NCT06082219

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 9, 2023

Last Update Submit

October 12, 2023

Conditions

Esophageal Varices

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients having esophageal varices who will undergo endoscopic banding will be included

You may qualify if:

  • 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.

You may not qualify if:

  • Pediatric patients.
  • patient refuse to participate at this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Amna Esmail Mohamed Tammam

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Essam Abdelmonem Sadek

    Assiut University

    STUDY DIRECTOR

  • Muhammad Abbas Said El-Masry

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Amna Esmail Mohamed Tammam

CONTACT

+20 1145547952amnaesmail.145@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

October 16, 2023

Record last verified: 2023-10