The Treatment of Hepatocirrhosis and Portal Hypertension

Yanjing Gao

Status: Completed

Conditions: Hepatic Cirrhosis; Portal Hypertension

Treatments: Procedure: Somatostatin+Endoscopic therapy+PSE; Procedure: Endoscopic therapy+ PSE+beta blockers; Procedure: beta blockers; Procedure: Endoscopic therapy+ beta blockers; Procedure: Somatostatin+Endoscopic therapy; Procedure: Endoscopic therapy; Procedure: Endoscopic therapy+ PSE

Study type: Interventional

Funder types: Other

Identifiers

NCT02778425

201602-QILU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 7 patient groups

Secondary prevention-1

Experimental group

Description:

Endoscopic therapy+ beta blockers

Treatment:

Procedure: Endoscopic therapy+ beta blockers

Secondary prevention-2

Experimental group

Description:

Endoscopic therapy+ PSE+beta blockers

Treatment:

Procedure: Endoscopic therapy+ PSE+beta blockers

Primary prevention-1

Experimental group

Description:

Beta blockers

Treatment:

Procedure: beta blockers

Primary prevention-2

Experimental group

Description:

Endoscopic therapy

Treatment:

Procedure: Endoscopic therapy

Primary prevention-3

Experimental group

Description:

Endoscopic therapy+ PSE

Treatment:

Procedure: Endoscopic therapy+ PSE

Acute bleeding-1

Experimental group

Description:

Somatostatin+endoscopic therapy

Treatment:

Procedure: Somatostatin+Endoscopic therapy

Acute bleeding-2

Experimental group

Description:

Somatostatin+endoscopic therapy+PSE

Treatment:

Procedure: Somatostatin+Endoscopic therapy+PSE