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

Not Applicable

• Conditions: Esophageal and Gastric Varices; Hypersplenism; Liver Cirrhosis
• Interventions: Procedure: Endoscopic therapy; Procedure: Endoscopic therapy+ beta blockers; Procedure: Endoscopic therapy+PSE+Somatostatin; Procedure: Endoscopic therapy+ PSE+beta blockers; Procedure: Endoscopic therapy+ PSE; Procedure: Endoscopic therapy+Somatostatin

• Registration Number: NCT05055713
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-09-25
• Status Verified: 2021-09
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-24
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 368

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary prevention-1	Endoscopic therapy	Endoscopic therapy
Secondary prevention-1	Endoscopic therapy+ beta blockers	Endoscopic therapy+ beta blockers
Acute bleeding-2	Endoscopic therapy+PSE+Somatostatin	Endoscopic therapy+PSE+somatostatin
Secondary prevention-2	Endoscopic therapy+ PSE+beta blockers	Endoscopic therapy+ PSE+beta blockers
Primary prevention-2	Endoscopic therapy+ PSE	Endoscopic therapy+ PSE
Acute bleeding-1	Endoscopic therapy+Somatostatin	Endoscopic therapy+somatostatin

Primary Outcome Measures

Name	Time	Method
rebleeding	2 to 30days	the rate of rebleeding after endoscopic therapy

Trial Locations

Locations (1)

Qilu Hospital , Shandong University; 🇨🇳 Jinan, Shandong, China