Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Conditions
Keywords
liver cirrhosis, variceal bleeding, gastrointestinal bleeding, endoscopy, survival, randomized controlled trial
Brief summary
Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.
Detailed description
A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.
Interventions
PROCEDUREEndoscopy
Endoscopy
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture; 2. patients with a diagnosis of liver cirrhosis based on imaging and pathology; 3. patients and/or their relatives who sign informed consents; 4. patients' age ≥18 years.
Exclusion criteria
1. patients who have undergone endoscopy at other hospitals before admissions; 2. patients' hemodynamics are unstable after resuscitation; 3. patients with severe cardiovascular or cerebrovascular diseases or renal injury; 4. patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases; 5. patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases; 6. patients with mental illness; 7. pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The failure to control bleeding after admissions | within 5 days admission | Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death. |
| 6-week rebleeding | 6-week | Rebleeding is defined as new onset of hematemesis or melena after successful treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-week all-cause mortality | 6-week | Death. |
| Adverse events | up to 6 weeks | Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXingshun Qi, MD
General Hospital of Shenyang Military Area
PRINCIPAL_INVESTIGATORYiling Li, MD
First Hospital of China Medical University
PRINCIPAL_INVESTIGATORBimin Li, MD
The First Affiliated Hospital of Nanchang University
PRINCIPAL_INVESTIGATORXuefeng Luo, MD
West China Hospital
PRINCIPAL_INVESTIGATORXiaofeng Liu, MD
The 960th Hospital of the Chinese People's Liberation Army
PRINCIPAL_INVESTIGATORChunqing Zhang, MD
Affiliated Provincial Hospital of Shandong First Medical University
PRINCIPAL_INVESTIGATORMingkai Chen, MD
People's Hospital of Wuhan University
PRINCIPAL_INVESTIGATORDerun Kong, MD
The First Affiliated Hospital of Anhui Medical University
PRINCIPAL_INVESTIGATORFernando G Romeiro, MD
Botucatu Medical School
PRINCIPAL_INVESTIGATORAndrea Mancuso, MD
Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
PRINCIPAL_INVESTIGATORNahum Méndez-Sánchez, MD
Medica Sur Clinic and Foundation
PRINCIPAL_INVESTIGATOREnqiang Linghu, MD
The First Medical Center of Chinese PLA General Hospital
PRINCIPAL_INVESTIGATORYunhai Wu, MD
The Sixth People's Hospital of Shenyang
PRINCIPAL_INVESTIGATORMetin Basaranoglu, MD
Bezmialem Vakif University
Outcome results
None listed