventing acute pancreatitis after P-ESWL. More research is needed in the prevention and treatment of pancreatitis after P-ESWL.\n\nThere have been more high-quality studies on the prevention of post-ERCP pancreatitis. In addition to NSAIDs, several prospective randomized controls have found that perioperative high-dose lactated Ringerolysis (LRS) hydration is effective in preventing acute pancreatitis after ERCP. In a meta-analysis, active hydration of LRS was found to reduce post-ERCP pancreatitis from 13% to 6%. Based on above findings, international guidelines recommend aggressive perioperative LRS hydration to reduce the risk of post-ERCP pancreatitis.\n\nPrevious studies have suggested various mechanisms leading to post-ERCP pancreatitis, including mechanical injury, chemical injury, hydrostatic injury, and infection. Given the potentially similar pathogenesis of postoperative pancreatitis, we propose to conduct a randomized controlled trial to investigate the efficacy of active hydration of lactated Ringer's solution for the prevention of post-ESWL pancreatitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients with chronic pancreatitis aged between18 and 85 years who were eligible for treatment with ESWL for pancreatic stones were eligible for enrolment.\n\nExclusion Criteria:\n\n1. Patients readmitted to the hospital for ESWL during the study period.\n2. Acute pancreatitis in the last 3 days.\n3. 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/ml or Ejection Fraction value\\<50% should be excluded.\n4. Respiratory insufficiency (pO2 \\< 60 mmHg or saturation \\< 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) \\<70% are excluded.\n5. Severe liver disease (cirrhosis, liver abscess).\n6. Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL.\n7. Hypotension (systolic blood pressure \\<90 mmHg or mean arterial pressure \\<70 mmHg).\n8. Hypo- or hypernatremia (serum Na+ levels \\< 130 or \\> 150 mmol/L).\n9. Pregnancy.\n10. Unwilling or unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT05772234', 'acronym': 'HYPER', 'briefTitle': "Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis", 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': "Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis: A Multicenter, Prospective, Randomized Clinical Trial", 'orgStudyIdInfo': {'id': 'HYPER20221204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aggressive hydration group', 'description': "Periprocedural hydration with intravenous 20 mL/kg lactated Ringer's solution within 60 min from the start of ESWL (first shockwave delivered), directly followed by 3 mL/kg per h for 8 h.", 'interventionNames': ['Drug: Lactated ringers solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restricted hydration group', 'description': 'Periprocedural hydration with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Lactated ringers solution', 'type': 'DRUG', 'description': "Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.", 'armGroupLabels': ['Aggressive hydration group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).', 'armGroupLabels': ['Restricted hydration group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Lianghao Hu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Baotou Medical College', 'class': 'OTHER'}, {'name': 'Shanghai Pudong New Area Gongli Hospital', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Yunnan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}