Clinical trial NCT06214234: Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding
Official title: Timing of Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding: Urgent vs. Elective Endoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophageal Varices
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients present with variceal bleeding
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: in-hospital bleeding
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Shaden Kelany, MSc
role: STUDY_DIRECTOR
References:
citation: Kim J, Gong EJ, Seo M, Park JK, Lee SJ, Han KH, Kim YD, Jeong WJ, Cheon GJ, Seo HI. Timing of endoscopy in patients with upper gastrointestinal bleeding. Sci Rep. 2022 Apr 27;12(1):6833. doi: 10.1038/s41598-022-10897-3.