The Treatment of Hepatocirrhosis and Portal Hypertension

Sponsor

Yanjing Gao (Other)

Overall Status

Completed

CT.gov ID

NCT02778425

Collaborator

Shandong Provincial Hospital (Other), Jinan Military General Hospital (Other)

108

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Cirrhosis Portal Hypertension	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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Secondary prevention-1 Endoscopic therapy+ beta blockers	Procedure: 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.
Experimental: Secondary prevention-2 Endoscopic therapy+ PSE+beta blockers	Procedure: 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.
Experimental: Primary prevention-1 Beta blockers	Procedure: 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.
Experimental: Primary prevention-2 Endoscopic therapy	Procedure: Endoscopic therapy Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Experimental: Primary prevention-3 Endoscopic therapy+ PSE	Procedure: 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.
Experimental: Acute bleeding-1 Somatostatin+endoscopic therapy	Procedure: 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).
Experimental: Acute bleeding-2 Somatostatin+endoscopic therapy+PSE	Procedure: 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.

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.