Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-04-05 @ 11:50 AM
Study NCT ID:
NCT02002793
Status:
UNKNOWN
Last Update Posted:
2013-12-06
First Post:
2013-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-01', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-12-01', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of ACS in 28 days since outbreaks', 'timeFrame': '28 days', 'description': "Time of first attacks of these situations that have to be surgically interfered in 28 days since onsets: ACS or pancreatic necrosis, abdominal hemorrhage, pancreatic abscess or pancreatic pseudocyst which brings symptoms or complications or increase in size;rates of organs' dysfunction, abdominal infection and reuse of drainage;"}], 'secondaryOutcomes': [{'measure': 'Rates of surgical interfere, MODS or death in 6 months since outbreaks', 'timeFrame': '6 months', 'description': "Rates of mortality or organs' dysfunction; rates of complications, including: pancreatic leakage, pancreatic pseudocysts in need of surgical interfere, pancreatic abscess, bile duct stricture and pancreatic insufficiency; times of surgery, hospital stay, time in ICU and hospitalization expense;"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatitis', 'early stage', 'mini-invasive abdominal drainage'], 'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': 'This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion.', 'detailedDescription': "Pancreatitis associated ascetic fluids(PAAF) gather with the beginning of SAP and induced IAP(intra-abdominal pressure) increasement.With an excess of 12mmHg ,IAP presents as IAH(intra-abdominal hypertension) and when a ≥20mmHg IAP accompanied with at least one organ's dysfunction it is ACS(abdominal compartment syndrome).Previous recommended theraphy of ACS is laparotomy.However,with inherited advantages such as ease-to-operate and minimal invassiveness, early stage mini-invasive abdominal drainage therapies , for example, percutaneous catheter drainage(PCD) instructed by ultrasound or CT ,have shown a promised future in recent years. It is reported that patients acquired PCD decreased 81% in operation rate compared to those who did not and had lower mortality rate. Whereas, the operation flow of early stage mini-invasive abdominal drainage remains controversial, and whose validity calls for evidence from large-scale clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1.Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta criteria revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection\n\n\\-\n\nExclusion Criteria:\n\n1.Pregnancy 2.Heart function: NYHA \\>II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy \\< 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure\\>25cmH2O 9.At least one organ'S newly emerged dysfunction\n\n\\-"}, 'identificationModule': {'nctId': 'NCT02002793', 'briefTitle': 'Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP', 'orgStudyIdInfo': {'id': 'SAP bundle-abdominal drainage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Early stage abdominal drainage', 'description': 'SAP patients who matches one of the following criteria:1．Intravesical pressure≥20cmH2O or 2.CT images:acute peripancreatic liquid collection should have early stage abdominal drainage immediately;', 'interventionNames': ['Other: Early stage abdominal drainage']}, {'type': 'OTHER', 'label': 'Late stage abdominal drainage', 'description': 'Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT images:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis;', 'interventionNames': ['Other: Late stage abdominal drainage']}], 'interventions': [{'name': 'Early stage abdominal drainage', 'type': 'OTHER', 'description': 'Ultrasound/CT/GUS guided abdominocentesis and drainage with single-chamber deep venous catheters shoule be implemented and the catheter should be removed when abdominal drainage flow≤100ml in two successive days;', 'armGroupLabels': ['Early stage abdominal drainage']}, {'name': 'Late stage abdominal drainage', 'type': 'OTHER', 'description': 'Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT scan:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis;', 'armGroupLabels': ['Late stage abdominal drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'erzhen Chen, PhD', 'role': 'CONTACT', 'email': 'chenerzhen@hotmail.com', 'phone': '66370045', 'phoneExt': '665520'}], 'facility': 'Ruijin', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'erzhen Chen, PhD', 'role': 'CONTACT', 'email': 'chenerzhen@hotmail.com', 'phone': '64370045', 'phoneExt': '665520'}, {'name': 'enqiang Mao, PhD', 'role': 'CONTACT', 'email': 'maoenqiang@hotmail.com', 'phone': '64370045', 'phoneExt': '665520'}], 'overallOfficials': [{'name': 'erzhen Chen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emergency intensive care unit of Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erzhen Chen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}