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.: PACTR201809484430035 Date of Approval: 14/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title von Willebrand Factor and Esophageal Varices in Children with Chronic Liver Disease
Official scientific title title:von Willebrand Factor and Esophageal Varices in Children with Chronic Liver Disease
Brief summary describing the background and objectives of the trial The majority of patients who suffer from cirrhosis die due to complications of increased portal venous pressure, such as variceal hemorrhage, ascites, hepatic encephalopathy (HE), hepatopulmonary syndrome (HPS) or hepatorenal syndrome. Portal hypertension (PH) is one of the main consequences of CLD. Because of progressive liver tissue fibrogenesis, intrahepatic vasculature is remodelled in CLD, which would lead to increased hepatic resistance. This mechanism is responsible for the development of PH, which is defined as increased portal venous pressure ≥ 5mmHg.The degree of EVs is a relevant prognostic factor in patients with cirrhosis. Therefore, early diagnosis of the EVs is very important. Clinically significant portal hypertension (CSPH), defined as hepatic venous pressure gradient (HVPG) ≥10 mmHg, increases the risk of liver-related mortality and PH-related complications as well as the risk of developing hepatocellular carcinoma. Hepatic venous pressure gradient and esophagogastroduodenoscopy (EGD) are considered to be the gold standard for diagnosis of PH and EVs in cirrhotic patients, but both are invasive and expensive procedures that may be associated with potential complications and are not accepted by many patients. von Willibrand factor plays a crucial role in primary hemostasis and is an indicator of endothelial activation and development of thrombotic vascular obliteration and possible mechanism of pH. The aim of this work was to evaluate the role of plasma level of von Willebrand factor antigen as a possible predictor for the presence of esophageal varices in children with chronic liver diseases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/06/2016
Actual trial start date 01/06/2016
Anticipated date of last follow up 31/07/2017
Actual Last follow-up date 31/07/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vWF Once The concentration of (vWF-Ag) in plasma samples were evaluated using Enzyme-Linked Immunosorbent Assay for human vWF-Ag Test Kit, catalog NO. (vWF-Ag Kit 034-001) GS1 (Corgenix Medical Corporation, USA). 50
Control Group Upper endoscopy Once Diagnostic upper endoscopy was performed after at least 6 hours fasting, young infants were supported by intravenous fluid during fasting. Sedation using midazolam (0.3 mg / Kg / dose) was sometimes used followed by propofol (diprivan) in a dose of (1 mg/kg IV). The child was put on his left lateral position; endoscopy was introduced through mouth till it reaches the second part of the duodenum. Complete examination for esophagus, stomach and duodenum using Olympus GIF-H170 device with light source CLV-U40 and Processor C.V 240. During examination, oxygen saturation and pulse rate were continuously monitored using pulse oximetry. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with CLDs referred to the Pediatric Hepatology, Gastroenterology and Nutrition Department, undergo for the first time diagnostic upper endoscopy with no previous intervention endoscopic maneuver. Patients documented having esophageal varices & on sclerotherapy. Patients received medical treatment as primary prophylaxis for esophageal variceal bleeding. Patients with cardiopulmonary failure. Patients with renal failure. Patients presented by active infection. Well known cases of von Willibrand disease. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 18 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 15/06/2017 IRB National Liver Institue Menofyia University
Ethics Committee Address
Street address City Postal code Country
Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Esophageal varices after upper endoscopy
Secondary Outcome Plasma vWF-Ag level after samples withdrwal and analysis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Abdel Salam ElGuindi Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Nermin Mohammed Ali Adawy Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Hosam Eldin Mohammed Basiouny Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Iman Shaban Osheba Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Wafaa Masoud Khalifa Hussein Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Nermin Adawy dr.nerminadawy@gmail.com 00201006662474 54 Zeinah Street As Soyouf Bahri Qism El-Montaza
City Postal code Country Position/Affiliation
Alexandria 21533 Egypt Assistant Professor of Pediatric Hepatology Gastroenterology and Nutrition National Liver Institute Menoufia University
Role Name Email Phone Street address
Principal Investigator Mohamed ElGuindi elguindi1@yahoo.com 00222137992 25 road 84 Maadi
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Professor of Pediatric Hepatology Gastroenterology and Nutrition National Liver Institute Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information