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

Portal Hypertension Clinical Trial

Official title:

EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692805
• Other study ID #: S320
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2021
• Source: Tongji Hospital
• Contact: Qian Chen, Ph.D M.D
• Phone: +86 13697322504
• Email: chenqian201579[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: January 5, 2022
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Varices
• Hypersplenism
• Hypertension
• Hypertension, Portal
• Portal Hypertension
• Varicose Veins

Intervention

Device:
• coils
EUS-guided injection of coils

Drug:
• cyanoacrylate glue
EUS-guided injection of cyanoacrylate glue

Locations

Country	Name	City	State
China	The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of EUS-guided treatment for varices	Efficacy will be determined by recording recurrent events of hematemesis and/or melena after the EUS-guided procedure. Further confirmation of gastroesophageal variceal hemorrhage will be evaluated by upper gastric endoscopy and lab tests.	6 months
Secondary	Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism	Safety will be determined by measure of incidence of adverse events related to EUS-guided procedure within and after 30 days of the procedure.	6 months
Secondary	Efficacy of EUS-guided partial splenic embolization	Efficacy will be measured by rates of successful technique among all performance. Technical success is defined as complete obliteration of the branch of splenic artery and absence of Doppler flow on EUS, and functional success, defined as improved hematologic parameters and the detectable splenic infarction by CT.	6 months