Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:30 PM
Study NCT ID:
NCT07490405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008238', 'term': 'Lysergic Acid Diethylamide'}, {'id': 'D019168', 'term': 'Portasystemic Shunt, Transjugular Intrahepatic'}], 'ancestors': [{'id': 'D008237', 'term': 'Lysergic Acid'}, {'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011170', 'term': 'Portasystemic Shunt, Surgical'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2036-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival rate', 'timeFrame': '5-year', 'description': 'overall survival rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Cirrhosis', 'LSD', 'TIPS'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This study aims to compare two treatments for cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism: laparoscopic splenectomy and azygoportal disconnection (LSD) and transjugular intrahepatic portosystemic shunt (TIPS). It is a single-center, prospective, randomized controlled, superiority trial. The primary outcome is the incidence of post-procedure hepatic encephalopathy. Secondary outcomes include changes in hepatic venous pressure gradient, portal and hepatic artery hemodynamics, liver function, renal function, complete blood count, immune function, hepatic reserve capacity, serological markers of liver fibrosis, re-bleeding rate, hepatocellular carcinoma incidence, overall survival, and bleeding-free survival. The study will provide high-level evidence for optimal treatment selection in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of cirrhotic portal hypertension.\n2. Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment..\n3. Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia.\n4. Liver function Child-Pugh class A or B (score 7-9).\n5. Age 18-75 years.\n6. Patient provides written informed consent.\n\nExclusion Criteria:\n\n1. Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score \\>18.\n2. Severe right heart failure or pulmonary hypertension.\n3. Uncontrolled systemic infection or sepsis.\n4. Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation).\n5. Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies.\n6. Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.\n7. Severe contrast agent allergy (affecting TIPS procedure).\n8. Pregnancy or lactation.\n9. Any severe non-hepatic disease with a life expectancy \\<1 year.\n10. Recent gastric and duodenal ulcers.\n11. Inability to comply with follow-up or provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07490405', 'acronym': 'LSD、TIPS', 'briefTitle': 'Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'Long-term Efficacy and Safety of Laparoscopic Splenectomy and Azygoportal Disconnection Versus Transjugular Intrahepatic Portosystemic Shunt for Cirrhotic Portal Hypertension With Acute Esophagogastric Variceal Bleeding and Hypersplenism', 'orgStudyIdInfo': {'id': 'YZUC-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LSD', 'interventionNames': ['Procedure: LSD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIPS', 'interventionNames': ['Procedure: TIPS']}], 'interventions': [{'name': 'LSD', 'type': 'PROCEDURE', 'description': 'laparoscopic splenectomy and azygoportal disconnection', 'armGroupLabels': ['LSD']}, {'name': 'TIPS', 'type': 'PROCEDURE', 'description': 'Transjugular Intrahepatic Portosystemic Shunt', 'armGroupLabels': ['TIPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225000', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Guoqing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '18051060606'}], 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Guoqing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '18051060606'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Guo-Qing Jiang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}