Optimal Time for Follow up After Variceal Band Ligation | NCT04602663

Studies
Optimal Time for Follow up After Variceal Band Ligation

NCT04602663

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Oct 26, 2020Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Esophageal Varices

Interventions

Esophageal Variceal Band ligation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 20, 2020

First Submission Date that Met QC Criteria

Oct 20, 2020

First Posted Date

Oct 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2020

Last Update Posted Date

Oct 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined. So, we designed this trial to answer this question.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Esophageal Variceal Band ligation	Device	Band ligation of OV	follow up every 2 weeks follow up every 3 weeks follow up every 4 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with eradicated varices	The total number of patients with eradicated varices	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

non-cirrhotic portal hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201147773440		sheriefabdelsalam@yahoo.com
Mohamed Alboraie, MD	Contact	0020106445739		sheriefabdelsalam@gmail.com

Overall Officials

Name	Affiliation	Role
Mohamed Alboraie, MD	Al-Azhar University	Principal Investigator
Ahmed Maher, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004932	Esophageal and Gastric Varices

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006975	Hypertension, Portal

Browse Leaves

Not provided

Browse Branches

Not provided