EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2022
CompletedJanuary 8, 2021
January 1, 2021
6 months
December 29, 2020
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism
6 months
Efficacy of EUS-guided partial splenic embolization
6 months
Study Arms (2)
EUS-guided treatment of varices
EXPERIMENTALProcedure: 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).
EUS-guided partial splenic embolization + EUS-guided treatment of varices
EXPERIMENTALProcedure: 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).
Interventions
EUS-guided injection of coils
EUS-guided injection of cyanoacrylate glue
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qian Chen, Ph.D, M.D
Tongji Hospital
- STUDY CHAIR
Zhen-gang Zhang, Ph.D, M.D
Tongji Hospital
- STUDY CHAIR
Bin Cheng, Ph.D, M.D
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2020
First Posted
January 5, 2021
Study Start
January 5, 2021
Primary Completion
July 5, 2021
Study Completion
January 5, 2022
Last Updated
January 8, 2021
Record last verified: 2021-01