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Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

NCT06106971 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-10-30

No results posted yet for this study

Summary

The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. The main questions it aims to answer are:

* Recurrent gastric variceal bleeding
* Further decompensation of liver cirrhosis

Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.

Conditions

  • Gastric Varices Bleeding
  • Liver Decompensation

Interventions

DRUG

Sodium tetradecyl sulfate

Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.

DRUG

Cyanoacrylate

Subjects receive endoscopic cyanoacrylate injection at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding then receive repeated endoscopic cyanoacrylate injection at 1-month intervals until obliteration of gastric varices.

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Wen-Chi Chen, M.D · Kaohsiung Veterans General Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Taiwan

Study Locations

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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 NCT06106971 on ClinicalTrials.gov