Ulcer Bleeding After Band Ligation of Esophageal Varices

Not yet recruiting

• Conditions: Esophageal Varices

• Registration Number: NCT06082219
• Lead Sponsor: Assiut University

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-16
• Study Start: 2024-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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