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

Tongji Hospital

Status: Unknown

Conditions: Portal Hypertension; Hypersplenism; Gastroesophageal Varices

Treatments: Drug: cyanoacrylate glue; Device: coils

Study type: Interventional

Funder types: Other

Identifiers

NCT04692805

S320

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

EUS-guided treatment of varices

Experimental group

Description:

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).

Treatment:

Drug: cyanoacrylate glue

Device: coils

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

Experimental group

Description:

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).

Treatment:

Drug: cyanoacrylate glue

Device: coils