The Treatment of Hepatocirrhosis and Portal Hypertension

September 8, 2021 updated by: Yanjing Gao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology,QiLu Hospital,Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secondary prevention-1
Endoscopic therapy+ beta blockers
Procedure: Endoscopic therapy+ beta blockers
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.
Experimental: Secondary prevention-2
Endoscopic therapy+ PSE+beta blockers
Procedure: Endoscopic therapy+ PSE+beta blockers
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.
Experimental: Primary prevention-1
Beta blockers
Procedure: beta blockers
A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
Experimental: Primary prevention-2
Endoscopic therapy
Procedure: Endoscopic therapy
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Experimental: Primary prevention-3
Endoscopic therapy+ PSE
Procedure: Endoscopic therapy+ PSE
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.
Experimental: Acute bleeding-1
Somatostatin+endoscopic therapy
Procedure: Somatostatin+Endoscopic therapy
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).
Experimental: Acute bleeding-2
Somatostatin+endoscopic therapy+PSE
Procedure: Somatostatin+Endoscopic therapy+PSE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanjing Gao

Collaborators

Shandong Provincial Hospital
Jinan Military General Hospital

Investigators

  • Principal Investigator: Yanjing Gao Yanjing Gao, PhD.MD, Qilu Hospital,Shandong Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201602-QILU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All the individual participant data (IPD) available to other researchers.

IPD Sharing Time Frame

2021.1

IPD Sharing Access Criteria

Open Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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