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

Primary Purpose

Esophageal Varices

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Carvedilol
Endoscopic band ligation
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

carvedilol

Band Ligation

Arm Description

Carvedilol

Band Ligation

Outcomes

Primary Outcome Measures

Number of patients with the first variceal bleeding within 1 year
The number of patients with the first variceal bleeding within 1 year

Secondary Outcome Measures

Full Information

First Posted
August 1, 2020
Last Updated
August 1, 2020
Sponsor
Sherief Abd-Elsalam
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1. Study Identification

Unique Protocol Identification Number
NCT04499898
Brief Title
Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding
Official Title
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 10, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carvedilol
Arm Type
Experimental
Arm Description
Carvedilol
Arm Title
Band Ligation
Arm Type
Active Comparator
Arm Description
Band Ligation
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
carvid
Intervention Description
Carvedilol
Intervention Type
Procedure
Intervention Name(s)
Endoscopic band ligation
Other Intervention Name(s)
band ligation
Intervention Description
Endoscopic band ligation
Primary Outcome Measure Information:
Title
Number of patients with the first variceal bleeding within 1 year
Description
The number of patients with the first variceal bleeding within 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nabila el-gazzar, ass. lect.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem Elfert, Prof
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect
Organizational Affiliation
Tanta University Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sherief abd-elsalam, ass. prof
Phone
00201147773440
Email
sheroefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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