The Treatment of Hepatocirrhosis and Portal Hypertension
NCT ID: NCT02778425
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2016-02-29
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Secondary prevention-1
Endoscopic therapy+ beta blockers
Endoscopic therapy+ beta blockers
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
Secondary prevention-2
Endoscopic therapy+ PSE+beta blockers
Endoscopic therapy+ PSE+beta blockers
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
Primary prevention-1
Beta blockers
beta blockers
A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
Primary prevention-2
Endoscopic therapy
Endoscopic therapy
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Primary prevention-3
Endoscopic therapy+ PSE
Endoscopic therapy+ PSE
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
Acute bleeding-1
Somatostatin+endoscopic therapy
Somatostatin+Endoscopic therapy
The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Acute bleeding-2
Somatostatin+endoscopic therapy+PSE
Somatostatin+Endoscopic therapy+PSE
The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
Interventions
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Endoscopic therapy+ beta blockers
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
Endoscopic therapy+ PSE+beta blockers
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
beta blockers
A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
Endoscopic therapy
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Endoscopic therapy+ PSE
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
Somatostatin+Endoscopic therapy
The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Somatostatin+Endoscopic therapy+PSE
The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
Eligibility Criteria
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Inclusion Criteria
* Patients who had recovered from an episode of VH or patients who had survived from acute VH and there was no bleeding for consecutive 5 days
* Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination
* Patients with hypersplenism and thrombocytopenia (platelets \< 100,000/µL).
Exclusion Criteria
* Bleeding from isolated gastric or ectopic varices
* Hepatocellular carcinoma or other malignant tumors
* Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40%
* Hepatic failure
* Contraindications for PSE
* Pregnancy and lactation
* Inability to sign the informed consent.
18 Years
75 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Jinan Military General Hospital
OTHER
Yanjing Gao
OTHER
Responsible Party
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Yanjing Gao
Vice presidengt of Department of Gastroenterology of Qilu Hospital
Principal Investigators
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Yanjing Gao Yanjing Gao, PhD.MD
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital,Shandong Universty
Locations
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Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, China
Countries
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References
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Wei M, Chen Y, Wang M, Li J, Zeng Y, Sun X, Zhang A, Liu X, Zhou T, Gao Y. Partial splenic embolization combined with endoscopic therapies and vasoconstrictive drugs reduces rebleeding in cirrhosis patients with acute variceal bleeding and hypersplenism: a multicenter randomized controlled trial. J Gastroenterol. 2023 Nov;58(11):1144-1153. doi: 10.1007/s00535-023-02027-1. Epub 2023 Jul 24.
Sun X, Zhang A, Zhou T, Wang M, Chen Y, Zhou T, Chen X, Xiu A, Peng Z, Cheng B, Liu X, Gao Y. Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial. Hepatol Int. 2021 Jun;15(3):741-752. doi: 10.1007/s12072-021-10155-0. Epub 2021 Feb 27.
Other Identifiers
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201602-QILU
Identifier Type: -
Identifier Source: org_study_id
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