Clinical trial NCT04075760: EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Official title: EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varix
Cirrhosis
GastroIntestinal Bleeding
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial, parallel location , 1:1 allocation
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Bleeding rate secondary to gastric varices
timeFrame: 12 months
measure: Mortality secondary to gastrointestinal bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Number of reinterventions
timeFrame: 12 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano de Enfermedades Digestivas
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas
name: Carlos Robles-Medranda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.