A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism

Study Overview
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Brief Summary
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The purpose of this study was to compare the effects of partial splenic artery embolization combined with endoscopic treatment and endoscopic treatment alone on portal hypertension in cirrhosis with hyperplenism or splenomegaly in esophageal and gastric varices.

Detailed Description
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Although there have been many consensus opinions on the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage, there is no standard to follow for the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage combined with hypersplenism or splenomegalism, and studies show that the patients with cirrhosis combined with severe hypersplenism account for about 33%. It has been reported that partial splenic artery embolization is effective in the treatment of hypersplenism or splenomegaly caused by portal hypertension in liver cirrhosis, but for liver cirrhosis with esophageal and gastric varices hemorrhage in port or spleen large combined at the same time of endoscopic treatment should joint partial splenic artery embolization treatment remains controversial.Therefore, it is urgent to further study the effect of partial splenic artery embolization combined with endoscopic therapy on cirrhosis with esophageal and gastric variceal hemorrhage combined with hyperspleenism or splenomegaly.

Official Title
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The Effects of Endoscopy Combined With Partial Splenic Artery Embolization in the Treatment of Cirrhosis With Esophageal and Gastric Varices Complicated With Hyperplenism or Splenomegaly:A Randomized Controlled Study.

Conditions
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Liver Cirrhosis, Esophageal and Gastric Varices, Hypersplenism

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


Participation Criteria
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Eligibility Criteria
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Secondary prevention: 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. Primary prevention: Inclusion Criteria: Patients aged between 18 and 75 years Moderate to severe esophageal (and/or) gastric varices 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. Acute bleeding: Inclusion Criteria: Patients aged between 18 and 75 years Acute esophageal (and/or) gastric varices rupture and bleed <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: Single Group Assignment
Masking: None (Open Label)


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 (carvedilol) 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 (carvedilol) 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>Endoscopic therapy | Procedure: Endoscopic therapy<br>* Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).<br>|
| Experimental: Primary prevention-2<br>Endoscopic therapy+ PSE | Procedure: Endoscopic therapy+ PSE<br>* Endoscopic variceal ligation (EVL) is for the secondary 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>Endoscopic therapy+somatostatin | Procedure: Endoscopic therapy+Somatostatin<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>Endoscopic therapy+PSE+somatostatin | Procedure: Endoscopic therapy+PSE+Somatostatin<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 |
| --- | --- | --- |
| rebleeding | the rate of rebleeding after endoscopic therapy | 2 to 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal and Gastric Varices, Hypersplenism, Rebleeding, Partial splenic artery embolization, Endoscopic Variceal Ligation