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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2027-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gastric Variceal Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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a removable titanium clip

Group Type EXPERIMENTAL

a removable titanium clip

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No