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

Shupei Li

Status: Enrolling

Conditions: Gastric Variceal Bleeding

Treatments: Device: a removable titanium clip

Study type: Interventional

Funder types: Other

Identifiers

NCT06736314

DZQH-KYLLFS-24-26

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

a removable titanium clip

Experimental group

Treatment:

Device: a removable titanium clip