NCT04602663

Brief Summary

Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 20, 2020

Last Update Submit

October 20, 2020

Conditions

Esophageal Varices

Outcome Measures

Primary Outcomes (1)

  • Number of patients with eradicated varices

    The total number of patients with eradicated varices

    1 year

Study Arms (4)

follow up every week

EXPERIMENTAL

Variceal Band ligation every week.

Device: Esophageal Variceal Band ligation

follow up every 2 weeks

EXPERIMENTAL

Variceal Band ligation every 2 weeks

Device: Esophageal Variceal Band ligation

follow up every 3 weeks

EXPERIMENTAL

Variceal Band ligation every 3 weeks

Device: Esophageal Variceal Band ligation

follow up every 4 weeks

EXPERIMENTAL

Variceal Band ligation every 4 weeks

Device: Esophageal Variceal Band ligation

Interventions

Esophageal Variceal Band ligationDEVICE

Band ligation of OV

Also known as: Band ligation
follow up every 2 weeksfollow up every 3 weeksfollow up every 4 weeksfollow up every week

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding

You may not qualify if:

  • non-cirrhotic portal hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Mohamed Alboraie, MD

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • Ahmed Maher, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Mohamed Alboraie, MD

CONTACT

0020106445739sheriefabdelsalam@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 31, 2021

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)