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Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS

NCT04198259 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2020-02-05

No results posted yet for this study

Summary

Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. For the prevention of gastric variceal bleeding, TIPS or BRTO as firstline treatments were suggested.

No randomized trials have compared BRTO with other therapies. BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome. Therefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.

Conditions

  • Gastric Varices Bleeding
  • Liver Cirrhoses

Interventions

PROCEDURE

interventional devascularization

Interventional devascularization (BRTO and its variations) is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral.

PROCEDURE

TIPS

TIPS is very effective in the treatment of bleeding GV, with more than a 90% success rate for initial hemostasis. It frequently requires additional embolization of spontaneous collaterals feeding the varices. The incidence of encephalopathy was higher after TIPS.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Jun Tie, M.D.,Ph.D. · Air Force Military Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198259 on ClinicalTrials.gov