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.