Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding

NCT ID: NCT06214234

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-28

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

Conditions

Esophageal Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early band ligation

Patients with liver cirrhosis present with variceal bleeding underwent band ligation within 12 hours of presentation

Group Type: OTHER

Band ligation

Intervention Type: PROCEDURE

Band ligation in variceal bleeding

Delayed band ligation

Patients with liver cirrhosis present with variceal bleeding underwent band ligation within more than 12 hours of presentation

Group Type: OTHER

Band ligation

Intervention Type: PROCEDURE

Band ligation in variceal bleeding

Interventions

Band ligation

Band ligation in variceal bleeding

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shadn Ahmed Keilany

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaden Kelany, MSc

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Shaden Kelany, MSc

Role: CONTACT

shadenahmed997@gmail.com

01024817165 ext. 002

Ahmed M Abu-Elfatth, MD

Role: CONTACT

ahmed111@aun.edu.eg

+18677791

Facility Contacts

Shaden Kelany, MSc

Role: primary

shadenahmed997@gmail.com

01024817165 ext. 002

Ahmed M Abu-Elfatth, MD

Role: backup

ahmed111@aun.edu.eg

+18677791

References

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.

Reference Type: BACKGROUND

PMID: 35477727 (View on PubMed)

Other Identifiers

Shadn Protocol

Identifier Type: -

Identifier Source: org_study_id