Status:

UNKNOWN

EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension

Lead Sponsor:

Tongji Hospital

Conditions:

Gastroesophageal Varices

Hypersplenism

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with port...

Detailed Description

Partial splenic embolization (PSE) was developed in the purpose of managing two common complications of portal hypertension including variceal bleeding and hypersplenism. The procedure is normally per...

Eligibility Criteria

Inclusion

  • At the risk of gastroesophageal variceal hemorrhage; Acute gastroesophageal variceal hemorrhage; Hematemesis and/or melena resulted from gastroesophageal variceal hemorrhage of liver cirrhosis in the past.
  • Hypersplenism is indicated by either abdominal ultrasound or CT image showing splenic enlargement or splenomegaly and CBC test showing deficiency of one or more blood cell lines.
  • Consent form must be signed by patients or their guardians before entering the test.

Exclusion

  • History of liver surgery or spleen surgery and liver cancer
  • Coagulopathy (INR \> 1.5) or having been taken oral anticoagulation agents such as aspirin, warfarin, etc. in the past week.
  • Existence of gastrointestinal endoscopic therapy contraindication; Hemorrhagic shock has not be corrected; Hepatic encephalopathy; Moderate to severe ascites, Poor liver function (Child - Pugh class C).
  • Severe cardiorespiratory dysfunction, including sinus bradycardia, bronchial asthma, chronic obstructive pulmonary disease, heart failure, and atrioventricular block
  • Pregnant women and nursing mothers.
  • Absence of informed consent

Key Trial Info

Start Date :

January 5 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 5 2022

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT04692805

Start Date

January 5 2021

End Date

January 5 2022

Last Update

January 8 2021

Active Locations (1)

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1

The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030