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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2022-01-05

Brief Summary

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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 portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

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Detailed Description

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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 performed by clinicians engaged in interventional radiology via a transcatheter embolization method as the successful embolization of the selected splenic arteries results in devascularization of a focal lesion followed by splenic infarction and subsequently reducing the splenic contribution to the portal blood flow. Our previous case study suggests implanting coil in a branch of splenic artery under the endoscopic ultrasound (EUS) -guidance followed by the glue injection was an alternative PSE procedure to control hypersplenism. Recent advance has also heightened the therapeutic aspect of EUS in managing varices. We have established the novel approach to manage varices and hypersplenism at the same time by combining EUS-guided PSE and EUS-guided treatment of varices. 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 portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

Conditions

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Gastroesophageal Varices Hypersplenism Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EUS-guided treatment of varices

Procedure: EUS-guided injection of coils with cyanoacrylate glue (CYA) and sclerosing agent.

First CT scan will be ordered to determine the patient having esophageal and gastric varices and splenomegaly.

Complete blood count (CBC) will be ordered to confirm the deficiency of one or more blood cell lines.

A standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient considered as a candidate will be treated with Coils plus CYA and sclerosing agent (Group A).

Group Type EXPERIMENTAL

coils

Intervention Type DEVICE

EUS-guided injection of coils

cyanoacrylate glue

Intervention Type DRUG

EUS-guided injection of cyanoacrylate glue

EUS-guided partial splenic embolization + EUS-guided treatment of varices

Procedure: EUS-guided partial splenic embolization + EUS-guided treatment of varices First CT scan will be ordered to determine the patient having esophageal and gastric varices and splenomegaly.

Complete blood count (CBC) will be ordered to confirm the deficiency of one or more blood cell lines.

A standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient considered as a candidate will be treated with coils plus CYA and sclerosing agent.

At the same procedure, a branch of splenic artery will be identified by EUS and implanted with coils plus CYA (Group B).

Group Type EXPERIMENTAL

coils

Intervention Type DEVICE

EUS-guided injection of coils

cyanoacrylate glue

Intervention Type DRUG

EUS-guided injection of cyanoacrylate glue

Interventions

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coils

EUS-guided injection of coils

Intervention Type DEVICE

cyanoacrylate glue

EUS-guided injection of cyanoacrylate glue

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No