The Treatment of Hepatocirrhosis and Portal Hypertension

Not Applicable

Completed

• Conditions: Hepatic Cirrhosis; Portal Hypertension

• Registration Number: NCT02778425
• Lead Sponsor: Yanjing Gao

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Primary Completion: 2019-12
• Study Completion: 2020-01
• Status Verified: 2021-09
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China