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Recruiting NCT06736314

Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus

No phase Interventional Gastric Variceal Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a removable titanium clip.
Who it may be relevant to
Registry conditions: Gastric Variceal Bleeding. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Single-center Exploratory Clinical Study on the Use of Removable Titanium Clips for the Treatment of Acute Variceal Hemorrhage from the Gastric Fundus

Overview

Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus

Detailed description

During the procedure, a removable titanium clip was used to block the bleeding vessels, enabling rapid hemostasis. Five days later, secondary preventive measures such as ECI or TIPS were performed. The titanium clip was removed during or after the procedure, avoiding its retention in the body, which could interfere with subsequent MRI examinations and related treatments. In situations where emergency ECI or other treatments are not feasible, this method can serve as a 'temporary bridge' for the treatment of acute gastric fundal variceal hemorrhage, potentially saving the patient's life.

Interventions

  • Device a removable titanium clip
    The removable titanium clip is a new type of titanium clip that offers advantages such as easy operation and convenient disassembly.

Primary outcome measures

  • Rebleeding rate within 5 days after treatment [Time frame: within 5 days after treatment]

Eligibility criteria

Inclusion criteria

  • The patient and their family agree to and sign the relevant informed consent form.
  • Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
  • History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
  • Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
  • Patients who are hemodynamically stable before or after initial fluid resuscitation.
  • Aged 18 to 75 years.

Exclusion criteria

  • Those with concomitant bleeding from ruptured esophageal varices.
  • A history of gastrointestinal-related surgical procedures.
  • Individuals with altered consciousness who are difficult to treat.
  • Those with concomitant malignant tumors.
  • Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
  • Pregnant and breastfeeding women.
  • Those with contraindications to relevant treatments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Removable Titanium Clip — Nanjing

Identifiers

NCT: NCT06736314 · DZQH-KYLLFS-24-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗