Status:

COMPLETED

The Treatment of Hepatocirrhosis and Portal Hypertension

Lead Sponsor:

Yanjing Gao

Collaborating Sponsors:

Shandong Provincial Hospital

Jinan Military General Hospital

Conditions:

Hepatic Cirrhosis

Portal Hypertension

Eligibility:

All Genders

18-75 years

Phase:

NA

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 hypers...

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 ...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    February 1 2016

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2020

    Estimated Enrollment :

    108 Patients enrolled

    Trial Details

    Trial ID

    NCT02778425

    Start Date

    February 1 2016

    End Date

    January 1 2020

    Last Update

    February 14 2025

    Active Locations (1)

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    1

    Department of Gastroenterology,Qilu Hospital,Shandong University

    Jinan, Shandong, China, 250012