Clinical trial NCT04692805: EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
Official title: EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Varices
Hypersplenism
Portal Hypertension
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of EUS-guided treatment for varices
timeFrame: 6 months
Secondary outcomes:
measure: Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism
timeFrame: 6 months
measure: Efficacy of EUS-guided partial splenic embolization
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qian Chen, Ph.D, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Zhen-gang Zhang, Ph.D, M.D
role: STUDY_CHAIR
affiliation: Tongji Hospital
name: Bin Cheng, Ph.D, M.D
role: STUDY_CHAIR
References: