Carvedilol Versus Endoscopic Band Ligation for Primary Pr... | NCT04499898

Studies
Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

NCT04499898

Sponsor

Sherief Abd-Elsalam

Status

Recruiting

Last Update Posted

Aug 5, 2020Actual

Enrollment

306Estimated

Phase

Phase 2Phase 3

Conditions

Esophageal Varices

Interventions

Carvedilol
Endoscopic 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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 10, 2030Estimated

First Submitted Date

Aug 1, 2020

First Submission Date that Met QC Criteria

Aug 1, 2020

First Posted Date

Aug 5, 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

Aug 1, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Detailed Description

A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
carvedilol	Experimental	Carvedilol	Drug: Carvedilol
Band Ligation	Active Comparator	Band Ligation	Procedure: Endoscopic band ligation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carvedilol	Drug	Carvedilol	carvedilol	carvid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with the first variceal bleeding within 1 year	The number of patients with the first variceal bleeding within 1 year	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Aged >18 years
- Cirrhotic patients with arterial hypertension
- Endoscopic evidence of medium/large-sized esophageal varices

Exclusion Criteria:

• History of variceal bleeding or previous primary prevention of varices.
- Portal vein thrombosis or previous porto-systemic shunts as TIPS.
- Patients on drugs affecting portal pressure (beta blockers, nitrates).
- Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
- Patients with severe respiratory diseases (COPD, bronchial asthma).
- Uncontrolled diabetes mellitus
- Renal impairment
- Hepatocellular carcinoma
- Allergy to carvedilol
- Pregnancy or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com
Nabila el-gazzar, ass. lect.	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Asem Elfert, Prof	Tanta University - Faculty of Medicine	Study Director
Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect	Tanta University Faculty of medicine	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

Intervention Browse Module

MeSH Terms

ID	Term
D000077261	Carvedilol

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided