The Treatment of Hepatocirrhosis and Portal Hypertension

Study Overview
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Brief Summary
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This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.

Detailed Description
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Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.

Official Title
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Partial Splenic Embolization Combined With Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate in Cirrhosis Patients With Hypersplenism: a Multicenter Randomized Controlled Trial

Conditions
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Hepatic Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Procedure: Endoscopic therapy+ beta blockers
* Procedure: Endoscopic therapy+ PSE+beta blockers
* Procedure: beta blockers
* Procedure: Endoscopic therapy
* Procedure: Endoscopic therapy+ PSE
* Procedure: Somatostatin+Endoscopic therapy
* Procedure: Somatostatin+Endoscopic therapy+PSE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 75 years 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 : Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondary prevention-1<br>Endoscopic therapy+ beta blockers | Procedure: Endoscopic therapy+ beta blockers<br>* 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.<br>|
| Experimental: Secondary prevention-2<br>Endoscopic therapy+ PSE+beta blockers | Procedure: Endoscopic therapy+ PSE+beta blockers<br>* 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.<br>|
| Experimental: Primary prevention-1<br>Beta blockers | Procedure: beta blockers<br>* A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.<br>|
| Experimental: Primary prevention-2<br>Endoscopic therapy | Procedure: Endoscopic therapy<br>* Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).<br>|
| Experimental: Primary prevention-3<br>Endoscopic therapy+ PSE | Procedure: Endoscopic therapy+ PSE<br>* 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.<br>|
| Experimental: Acute bleeding-1<br>Somatostatin+endoscopic therapy | Procedure: Somatostatin+Endoscopic therapy<br>* 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).<br>|
| Experimental: Acute bleeding-2<br>Somatostatin+endoscopic therapy+PSE | Procedure: Somatostatin+Endoscopic therapy+PSE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was variceal rebleeding | The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up | The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up. | 2 years | 
| Changes of the peripheral blood cell counts including white blood cell, red blood cell, and platelate counts in both group during 2-years follow up. | The physiological parameters including white blood cell (*10^9/L), red blood cell (*10^12/L) and platelte(*10^12/L) will compared between the two groups. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker