Ulcer Bleeding After Band Ligation of Esophageal Varices

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06082219

Collaborator

(none)

130

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Varices

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 Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients' age is 18 years or above.
Patient who are diagnosed with esophageal varices by upper endoscopy.
Patient who are fit for surgery to undergo endoscopic banding procedure.

Exclusion Criteria:

Pediatric patients.
patient refuse to participate at this study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Amna Esmail Mohamed Tammam, Assiut University
Study Director: Essam Abdelmonem Sadek, Assiut University
Study Director: Muhammad Abbas Said El-Masry, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amna Esmail Mohamed Tamam, doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT06082219

Other Study ID Numbers:

Post banding ulcer bleeding

First Posted:

Oct 13, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Additional relevant MeSH terms:

Esophageal and Gastric Varices

Varicose Veins

Study Results

No Results Posted as of Oct 16, 2023