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EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I

I

Instituto Ecuatoriano de Enfermedades Digestivas

Status

Unknown

Conditions

GastroIntestinal Bleeding
Cirrhosis
Gastric Varix

Treatments

Drug: beta blocker therapy
Procedure: Coils + Cyanoacrylate Group + beta-blocker

Study type

Interventional

Funder types

Other

Identifiers

NCT04075760
EUS-PP-GV

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

26 participants in 2 patient groups, including a placebo group

EUS-guided combined therapy
Experimental group
Description:
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.
Treatment:
Procedure: Coils + Cyanoacrylate Group + beta-blocker
Beta Blocker (Propranolol)
Placebo Comparator group
Description:
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.
Treatment:
Drug: beta blocker therapy

Trial contacts and locations

1

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Central trial contact

Roberto Oleas, M.D.; Carlos Robles-Medranda, M.D.

Data sourced from clinicaltrials.gov

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