About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
< 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.
Trial design
Single group
Treatments tested in this trial
Detachable Clip
Other interventionAfter the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed
Treatment groups
Trial outcomes
Primary outcomes
Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yu Chang
Lead sponsor
Nanjing University of Traditional Chinese Medicine
Sponsor institution