Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT06355206
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Feces and blood samples from RAP patients will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2034-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of acute pancreatitis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Acute pancreatitis is diagnosed according to the revised Atlanta classification, which requires 2 of the 3 following criteria: (1) abdominal pain suggestive of pancreatitis, (2) serum amylase and/or lipase greater than 3 times the upper limit of normal, (3) and crosssectional imaging (CT or MRI) findings consistent with acute pancreatitis.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with different treatment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.'}, {'measure': 'Characteristics of acute pancreatitis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.'}, {'measure': 'Proportion of patients wtih pain in RAP patients', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'Collect relevant data through pain assessment scales which include severity, frequency, time of duration and other characteristics of pancreatic pain.'}, {'measure': 'Proportion of patients with chronic pancreatitis', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'Proportion of patients who developed chronic pancreatitis.'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'The level of quality of life in RAP patients is measured using the SF-36.'}, {'measure': 'Evaluation of psychological condition', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'The psychological condition of RAP patients is measured using DASS-21.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent acute pancreatitis', 'natural course', 'therapeutic effect'], 'conditions': ['Cohort Study', 'Recurrent Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:\n\nDoes endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?\n\nPatients will be closely followed and clinical information will be recorded.', 'detailedDescription': 'Acute pancreatitis is one of the most common causes of acute hospital admission, which is unpredictable and contributes to high health-care costs even death. Recurrent acute pancreatitis is defined as two or more discrete episodes of acute pancreatitis, and has an estimated annual incidence of 8-10 per 100 000. Cholelithiasis, alcohol and Hyperglyceremia are the most commonly recognized causes of acute pancreatitis. About 80% of RAP patients can be identified through routine investigations identify (include proper history, physical examination, CT, MRI, endoscopic ultrasound); however, in up to 20% of cases whose cause remains unclear are known as idiopathic RAP. For RAP patients with clear cause, removal of the cause can effectively reduce or prevent recurrence. For patients with idiopathic RAP, the treatment options are not clear and have been subject to debate. At present, the natural course, outcome and therapeutic effect of RAP is still not clear. Therefore, the prospective cohort can clarify the clinical characteristics of RAP more comprehensively and deeply and to accumulate evidence for treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients whti recurrent acute pancreatitis come from Changhai Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent acute pancreatitis.\n\nExclusion Criteria:\n\n* Unwilling or unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT06355206', 'acronym': 'NACRE', 'briefTitle': 'Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'NACRE20230306'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'recurrent acute pancreatitis', 'description': 'Recurrent acute pancreatitis is generally defined as a condition in which at least two well documented episodes of acute pancreatitis have occurred, with resolution of symptoms between each episode, and absence of morphological criteria for chronic pancreatitis.', 'interventionNames': ['Combination Product: endoscopic intervention, surgery or conservative treatment']}], 'interventions': [{'name': 'endoscopic intervention, surgery or conservative treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'Personal information and treatment of the enrolled subjects will be collected.', 'armGroupLabels': ['recurrent acute pancreatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lianghao Hu, M.D.', 'role': 'CONTACT', 'email': 'lianghao-hu@hotmail.com'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lianghao Hu, M.D.', 'role': 'CONTACT', 'email': 'lianghao-hu@smmu.edu.cn', 'phone': '+86-13817593520'}, {'name': 'Xiaoyu Zhou', 'role': 'CONTACT', 'email': 'xyzhou0116@163.com', 'phone': '+86-17721292061'}], 'overallOfficials': [{'name': 'Zhaoshen Li, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}