Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding

NCT06214234 | Unknown

• 1 other identifier: Shadn Protocol
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• in-hospital bleeding

  Frequency of mortality in patients with variceal bleeding

  One year

Study Arms (2)

Early band ligation

OTHER

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

Procedure: Band ligation

Delayed band ligation

OTHER

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

Procedure: Band ligation

Interventions

Band ligation PROCEDURE

Band ligation in variceal bleeding

Delayed band ligation; Early band ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35477727 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Study Officials

• Shaden Kelany, MSc

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Shaden Kelany, MSc

CONTACT

01024817165; shadenahmed997@gmail.com

Ahmed M Abu-Elfatth, MD

CONTACT

+18677791; ahmed111@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patient will be enrolled in one each group without masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups of patients present with variceal bleeding

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 28, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)