Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT01321060
Status:
UNKNOWN
Last Update Posted:
2012-06-19
First Post:
2011-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Collections Management in Severe 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': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2012-06-16', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pancreatic infection', 'timeFrame': '28 days'}, {'measure': 'mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'inflammation parameters', 'timeFrame': '28 days'}, {'measure': 'intra abdominal pressure', 'timeFrame': '28 days'}, {'measure': 'complications', 'timeFrame': '28 days', 'description': 'intestinal fistula , major bleeding, etc.'}, {'measure': 'ICU duration', 'timeFrame': 'day one until discharge'}, {'measure': 'hospital duration', 'timeFrame': 'day one until discharge'}, {'measure': 'SIRS', 'timeFrame': '28 days'}, {'measure': 'MODS', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe acute pancreatitis', 'acute fluid collection', 'catheter drainage', 'repeated aspiration'], 'conditions': ['Acute Pancreatitis', 'Acute Pancreatic Fluid Collection']}, 'descriptionModule': {'briefSummary': 'Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination\n* CT density \\< 30Hu\n* Within 7 days from the onset of the disease\n* Available approach for percutaneous penetrate\n\nExclusion Criteria:\n\n* Pregnant pancreatitis\n* Receiving surgery or aspiration before;need of early surgery\n* Infected fluid collection'}, 'identificationModule': {'nctId': 'NCT01321060', 'acronym': 'FCMSAP', 'briefTitle': 'Fluid Collections Management in Severe Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RIGS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'Conservative treatment group with only drugs.', 'interventionNames': ['Drug: Conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous catheter drainage', 'description': 'Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.', 'interventionNames': ['Procedure: Catheter drainage']}, {'type': 'EXPERIMENTAL', 'label': 'Repeated aspiration', 'description': 'Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.', 'interventionNames': ['Procedure: Aspiration']}], 'interventions': [{'name': 'Aspiration', 'type': 'PROCEDURE', 'armGroupLabels': ['Repeated aspiration']}, {'name': 'Catheter drainage', 'type': 'PROCEDURE', 'armGroupLabels': ['Continuous catheter drainage']}, {'name': 'Conservative treatment', 'type': 'DRUG', 'description': 'Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation', 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqin Li, Dr', 'role': 'CONTACT', 'email': 'kkb9832@gmail.com', 'phone': '+86-025-80860066'}, {'name': 'Weiqin Li, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of SICU, Research Institute of General Surgery Jinling Hospital,', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Weiqin Li, Dr', 'role': 'CONTACT', 'email': 'kkb9832@gmail.com', 'phone': '+86-025-80860066'}, {'name': 'Zhihui Tong, Dr', 'role': 'CONTACT', 'email': 'njzyantol@hotmail.com', 'phone': '+86-025-80860066'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinling Hospital, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of surgical ICU', 'investigatorFullName': 'Weiqin Li', 'investigatorAffiliation': 'Nanjing University School of Medicine'}}}}