Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05338294
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The immune function CD4+ at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function CD4+ at 3 months after surgery'}, {'measure': 'The immune function CD4+ at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function CD4+ at 6 months after surgery'}, {'measure': 'The immune function CD4+ at 12 months after surgery', 'timeFrame': '12 months', 'description': 'The level of the immune function CD4+ at 12 months after surgery'}, {'measure': 'The immune function CD4+ at 24 months after surgery', 'timeFrame': '24 months', 'description': 'The level of the immune function CD4+ at 24 months after surgery'}, {'measure': 'The immune function CD8+ at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function CD8+ at 3 months after surgery'}, {'measure': 'The immune function CD8+ at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function CD8+ at 6 months after surgery'}, {'measure': 'The immune function CD8+ at 12 months after surgery', 'timeFrame': '12 months', 'description': 'The level of the immune function CD8+ at 12 months after surgery'}, {'measure': 'The immune function CD8+ at 24 months after surgery', 'timeFrame': '24 months', 'description': 'The level of the immune function CD8+ at 24 months after surgery'}, {'measure': 'The immune function CD4+/CD8+ at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function CD4+/CD8+ at 3 months after surgery'}, {'measure': 'The immune function CD4+/CD8+ at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function CD4+/CD8+ at 6 months after surgery'}, {'measure': 'The immune function CD4+/CD8+ at 12 months after surgery', 'timeFrame': '12 months', 'description': 'The level of the immune function CD4+/CD8+ at 12 months after surgery'}, {'measure': 'The immune function CD4+/CD8+ at 24 months after surgery', 'timeFrame': '24 months', 'description': 'The level of the immune function CD4+/CD8+ at 24 months after surgery'}, {'measure': 'The immune function CD19 at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function CD19 at 3 months after surgery'}, {'measure': 'The immune function CD19 at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function CD19 at 6 months after surgery'}, {'measure': 'The immune function CD19 at 12 months after surgery', 'timeFrame': '12 months', 'description': 'The level of the immune function CD19 at 12 months after surgery'}, {'measure': 'The immune function CD19 at 24 months after surgery', 'timeFrame': '24 months', 'description': 'The level of the immune function CD19 at 24 months after surgery'}, {'measure': 'The immune function CD20 at 3 months after surgery', 'timeFrame': '3 months', 'description': 'The level of the immune function CD20 at 3 months after surgery'}, {'measure': 'The immune function CD20 at 6 months after surgery', 'timeFrame': '6 months', 'description': 'The level of the immune function CD20 at 6 months after surgery'}, {'measure': 'The immune function CD20 at 12 months after surgery', 'timeFrame': '12 months', 'description': 'The level of the immune function CD20 at 12 months after surgery'}, {'measure': 'The immune function CD20 at 24 months after surgery', 'timeFrame': '24 months', 'description': 'The level of the immune function CD20 at 24 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cirrhosis', 'Splenectomy', 'Laparoscopy', 'Immune function', 'Azygoportal disconnection'], 'conditions': ['Cirrhosis, Liver', 'Splenectomy; Status']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators compared the improvement of immune function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.', 'detailedDescription': 'The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy and azygoportal disconnection, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+,CD8+,CD4+/CD8+, and CD19,CD20.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology\n* Splenomegaly with secondary hypersplenism\n* gastroesophageal variceal bleeding\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma or any other malignancy,\n* Child-Pugh grade C\n* Recent peptic ulcer disease\n* History of Hemorrhagic stroke\n* Pregnancy.\n* Uncontrolled Hypertension\n* Human immunodeficiency virus (HIV) infection'}, 'identificationModule': {'nctId': 'NCT05338294', 'acronym': 'ELSDI', 'briefTitle': 'The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients', 'orgStudyIdInfo': {'id': 'YZUC-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic splenectomy and azygoportal disconnection', 'description': 'Laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.', 'interventionNames': ['Procedure: Laparoscopic splenectomy and azygoportal disconnection']}], 'interventions': [{'name': 'Laparoscopic splenectomy and azygoportal disconnection', 'type': 'PROCEDURE', 'description': 'Laparoscopic splenectomy and azygoportal disconnection is performed by the same surgical team.', 'armGroupLabels': ['Laparoscopic splenectomy and azygoportal disconnection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '86-514-87373372'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'bdsno1@hotmail.com', 'phone': '86-514-87373372'}, {'name': 'Guo-Qing Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tian-Ming Gao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Medical College, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}], 'overallOfficials': [{'name': 'Guo-Qing Jiang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Medical College, Yangzhou University'}]}, '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"}}}}