Cirrhosis, Gastric Varix, GastroIntestinal Bleeding
Conditions
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 purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
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 or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I. The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial. The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.
Interventions
PROCEDURECoils + Cyanoacrylate Group + beta-blocker
EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group.
DRUGbeta blocker therapy
A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was 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 was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Sponsors
Instituto Ecuatoriano de Enfermedades Digestivas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation
Intervention model description
Randomized control trial, parallel location , 1:1 allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding rate secondary to gastric varices | 12 months | Number of patients with melena or hematemesis accompanied by Hemoglobin drop \> 2g/dL |
| Mortality secondary to gastrointestinal bleeding | 12 months | mortality rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of reinterventions | 12 months | number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices |
Countries
Ecuador
Contacts
Primary ContactCarlos Robles-Medranda, M.D.
Backup ContactRoberto Oleas, M.D.
Outcome results
None listed