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.: PACTR201804003346216 Date of Approval: 23/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gastric Antral Vascular Ectasia in Portal Hypertensive children:Endoscopic Band Ligation vs Argon Plasma Coagulation
Official scientific title Gastric Antral Vascular Ectasia in Portal Hypertensive children:Endoscopic Band Ligation versus Argon Plasma Coagulation
Brief summary describing the background and objectives of the trial Objectives: Gastric antral vascular ectasia (GAVE) can cause recurrent bleeding and chronic anemia in children with portal hypertension (PHT). Endoscopic band ligation (EBL) was thought to be a good alternative choice in management of refractory GAVE. We aimed to evaluate the efficacy of EBL in comparison to argon plasma coagulation (APC) in children with PHT, bleeding from GAVE. Methods: This prospective observational comparative study included 40 children with PHT who presented with non-variceal GIT bleeding from GAVE, attending Endoscopy unit. Patients were divided into 2 groups, each including 20 cases: one group were managed with APC and the other with EBL. Endoscopy was repeated every 3-4 weeks until complete ablation of GAVE was achieved. Patients were re-evaluated earlier in the event of recurrence of bleeding (hematemsis and/or melena) or in case of severe anemia necessitating blood transfusion. A follow-up endoscopy was done 6 months after the last APC or EBL session to assess the recurrence of GAVE. Results: The ages ranged between 2 to 16 years and 60% were males. The EBL group required a significantly lower number of sessions for complete obliteration of the lesions (1.85±0.81) as compared to APC group (4.15±1.22), p<0.05. EBL was superior to APC as regards; shorter procedure time (p=0.001), lower blood transfusion requirement (p<0.05), less hospitalization (p<0.05) and significantly lower recurrence rate of GAVE after 6 months follow up (p=0.01) Conclusions: EBL is more effective and more time saving when compared to APC in treatment of bleeding from GAVE in children. Keywords: Argon plasma coagulation; Children; Endoscopic band ligation; Gastric antral vascular ectasia; Portal hypertension
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Digestive System,Portal hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/01/2016
Actual trial start date 06/01/2016
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 24/06/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 research randomizer program (http://www.randomizer.org/form.htm) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Research randomizer program (http://www.randomizer.org/form.htm) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Argon Plasma Coagulation Sessions every 4 weeks For approximately 6 months Endoscopic intervention 20
Experimental Group Endoscopic Band Ligation Sessions every 4 weeks For approximately 6 months Endoscopic intervention 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Children with portal hypertension. -Evidence of upper GI bleeding. -Endoscopic evidence of non-variceal bleeding. -Normal coagulation pro¿le. -Normal platelet count above 80,000/mm3. -Patients who had another possible source of upper GI bleeding other than GAVE.(eg. ulcer) -Patients had GAVE associated with other medical conditions rather than portal hypertension. -Patients had esophageal/gastric varices. 2 Year(s) 16 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 23/07/2018 Research Ethics Committee of Pediatrics Department, Faculty of Medicine, Cairo University, Egypt
Ethics Committee Address
Street address City Postal code Country
1 Ali Ibrahium Basha Street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stoppage of bleeding from GAVE 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hepatology research Institute 10 Kasr Al-Aini street Cairo 11441 Egypt
Pediatric Endoscopy Unit, Cairo University Pediatric Hospital. 1 Ali Ibrahium Basha Street, El-Sayda Zeinab Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Endoscopy Unit, Cairo University Pediatric Hospital 1 Ali Ibrahium Basha Street Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Pediatric Hospital 1 Ali Ibrahium Basha Street Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabil Abd El aziz Mohsen 1 Ali Ibrahium Basha Street Cairo 11562 Egypt
Ayman Emil Eskander 1 Ali Ibrahium Basha Street Cairo 11562 Egypt
Carolyne Morcos Ibrahim Ghobrial 1 Ali Ibrahium Basha Street Cairo 11562 Egypt
Mohamed Ahmed Rabea 10 Kasr Al-Aini street Cairo 11441 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Eskander dr.Aymanemil@yahoo.com 0020 01223993369 1 Ali Ibrahium Basha Street, Cairo University Pediatric Hospital
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Professor of Pediatrics, Faculty of Medicine, Cairo University
Role Name Email Phone Street address
Public Enquiries Nabil Mohsen mohsennabil2000@yahoo.com 0020 01001407973 1 Ali Ibrahium Basha Street, Cairo University Pediatric Hospital
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Professor of Pediatrics, Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Carolyne Ghobrial cmiga82@yahoo.com 0020 01222644208 1 Ali Ibrahium Basha Street, Cairo University Pediatric Hospital
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Lecturer of Pediatrics, Faculty of Medicine Cairo University.
REPORTING
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