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Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding

Timing of Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding: Urgent vs. Elective Endoscopy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06214234
Acronym
Varices
Enrollment
60
Registered
2024-01-19
Start date
2024-02-01
Completion date
2025-02-28
Last updated
2024-01-19

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

Conditions

Esophageal Varices

Brief summary

Liver cirrhosis is a common diffuse and persistent liver disease often accompanied by portal hypertension, liver failure, upper gastrointestinal bleeding (UGIB), and other complications. The incidence rate of liver cirrhosis with UGIB is as high as 30-40%, which is related to the rupture bleeding of gastroesophageal varices (GOV), hepatogenic ulcer, portal hypertensive gastropathy, hepatic gastrointestinal failure, etc

Detailed description

In the case of UGIB in patients with liver cirrhosis, acute peripheral circulatory failure may suddenly occur, resulting in decreased blood perfusion in liver tissues, often accompanied by clinical manifestations such as blood volume decline, melena, and haematemesis. This disease progresses rapidly, with a mortality rate of above 10% if not treated promptly Timing of endoscopy in the management of acute upper gastrointestinal bleeding (AUGIB) has been a subject of perennial debate. Despite remarkable advancements in endoscopic treatments and substantial efforts in reducing mortality, the overall in-hospital mortality rate associated with UGIB is still estimated to be 10%. Several studies have investigated the clinical impact of urgent (within 6 h of presentation) or early (within 12 h) endoscopy on mortality in patients with UGIB. Some studies showed no significant difference in mortality rate between urgent and elective endoscopy groups among high-risk patients with acute UGIB In contrast, others found that urgent endoscopy was associated with a lower mortality rate in high-risk patients with acute non-variceal UGIB. Most of the previous studies included highly selected patients with non-variceal UGIB or those at a high risk. However, given that the definitive diagnosis is made after endoscopic examination, these studies may not reflect real-world clinical practice. Furthermore, it is often challenging to predict the cause of bleeding and to identify patients at high risk who require intensive care based on their symptoms and the information obtained in the emergency room

Interventions

PROCEDUREBand ligation

Band ligation in variceal bleeding

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Patient will be enrolled in one each group without masking

Intervention model description

Two groups of patients present with variceal bleeding

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Any patient who is above age of 18 years old and with liver cirrhosis and present with UGIB will be eligible for the study

Exclusion criteria

* Patients with age less than 18 years old * Non-cirrhotic patients * Patients with hemodynamic instability * Patient's refusal

Design outcomes

Primary

MeasureTime frameDescription
in-hospital bleedingOne yearFrequency of mortality in patients with variceal bleeding

Countries

Egypt

Contacts

Primary ContactShaden Kelany, MSc
shadenahmed997@gmail.com01024817165
Backup ContactAhmed M Abu-Elfatth, MD
ahmed111@aun.edu.eg+18677791

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026