Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008491799224 Date of Registration: 27/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PROPHYLAXIS OF NON BLEEDING GASTRIC VARICES.
Official scientific title PROPHYLACTIC CYANOACRYLATE INJECTION FOR GASTRIC EXTENSION OF ESOPHAGEAL VARICES TYPE II: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: Gastroesophageal varices is a major and dangerous complication of chronic liver disease. Bleeding from gastric varices is more severe and has higher mortality than esophageal. Cyanoacrylate injection of bleeding gastric varices is recommended, however prophylactic injection of gastric varices is debatable. The aim of this study was to evaluate prophylactic cyanoacrylate injection for gastric extension of esophageal varices type II ( GOV II) with esophageal varices band ligation (EBL) in comparison to esophageal variceal band ligation with and without beta blocker (BB).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date 15/12/2019
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endoscopic Cyanoacrylate injection of gastric variceal extension type II Number of ampoules will be determined according to size of gastric extension 24 weeks Cyanoacrylate is a tissue glue commonly used for treatment of bleeding gastric varices by endoscopic injection of gastric varices. It causes obturation of the varices with stopping of bleeding. 25
Control Group Esophageal variceal band ligation and Carvedilol Esophageal variceal band ligation (Number of bands is determined by size and number of esopahageal varices). Follow up session will be each 4 weeks till esophageal variceal eradication. Carvedilol dose started with 6.25 mg tablet daily and escalated according to monitoring of pulse and blood pressure. Duration of esophageal variceal band ligation till eradication of esophageal varices. Duration of carvedilol till end of follow up. Band ligation is used through endoscopic multiband ligator 25 Active-Treatment of Control Group
Control Group Endoscopic esophageal variceal band ligation Number of bands is determined by number and size of esophageal varices. Follow up till eradication of varices Endoscopic multiband ligator 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All cirrhotic patients who will present with healthy non bleeding gastric varices associated with bleeding or high risky esophageal varices will be included in the study. - Patient who refused to be enrolled in our study. Patients with active or previously bled from gastric varices. or have - Impending to bleed gastric varices - Patients who have any contraindication to beta blockers. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/01/2016 Benha Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Farid Nada St Benha 31518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome GI bleeding Since intervention till end of follow up
Secondary Outcome Changes in size or risk of gastric varices each 4 weeks till 24 weeks or eradication of esophageal varices
Secondary Outcome Changes in portal hypertensive gastropathy each 4 weeks till 24 weeks or eradication of esophageal varices
Secondary Outcome Mortality 24 weeks follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hepatology and Gastroenterology Department Benha Faculty of Medicine Farid Nada St Benha 31518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha Univerisity Farid Nada St. Benha Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha University Hospital Farid Nada St. Benha Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Maher Teaching Hospital 341 Port Said St. Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Metwally mohamed.metwally@fmed.bu.edu.eg 00201064917959 Benha Faculty of Medicine, Farid Nada St
City Postal code Country Position/Affiliation
Benha 31518 Egypt Professor Hepatology Gastroenterology and Infectious Diseases
Role Name Email Phone Street address
Public Enquiries Samer Fathy samerfathi2012@gmail.com 00201065264003 Hepatology and Gastroenterology Dept, Benha University Hospital, Farid Nada St
City Postal code Country Position/Affiliation
Benha Egypt Office director
Role Name Email Phone Street address
Scientific Enquiries Mohamed El shewy mo.elshewi@yahoo.com 00201026624625 Hepatology and Gastroenterology Dept, Benha University Hospital, Farid Nada St
City Postal code Country Position/Affiliation
Benha Egypt Asspciate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD is available upon request from principle investigator (mohamed,metwally@fmed.bu.edu.eg) Informed Consent Form,Statistical Analysis Plan,Study Protocol from August 22, 2020 for two years PACTR, journal editors or reviewers and interested scientific organization can request access to the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 22/08/2020 02/05/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 22/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information