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An exploratory study of a self-expanding metal stent for the treatment of esophageal variceal bleeding in cirrhosis

An exploratory study of a self-expanding metal stent for the treatment of esophageal variceal bleeding in cirrhosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079882
Enrollment
Unknown
Registered
2024-01-15
Start date
2023-08-30
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Esophageal variceal bleeding

Interventions

Not grouped:Use an esophageal stent to stop bleeding

Sponsors

Eastern Theater General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The subject voluntarily and signed the informed consent form of this trial; (2) Patients diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging tests or liver biopsy; (3) Symptoms related to acute variceal upper gastrointestinal bleeding, such as hematemesis/melena/blood in the stool, before admission or during hospitalization (regardless of previous bleeding history); (4) Patients with endoscopic confirmation of esophageal variceal bleeding; (5) patients with hemodynamically stable before or after initial fluid resuscitation; (6) Age> 18 years old and < 75 years old.

Exclusion criteria

Exclusion criteria: (1) Endoscopic confirmation of non-simple esophageal variceal bleeding, such as gastric variceal bleeding or isolated gastric variceal bleeding; (2) tracheoesophageal fistula; (3) esophageal rupture; (4) Pharyngeal, larynx, esophagus, stomach or upper respiratory tract tumors; (5) esophageal stricture; (6) recent esophageal surgery; (7) pregnancy or breastfeeding; (8) Those who the investigator believes cannot be selected for any reason

Design outcomes

Primary

MeasureTime frame
Hemostasis rate 5 days after treatment;

Secondary

MeasureTime frame
Characteristics of the patient's population, such as type of cirrhosis, complications of cirrhosis, presence or absence of liver cancer;Surgical operation time and stent indwelling site;Whether there is blood transfusion and whether there is rescue treatment such as TIPS;Stent indwelling time;Hemostasis rate 6 weeks after treatment;Mortality at 5 days and 6 weeks after treatment;Child score and MELD score before and after stent treatment;Rate of stent-related adverse events such as stent displacement, dysphagia, aspiration pneumonia, mucosal ulcers, esophageal strictures, perforation, obstruction, infection, etc;Rate of rebleeding after removal of the stent after 5-7 days of treatment;Endoscopic appearance and rebleeding rate of varicose veins before and after secondary prevention;Cost effectiveness, such as length of hospital stay, hospital costs, total healthcare costs during follow-up;

Countries

China

Contacts

Public ContactXuan Ji

Eastern Theater General Hospital

helio0009@126.com+86 138 5194 0720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026