CompletedNot Applicable

Bile Reflux Gastropathy: Prevalence and Risk Factors After Therapeutic Biliary Interventions

Egypt288 participantsStarted 2018-01-01

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postoperative patients (months to years Postcholecystectomy (Group 1) and therapeutic biliary procedures (Group 2) with persistent upper GIT symptoms ( heartburn, regurgitation dysphagia , dyspepsia ,nausea and epigastric pain) and/or GERD symptoms with history of poor response to prokinetics, mucosa-protective medicines, H2-blockers and/or proton-pump inhibitors (PPI). Exclusion Criteria: * included unstable cardiopulmonary, neurologic, or cardiovascular status, other causes of biliary diseases (CBD strictures, and hepatolithiasis), structural abnormalities of the esophagus, stomach, or small intestine, patients who underwent bariatric surgery out of the scope of the study, patients on long-term non-steroidal analgesics, and patients on oral contraceptive drugs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.

Timeframe: 7 minutes for endoscopy

gastric mucosa histopathological changes as chronic inflammation, foveolar hyperplasia , chronic Atrophic gastritis, bile stasis, interstitial inflammation, edema, intestinal metaplasia, and acute inflammation.

Timeframe: 7 minutes for endoscopy for biopsy taken

intragastric total bilirubin level

Timeframe: 10 minutes for endoscopy for gastric fluid collection

gastric juice pH

Timeframe: 10 minutes for endoscopy for gastric fluid collection

Trial details

NCT IDNCT05131802

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2020-12-15

View on ClinicalTrials.gov More Dyspepsia trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.

Timeframe: 7 minutes for endoscopy

Timeframe: 7 minutes for endoscopy for biopsy taken

intragastric total bilirubin level

Timeframe: 10 minutes for endoscopy for gastric fluid collection

gastric juice pH

Timeframe: 10 minutes for endoscopy for gastric fluid collection