Bile Reflux Gastropathy after Therapeutic Biliary Interventions
Phase 3
- Conditions
- Digestive System
- Registration Number
- PACTR202111578379735
- Lead Sponsor
- Zagazig University Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
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).
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - prevalence and risk factors of bile reflux Gastropathy Factors after Therapeutic Biliary Interventions, and to evaluate the gastric mucosa endoscopic and histopathologic changes.
- Secondary Outcome Measures
Name Time Method gastric fluid aspiration for quantitative analysis of gastric aspirate total bilirubin level and pH