EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Gastric Varix, Cirrhosis, GastroIntestinal Bleeding
About this trial
This is an interventional prevention trial for Gastric Varix
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Instituto Ecuatoriano de Enfermedades DigestivasRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
EUS-guided combined therapy
Beta Blocker (Propranolol)
Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.
o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.