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.: PACTR202111578379735 Date of Approval: 18/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Bile Reflux Gastropathy after Therapeutic Biliary Interventions
Official scientific title Bile Reflux Gastropathy: Prevalence and Risk Factors after Therapeutic Biliary Interventions: A Retrospective Cohort Study
Brief summary describing the background and objectives of the trial Bile reflux gastropathy is caused by the backward flow of duodenal fluid into the stomach. A retrospective cohort study was performed to declare if the therapeutic biliary interventions cause bile reflux gastropathy, and to estimate its prevalence and risk factors, and to evaluate the gastric mucosa endoscopic and histopathologic changes.
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date 12/11/2021
Anticipated target sample size (number of participants) 288
Actual target sample size (number of participants) 62
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Upper GIT endoscopy in Post cholecystectomy once 15 minute for endoscopy Upper GIT endoscopy( for recording gastric mucosa finding & biopsy for histopathology and gastric aspirate collection for analysis) in patient had performed cholecystectomy 34 Uncontrolled
Experimental Group ERCP once 30 - 60 minutes Endoscopic retrograde cholangiopancreatography (ERCP) was performed for endoscopic sphincterotomy and endoscopic stenting. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-refractory epigastric pain and dyspeptic symptoms after therapeutic biliary interventions with 2- history of poor response to prokinetics, mucosa-protective medicines, H2-blockers and/or proton-pump inhibitors (PPI). 1- unstable cardiopulmonary, neurologic, or cardiovascular status, 2- other causes of biliary diseases (CBD strictures, and hepatolithiasis), 3- structural abnormalities of the esophagus, stomach, or small intestine, 4- patients who underwent bariatric surgery out of the scope of the study, 5- patients on long-term non-steroidal analgesics, and 6- patients on oral contraceptive drugs. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 24 Year(s) 67 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 01/01/2018 The Zagazig University Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zagazig Zagazig 44511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - prevalence and risk factors of bile reflux Gastropathy Factors after Therapeutic Biliary Interventions, and to evaluate the gastric mucosa endoscopic and histopathologic changes. throughout the internention
Secondary Outcome gastric fluid aspiration for quantitative analysis of gastric aspirate total bilirubin level and pH throughout the internention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zagazig University Hospitals Faculty of Medicine Zagazig Egypt Faculty of Medicine, Zagazig, Egypt Zagazig Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Ahmed Othman Faculty of Medicine, Suez University, Suez, Egypt Suez 43511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zagazig University Hospitals Zagazig, Egypt Zagazig 44511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Othman Amira.Othman@med.suezuni.edu.eg 00201003258097 Faculty of medicine, Suez University, Suez, Egypt
City Postal code Country Position/Affiliation
Suez 43511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Amal Dwedar dewedaramal2021@gmail.com 00201002719185 Zagazig
City Postal code Country Position/Affiliation
Zagazig 44511 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Hany EkSadek hanyelsadek2021@gmail.com 00201021151536 Zagazig
City Postal code Country Position/Affiliation
Zagazig 44511 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data Will be available, All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Oped
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