Hepatic Cirrhosis, Portal Hypertension
Conditions
Keywords
Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker, hepatic recompensation
Brief summary
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
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.
Interventions
PROCEDUREEndoscopic 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 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.
PROCEDUREbeta 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.
PROCEDUREEndoscopic therapy
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
PROCEDUREEndoscopic 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.
PROCEDURESomatostatin+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).
PROCEDURESomatostatin+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.
Sponsors
Shandong Provincial Hospital
Jinan Military General Hospital
Yanjing Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint was variceal rebleeding | 2 years | The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up. |
| The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up. | 2 years | The hepatic recompensation rate based on Baveno VII criteria in the EP group will compared to that in the E group during the follow-up. Hepatic recompensation is a comprehensive assessment index defined as meeting all of the following criteria simultaneously: (1)Etiological Control: Removal/suppression/cure of the primary cause of cirrhosis (e.g., hepatitis C virus elimination, sustained suppression of hepatitis B virus, and sustained abstinence from alcohol in alcoholic cirrhosis); (2)Symptomatic Resolution: Regression of ascites (discontinuation of diuretics), remission of hepatic encephalopathy (discontinuation of lactulose/rifaximin), and absence of recurrent variceal bleeding (for at least 12 months); (3)Improvement in Liver Function: Stable improvement in liver function tests (albumin, INR, bilirubin). Assessed via lab tests (HCV RNA, HBV DNA, albumin, INR, bilirubin) and clinical evaluation (ascites, encephalopathy, endoscopy). Reported as binary (Yes/No). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up | 2 years | The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up. |
| 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. | 2 years | 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. |
| The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up. | 2 years | Changes in liver function (Child-Pugh score, MELD score) and physiological parameters (white blood cell count \[\*10\^9/L\], red blood cell count \[\*10\^12/L\], platelet count \[\*10\^12/L\], hemoglobin \[g/dL\], and coagulation parameters) will be assessed and compared during the 1-year follow-up between the two groups. |
Countries
China
Outcome results
None listed