Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding (Varices)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Varices
• Intervention / Treatment: Procedure: Band ligation

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaden Kelany, MSc; Phone Number: 002 01024817165; Email: shadenahmed997@gmail.com
• Study Contact Backup: Name: Ahmed M Abu-Elfatth, MD; Phone Number: +18677791; Email: ahmed111@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University
    • Contact: Shaden Kelany, MSc; Phone Number: 002 01024817165; Email: shadenahmed997@gmail.com
    • Contact: Ahmed M Abu-Elfatth, MD; Phone Number: +18677791; Email: ahmed111@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Early band ligation; Patients with liver cirrhosis present with variceal bleeding underwent band ligation within 12 hours of presentation	Procedure: Band ligation; Band ligation in variceal bleeding
Other: Delayed band ligation; Patients with liver cirrhosis present with variceal bleeding underwent band ligation within more than 12 hours of presentation	Procedure: Band ligation; Band ligation in variceal bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital bleeding	Frequency of mortality in patients with variceal bleeding	One year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Shaden Kelany, MSc, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage
• Other Study ID Numbers: Shadn Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No