Skip to content

A multicenter, randomized controlled clinical study of self-expanding metal stents in the treatment of acute esophageal variceal hemorrhage

A multicenter, randomized controlled clinical study of self-expanding metal stents in the treatment of acute esophageal variceal hemorrhage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085010
Enrollment
Unknown
Registered
2024-05-29
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Esophageal variceal bleeding

Interventions

Stent set:Use an esophageal stent to stop bleeding
Banding set:Treatment is done with banding

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 for this trial; 2) patients with diagnosis of liver cirrhosis based on clinical manifestations, laboratory tests, imaging examinations or liver biopsy; 3) Symptoms related to acute variceal upper gastrointestinal bleeding, such as hematemesis/melena/hematochezia, etc. before or during hospitalization (regardless of previous bleeding history); 4) Patients with endoscopic confirmation of esophageal variceal bleeding; 5) hemodynamically stable patients 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, etc.; 2) tracheoesophageal fistula; 3) esophageal rupture; 4) Tumors of the pharynx, larynx, esophagus, stomach or upper respiratory tract; 5) esophageal stricture; 6) recent esophageal surgery; 7) pregnancy or breastfeeding; 8) Those who cannot be selected for any reason in the opinion of the researcher.

Design outcomes

Primary

MeasureTime frame
Rate of hemostasis at 5 days after treatment of acute esophageal variceal bleeding;

Secondary

MeasureTime frame
Characteristics of the patient population;Duration of the procedure;The stent is left in place;Rescue therapy such as blood transfusion and TIPS;Stent dwelling time;Rate of hemostasis at 6 weeks after treatment;Mortality at 5 days and 6 weeks after treatment;Child score and MELD score before and after stent treatment;Incidence of adverse events;Rebleeding rate;Endoscopic manifestations of varices before and after secondary prevention, rebleeding rate;Cost-effectiveness, e.g., length of hospital stay, hospitalization costs, total medical 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