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

Shandong University

Status: Unknown

Conditions: Hypersplenism; Liver Cirrhosis; Esophageal and Gastric Varices

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05055713

20200925-Qilu

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 368 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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368 participants in 6 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:

Endoscopic therapy

Treatment:

Procedure: Endoscopic therapy

Primary prevention-2

Experimental group

Description:

Endoscopic therapy+ PSE

Treatment:

Procedure: Endoscopic therapy+ PSE

Acute bleeding-1

Experimental group

Description:

Endoscopic therapy+somatostatin

Treatment:

Procedure: Endoscopic therapy+Somatostatin

Acute bleeding-2

Experimental group

Description:

Endoscopic therapy+PSE+somatostatin

Treatment:

Procedure: Endoscopic therapy+PSE+Somatostatin