Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 31, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedNovember 1, 2024
October 1, 2024
1 year
October 31, 2024
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis
6 weeks
Study Arms (1)
Detachable Clip-assisted
EXPERIMENTALAfter the varicose vessel is closed with a removable titanium clamp, the more varicose target vessel is located，After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed
Interventions
After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \< 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yu Changlead
Study Sites (1)
Eastern Theater General Hospital
Nanjing, Jiangsu, 210000, China
Study Officials
- PRINCIPAL INVESTIGATOR
ji xuan, doctor
Eastern Theater General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- student
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 1, 2024
Study Start
May 1, 2024
Primary Completion
May 1, 2025
Study Completion
October 30, 2025
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR