Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT07053605
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The immune function at 7 days after surgery', 'timeFrame': '7 days', 'description': 'The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 7 days after surgery.'}, {'measure': 'The immune function at 1 month after surgery', 'timeFrame': '1 month', 'description': 'The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 1 month after surgery.'}, {'measure': 'The immune function at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 3 months after surgery.'}, {'measure': 'The immune function at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 6 months after surgery.'}, {'measure': 'The immune function at 12months after surgery', 'timeFrame': '12months', 'description': 'The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 12months after surgery.'}, {'measure': 'Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 1 month postoperatively.', 'timeFrame': '1 month', 'description': '1 month'}, {'measure': 'Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 3 months postoperatively.', 'timeFrame': '3 months', 'description': '3 months'}, {'measure': 'Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 6 months postoperatively.', 'timeFrame': '6 months', 'description': '6 months'}, {'measure': 'Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 12 months postoperatively.', 'timeFrame': '12 months', 'description': '12 months'}, {'measure': 'Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 1 month postoperatively.', 'timeFrame': '1 month', 'description': '1 month'}, {'measure': 'Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 3 months postoperatively.', 'timeFrame': '3 months', 'description': '3 months'}, {'measure': 'Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 6 months postoperatively.', 'timeFrame': '6 months', 'description': '6 months'}, {'measure': 'Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 12 months postoperatively.', 'timeFrame': '12 months', 'description': '12 months'}, {'measure': 'Thrombosis in the Portal Venous System.', 'timeFrame': '1 month', 'description': '1 month'}, {'measure': 'Thrombosis in the Portal Venous System.', 'timeFrame': '3 months', 'description': '3 months'}, {'measure': 'Thrombosis in the Portal Venous System.', 'timeFrame': '6 months', 'description': '6 months'}, {'measure': 'Thrombosis in the Portal Venous System.', 'timeFrame': '12 months', 'description': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'resection of splenic artery aneurysm', 'Immune function', 'Hemodynamics'], 'conditions': ['Splenic Artery Aneurysm', 'Immune Function', 'Hemodynamics']}, 'descriptionModule': {'briefSummary': 'In this study, researchers examined the changes in related indicators such as immune function, splenic vein,proper hepatic artery, and portal venous hemodynamics following laparoscopic resection of a splenic artery aneurysm. We determined the changes in these patient-related indicators after surgical treatment and whether these changes could improve patient outcomes.', 'detailedDescription': 'Patients with Splenic Artery Aneurysm were recruited in accordance with the research inclusion criteria, and their general demographic information was collected. After thorough preoperative preparation, the same surgical team performed laparoscopic resection of the splenic artery aneurysm. Postoperatively,the same nursing team provided standardized care. Subsequently, patients received a standardized postoperative treatment protocol, which included pharmacotherapy, additional therapeutic interventions, and follow-up visits. During the treatment period, routine blood tests,liver function tests, coagulation function,immune function, as well as the hemodynamics of the portal vein, proper hepatic artery, and splenic vein were monitored preoperatively and at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic splenic artery aneurysms with a diameter\\>2 cm,ruptured splenic artery aneurysms,and splenic artery aneurysms with a diameter increase\\>0.5 cm/year.\n\nAneurysm located in the main trunk of the splenic artery. Informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with malignancies Hepatic cirrhosis with portal hypertension peptic ulcer disease Recent peptic ulcer disease History of Hemorrhagic stroke Pregnancy hematological diseases Uncontrolled Hypertension Human immunodeficiency virus (HIV) infection'}, 'identificationModule': {'nctId': 'NCT07053605', 'briefTitle': 'Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen', 'orgStudyIdInfo': {'id': 'YZUC-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The laparoscopic resection of splenic artery aneurysm is performed by the same surgical team.', 'description': 'The laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team.', 'interventionNames': ['Procedure: laparoscopic resection of splenic artery aneurysm with preservation of spleen']}], 'interventions': [{'name': 'laparoscopic resection of splenic artery aneurysm with preservation of spleen', 'type': 'PROCEDURE', 'description': 'The laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team.', 'armGroupLabels': ['The laparoscopic resection of splenic artery aneurysm is performed by the same surgical team.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'China', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Qing Jiang', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}, {'name': 'Guo-Qing Jiang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tian-Ming Gao', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hao Dong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Medical College, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Guo-Qing Jiang', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}, {'name': 'Dou-Sheng Bai', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}], 'overallOfficials': [{'name': 'Guo-Qing Jiang', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Medical College, Yangzhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Guo-Qing Jiang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}