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

Last updated: October 8, 2019
Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Ulcers

Liver Disease

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT04075760
EUS-PP-GV
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, presenceof portal hypertensive gastropathy)

  • Patient preference for EUS-guided therapy.

Exclusion

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 gallbladderwalls.

  • Esophageal stricture.

  • Uncontrolled coagulopathy.

Study Design

Total Participants: 26
Study Start date:
August 01, 2019
Estimated Completion Date:
October 31, 2020

Study 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.

Connect with a study center

  • Instituto Ecuatoriano de Enfermedades Digestivas

    Guayaquil, Guayas 090505
    Ecuador

    Active - Recruiting

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