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NCT Number: NCT06736314

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

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Removable Titanium Clip

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Changqing Sun

CONTACT

[email protected]

18851675250

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a removable titanium clip

Device

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

Primary outcomes

  1. Rebleeding rate within 5 days after treatment

    Time frame: within 5 days after treatment

    Signs 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Changqing Sun

CONTACT

[email protected]

18851675250

Sponsors and collaborators

Lead sponsor

Shupei Li

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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