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Clinical Trials/NCT06670157
NCT06670157
Recruiting
Not Applicable

Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices Under X-ray Perspective

Yu Chang1 site in 1 country6 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Varices Bleeding
Sponsor
Yu Chang
Enrollment
6
Locations
1
Primary Endpoint
Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

A single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
October 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Yu Chang
Responsible Party
Sponsor Investigator
Principal Investigator

Yu Chang

student

Nanjing University of Traditional Chinese Medicine

Eligibility Criteria

Inclusion Criteria

  • The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more.

Exclusion Criteria

  • \< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.

Outcomes

Primary Outcomes

Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis

Time Frame: 6 weeks

Study Sites (1)

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