Gastroesophageal Varices, Hypersplenism, Portal Hypertension
Conditions
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.
Interventions
DEVICEcoils
EUS-guided injection of coils
EUS-guided injection of cyanoacrylate glue
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of EUS-guided treatment for varices | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism | 6 months | Safety will be determined by measure of incidence of adverse events related to EUS-guided procedure within and after 30 days of the procedure. |
| Efficacy of EUS-guided partial splenic embolization | 6 months | 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. |
Countries
China
Contacts
Primary ContactQian Chen, Ph.D M.D
Outcome results
None listed