Ulcer Bleeding After Band Ligation of Esophageal Varices

Esophageal Varices Clinical Trial

Official title:

Ulcer Bleeding After Band Ligation of Esophageal Varices:Risk Factors and Prognosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082219
• Other study ID #: Post banding ulcer bleeding
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Amna Esmail Mohamed Tammam
• Phone: +20 1145547952
• Email: amnaesmail.145[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Primary Outcomes:

assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.

Secondary Outcomes:

minimize post-banding ulcer bleeding

Description:

Esophageal variceal bleeding represents the most vital complication among patients with liver cirrhosis at rate of 5-15% per year. Endoscopic variceal ligation (EVL), either used as therapeutic in emergency or as prophylactic, is one of the best modalities used in EV treatment. The procedure is effective and generally safe. After banding, a superficial ulcer is formed, which usually heals in 2-3 weeks. The main complications of variceal banding are pain, dysphagia, fever, bleeding during the procedure and post banding ulcer bleeding (PBUB). The prevalence of PBUB is reported to be 3.6-15% . Rebleeding can be fatal, and is mainly resulted from early spontaneous slippage of the rubber bands, before occlusion of the varix with a mature thrombus, leaving an unhealed ulcer . The time frame of variceal rebleeding can be divided into very early rebleeding (within 5 days of acute bleeding), early rebleeding (within 6 weeks of acute bleeding), and delayed rebleeding. Previous reports showed that early rebleeding ranged from 30% to 40% within the first 6 weeks, and was significantly associated with the risk of death within 6 weeks. Therefore, the aim of this research is assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis, in order to minimize post-banding ulcer bleeding.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients' age is 18 years or above.

2. Patient who are diagnosed with esophageal varices by upper endoscopy.

3. Patient who are fit for surgery to undergo endoscopic banding procedure.

Exclusion Criteria:

1. Pediatric patients.

2. patient refuse to participate at this study

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Varicose Veins

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.	assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.	Baseline