Status:
UNKNOWN
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Lead Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Conditions:
Gastric Varix
Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpos...
Detailed Description
Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring \>2 U of blood...
Eligibility Criteria
Inclusion
- Above 18 years old
- Writeen informed consent provided.
- Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
- Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
- Patient preference for EUS-guided therapy.
Exclusion
- Under 18 years old.
- Refuse to sign written informed consent.
- Pregnancy or nursing.
- Previous treatment of gastric varices.
- Non-cirrhotic portal hypertension
- Concurrent hepato-renal syndrome and/or multi-organ failure.
- Proven malignancy including hepatocellular carcinoma
- Platelet count less than 50,000/ml or International Normalized Rate (INR) \>2.
- Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
- Esophageal stricture.
- Uncontrolled coagulopathy.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04075760
Start Date
August 1 2019
End Date
October 1 2020
Last Update
October 10 2019
Active Locations (1)
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1
Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, Ecuador, 090505