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NCT Number: NCT02778425

The Treatment of Hepatocirrhosis and Portal Hypertension

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.

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Key information

Conditions

Hepatic Cirrhosis Blood Platelet Disorders Cytopenia Digestive System Diseases Fibrosis Hematologic Diseases Hemic and Lymphatic Diseases Hypersplenism Hypertension, Portal Liver Cirrhosis Liver Diseases Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Splenic Diseases Thrombocytopenia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic therapy+ beta blockers

Procedure

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.

Endoscopic therapy+ PSE+beta blockers

Procedure

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.

beta blockers

Procedure

A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.

Endoscopic therapy

Procedure

Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).

Endoscopic therapy+ PSE

Procedure

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.

Somatostatin+Endoscopic therapy

Procedure

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).

Somatostatin+Endoscopic therapy+PSE

Procedure

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.

Primary outcomes

  1. The primary endpoint was variceal rebleeding

    Time frame: 2 years

    The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.

  2. The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.

    Time frame: 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 outcomes

  1. The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up

    Time frame: 2 years

    The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up.

  2. 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.

    Time frame: 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.

  3. The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yanjing Gao

Other

Collaborators

  • Jinan Military General Hospital
  • Shandong Provincial Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 19, 2016
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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