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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06736314
Enrollment
10
Registered
2024-12-16
Start date
2024-12-20
Completion date
2027-11-30
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Variceal Bleeding

Keywords

a removable titanium clip

Brief summary

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

DEVICEa removable titanium clip

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

Sponsors

Shupei Li
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. The patient and their family agree to and sign the relevant informed consent form. 2. Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations. 3. History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding. 4. Patients confirmed by endoscopy to have bleeding from ruptured gastric varices. 5. Patients who are hemodynamically stable before or after initial fluid resuscitation. 6. Aged 18 to 75 years.

Exclusion criteria

1. Those with concomitant bleeding from ruptured esophageal varices. 2. A history of gastrointestinal-related surgical procedures. 3. Individuals with altered consciousness who are difficult to treat. 4. Those with concomitant malignant tumors. 5. Individuals with serious diseases involving the heart, brain, lungs, or kidneys. 6. Pregnant and breastfeeding women. 7. Those with contraindications to relevant treatments.

Design outcomes

Primary

MeasureTime frameDescription
Rebleeding rate within 5 days after treatmentwithin 5 days after treatmentSigns of rebleeding: A clinically significant event of active bleeding after hemostasis (hematemesis, melena, or rectal bleeding; a decrease in systolic blood pressure of \>20 mmHg or an increase in heart rate of \>20 beats/min; a drop in hemoglobin of \>30 g/L without blood transfusion). (1) Early rebleeding: Occurs within 120 hours to 6 weeks after hemostasis. (2) Delayed rebleeding: Occurs more than 6 weeks after hemostasis. Non-EVB patients are excluded.

Countries

China

Contacts

Primary ContactChangqing Sun
18851675250@163.com18851675250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026