Using a removable titanium clip to treat acute gastric variceal bleeding

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

This study is testing a new removable titanium clip to see if it can help stop severe bleeding from stomach varices in patients when other treatments aren't possible.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06736314 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of a removable titanium clip to control acute bleeding from gastric varices. The clip is applied to block the bleeding vessels, allowing for rapid hemostasis, and is removed after five days to prevent complications with future imaging or treatments. This method serves as a temporary solution when other emergency treatments are not feasible, potentially stabilizing patients until further interventions can be performed. The study aims to evaluate the effectiveness and safety of this innovative approach in managing a critical condition.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with cirrhosis and confirmed bleeding from gastric varices.

Not a fit: Patients with concurrent bleeding from esophageal varices or serious comorbid conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a life-saving option for patients experiencing acute gastric variceal hemorrhage.

How similar studies have performed: While this approach is innovative, similar studies using temporary devices for hemostasis have shown promise in other contexts.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Removable Titanium Clip — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Changqing Sun

Conditions Gastric Variceal Bleeding; a removable titanium clip