Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-29 @ 12:20 AM
Study NCT ID:
NCT05498961
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of severity of GSP patients', 'timeFrame': '1 month', 'description': 'Based on the 2012 Atlanta International Consensus, Mild acute pancreatitis (MAP) is defined as no organ failure and no local or systemic complications. Moderate to severe acute pancreatitis (MSAP) refers to patients with organ failure, local complications, or aggravated complications. Severe acute pancreatitis (SAP) is defined as persistent organ failure for more than 48 hours.'}], 'secondaryOutcomes': [{'measure': 'Modified computed tomography severity index (MCTSI) score', 'timeFrame': '1 month', 'description': 'Without knowing the prognosis, two radiologists with eight and ten years of experience independently scored the severity of GSP through the MCTSI score and reached an agreement through discussion when there was disagreement.'}, {'measure': 'Gallstone size', 'timeFrame': '1 month', 'description': 'The diameter of the stones'}, {'measure': 'Number of stones', 'timeFrame': '1 month', 'description': 'The number of gallstones'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatitis', 'Gallstone', 'Severity'], 'conditions': ['Acute Gallstone Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '23622135', 'type': 'BACKGROUND', 'citation': 'Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.'}, {'pmid': '32891214', 'type': 'BACKGROUND', 'citation': 'Boxhoorn L, Voermans RP, Bouwense SA, Bruno MJ, Verdonk RC, Boermeester MA, van Santvoort HC, Besselink MG. Acute pancreatitis. Lancet. 2020 Sep 5;396(10252):726-734. doi: 10.1016/S0140-6736(20)31310-6.'}, {'pmid': '38813815', 'type': 'DERIVED', 'citation': 'Ma Y, Yue P, Zhang J, Yuan J, Liu Z, Chen Z, Zhang H, Zhang C, Zhang Y, Dong C, Lin Y, Liu Y, Li S, Meng W. Early prediction of acute gallstone pancreatitis severity: a novel machine learning model based on CT features and open access online prediction platform. Ann Med. 2024 Dec;56(1):2357354. doi: 10.1080/07853890.2024.2357354. Epub 2024 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)', 'detailedDescription': 'The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acute gallstone pancreatitis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute gallstone pancreatitis (GSP) patients.\n\nExclusion Criteria:\n\n* Pancreatitis with bile duct stones, trauma, drugs, and surgery;\n* Recurrent gallstone pancreatitis;\n* Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma;\n* Previous hepatobiliary and pancreatic surgery, Organ transplantation;\n* Intestinal obstruction or other obstructive diseases;\n* Chronic pancreatitis or pancreatic duct stones;\n* Thrombotic disease;\n* Alcoholic pancreatitis and hyperlipidemia pancreatitis.'}, 'identificationModule': {'nctId': 'NCT05498961', 'briefTitle': 'The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis', 'orgStudyIdInfo': {'id': 'acute gallstone pancreatitis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gallstone characteristics', 'type': 'OTHER', 'description': 'stone size, number, the thickness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}], 'overallOfficials': [{'name': 'Wenbo Meng, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LanZhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If patients permitted'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}