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Clinical Trials/JPRN-jRCT1032200110
JPRN-jRCT1032200110
Recruiting
Phase 2

Safety and efficacy of endoscopic ultrasonography-guided balloon-occluded sclerotherapy

Kato Naoya0 sites6 target enrollmentSeptember 9, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Kato Naoya
Enrollment
6
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 9, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kato Naoya

Eligibility Criteria

Inclusion Criteria

  • 1\) Patients with esophageal varices
  • 2\) Child\-Pugh score A or B
  • 3\) Age 20 years or older (any gender)
  • 4\) Patients who have been fully informed about the study and have given their voluntary written consent to participate in the study.

Exclusion Criteria

  • 1\) Renal dysfunction with an eGFR of less than 30 (excluding dialysis patients).
  • 2\) The patient who has one of the following cardiac diseases
  • a) Heart failure of NYHA class 3 or higher.
  • b) Current symptomatic coronary artery disease or a history of myocardial infarction within 4 weeks prior to enrollment.
  • 3\) Serious and active infection (CTCAE version 4\.0 Grade 3 or higher)
  • 4\) Pregnant women, lactating women, and women who may or will become pregnant (if pregnancy is suspected, a pregnancy test should be performed).
  • 5\) Other risks that may jeopardize patient safety or make it difficult to comply with the study protocol.

Outcomes

Primary Outcomes

Not specified

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