Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding

Acute Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031402
• Other study ID #: XHNKKY-ENDO-AVB
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: General Hospital of Shenyang Military Region
• Contact: Xingshun Qi, MD
• Phone: 86-18909881019
• Email: xingshunqi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 368
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Bleeding
• Acute Variceal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Procedure:
• Endoscopy
Endoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

References & Publications (4)

Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282. — View Citation

Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524. — View Citation

Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015. — View Citation

Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The failure to control bleeding after admissions	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.	within 5 days admission
Primary	6-week rebleeding	Rebleeding is defined as new onset of hematemesis or melena after successful treatment.	6-week
Secondary	6-week all-cause mortality	Death.	6-week
Secondary	Adverse events	Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.	up to 6 weeks