Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT04198259
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019168', 'term': 'Portasystemic Shunt, Transjugular Intrahepatic'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of gastric variceal rebleeding', 'timeFrame': '12 months', 'description': 'Confirmed by endoscopy'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of variceal hemorrhage related death', 'timeFrame': '12 months'}, {'measure': 'Cumulative incidence of hepatic encephalopathy (HE)', 'timeFrame': '12 months', 'description': 'HE is classified as covert HE and overt HE'}, {'measure': 'Cumulative incidence of death', 'timeFrame': '12 months', 'description': 'all cause mortality'}, {'measure': 'Cumulative incidence of adverse events', 'timeFrame': '12 months', 'description': 'number of adverse events and adverse reactions in each arm'}, {'measure': 'Correlation between hepatic venous pressure gradient response and cardiac index response to Carvedilol', 'timeFrame': '12 months', 'description': 'Investigate non-invasive tools for risk stratification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TIPS', 'HVPG', 'BRTO', 'NSBB'], 'conditions': ['Gastric Varices Bleeding', 'Liver Cirrhoses']}, 'descriptionModule': {'briefSummary': 'Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. For the prevention of gastric variceal bleeding, TIPS or BRTO as firstline treatments were suggested.\n\nNo randomized trials have compared BRTO with other therapies. BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome. Therefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.', 'detailedDescription': 'Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. GV are classified according to their location in the stomach and their relationship with esophageal varices (EV). Accordingly, GV are divided into gastroesophageal varices (GOV) and isolated gastric varices (IGV) . The management of type 1 GOV, which extend from the esophagus along the lesser curvature of the stomach, is similar to the management of EV. Historically, bleeding from type 2 GOV (i.e. GOV extending into the fundus), type 1 IGV (i.e. located in the fundus) and type 2 IGV (i.e. located anywhere in the stomach), is considered to be more severe and difficult to treat than EV bleeding. Few studies, mostly retrospective and uncontrolled, have focused on the management of non-GOV1 GV, and the optimal treatment remains controversial.\n\nFor the prevention of gastric variceal bleeding, treatment principles can be classified into two categories: decreasing portal pressure and obstructing GEV. Methods for decreasing portal pressure include medications (NSBB), radiological intervention (TIPS) and surgery. In contrast, methods for treating the obstruction of GEV include endoscopic approaches (EVL, EIS) or radiological intervention (such as BRTO). Recent portal hypertensive bleeding suggested TIPS or BRTO as firstline treatments in the prevention of rebleeding.\n\nBRTO is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral. The technique involves retrograde cannulation of the left renal vein by the jugular or femoral vein, followed by balloon occlusion and slow infusion of sclerosant to obliterate the gastro-/splenorenal collateral and fundal varices. Several variations of the technique exist, such as balloon-occluded antegrade transvenous obliteration or occlusion of the collateral by the placement of a vascular plug or coils. BRTO has the theoretical advantage over TIPS that it does not divert portal blood inflow from the liver. On the other hand, BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome.\n\nTherefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis diagnosed by clinical examination, imaging or biopsy\n* Patients with a previous history of variceal hemorrhage\n* Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2\n* Aged 18 to 75 years\n* Adequate liver and kidney function, including Child-Turcotte-Pugh score \\< 12, MELD score \\<19, and serum creatinine less than 2 times the upper limit of normal.\n\nExclusion Criteria:\n\n* Active variceal bleeding\n* Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices;\n* Refractory ascites\n* Patients with contraindication to treatment of TIPS, including congestive heart failure, NYHA III and IV, pulmonary arterial hypertension(\\>50mmHg), polycystic liver, intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic encephalopathy\n* Patients with contraindication to treatment of Carvedilol, including asthma, insulin-dependent diabetes, peripheral vascular diseases\n* Child-Turcotte-Pugh score \\>=12, or MELD score \\>=19\n* Budd-Chiari syndrome\n* The main portal vein thrombosis is greater than 50%\n* Malignancies\n* An uncontrolled infection\n* Previously treated with TIPS, splenectomy pericardia vascular disconnection, or surgical shunts\n* HIV or HIV related illness\n* Allergic to contrast agent\n* Lactating or pregnant\n* Non-compliant patients'}, 'identificationModule': {'nctId': 'NCT04198259', 'briefTitle': 'Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS for the Prevention of Gastric Variceal Rebleeding in Patients With Liver Cirrhosis: A Prospective, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'KY20192116-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'interventional devascularization', 'description': 'Interventional devascularization includes BRTO and similar procedure. Several variations of the technique exist, such as balloon-occluded antegrade transvenous obliteration or occlusion of the collateral by the placement of a vascular plug or coils.', 'interventionNames': ['Procedure: interventional devascularization']}, {'type': 'EXPERIMENTAL', 'label': 'Transjugular intrahepatic portosystemic shunt', 'description': 'TIPS is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein.', 'interventionNames': ['Procedure: TIPS']}], 'interventions': [{'name': 'interventional devascularization', 'type': 'PROCEDURE', 'description': 'Interventional devascularization (BRTO and its variations) is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral.', 'armGroupLabels': ['interventional devascularization']}, {'name': 'TIPS', 'type': 'PROCEDURE', 'description': 'TIPS is very effective in the treatment of bleeding GV, with more than a 90% success rate for initial hemostasis. It frequently requires additional embolization of spontaneous collaterals feeding the varices. The incidence of encephalopathy was higher after TIPS.', 'armGroupLabels': ['Transjugular intrahepatic portosystemic shunt']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Tie, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'tiejun7776@163.com', 'phone': '+862984771537'}, {'name': 'Hui Chen, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'qychenhui@163.com', 'phone': '+862984771537'}], 'overallOfficials': [{'name': 'Jun Tie, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of clinical research', 'investigatorFullName': 'Tie Jun', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}