Ulcer Bleeding After Band Ligation of Esophageal Varices

NCT06082219 — Unknown, 130 participants, Assiut University

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

RegistryNCT06082219
StatusUnknown
Study typeObservational
Enrollment130 (Estimated)
SponsorAssiut University (Other)
ConditionsEsophageal Varices
Datesstart 2024-01-01 (estimated), primary completion 2025-01-01 (estimated), completion 2025-03-01 (estimated), first posted 2023-10-13, last updated 2023-10-16

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-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

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+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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Investigators