Back to resultsCarvedilol 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
About this trial
This is an interventional prevention trial for Esophageal Varices
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
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
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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