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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06082219
Other study ID # Post banding ulcer bleeding
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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