An observational study in Dyspepsia, Heartburn and Bile Reflux, sponsored by Zagazig University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by Zagazig University · Observational
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.
Bile reflux gastropathy is a pathological condition in the form of the backward flow of duodenal fluid that consists of bile, pancreatic juices, and secretions of the intestinal mucosa into the stomach and esophagus, causing mucosal lesions. Bile acids, in combination with gastric acid, have been shown to cause bile reflux gastropathy symptoms (heartburn, regurgitation, epigastric pain, etc.).
Bile reflux gastropathy frequently occurs after gastric surgeries that that damages the pyloric sphincter, and after biliary surgeries and procedures as cholecystectomy, endoscopic sphincterotomy (EST), endoscopic stenting, or choledochoduodenostomy that cause the sphincter of Oddi malfunction.[4] Bile gastropathy is a normal physiological event in a prolonged fasting period (primary bile reflux gastropathy).In non-responsive individuals to PPI medication, the total prevalence of biliary reflux was 68.7%. These people have acid and bile reflux at the same time and have never had biliary surgery.
Endoscopic retrograde cholangiopancreatography (ERCP) became an increasingly popular modality for both the diagnosis and the treatment of biliary tract disorders. It represents one of the most demanding and technically challenging procedures in gastrointestinal endoscopy, which must be performed effectively and safely by operators with substantial training and experience to maximize success and safety. Cholecystectomy is a surgical operation of gallbladder removal. It can be performed either laparoscopically, using a video camera, or via an open surgical technique. Pain and complications caused by gallstones are the most common reasons for cholecystectomy.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's enrollment of 288 is above the median of 200 across 62 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients who were admitted to the university hospitals with inclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
which included patients that had undergone cholecystectomy.
Device: upper GIT endescopy
included patients who had undergone at least one of the following procedures for treatment of benign pathology: endoscopic sphincterotomy (ES) and endoscopic stenting.
Device: upper GIT endescopy
Gastric mucosa alterations as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae were also recorded (Olympus single-channel CLK-4). Multiple biopsies were taken from gastric mucosa for histopathological study. Via Triple Lumen ERCP Cannula, 5 mL of gastric fluid was aspirated through the suction channel of the endoscope and collected in a sterile trap placed in the suction line, to be sent for analysis. Quantitative determination of gastric aspirate total bilirubin level was performed (Gen.3® kit and Cobas 8000 analyzer). The pH monitoring of gastric aspirate was performed during the gastroscopy just after collection with a glass electrode pH meter (Adwa®).
gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.
Upper GIT endoscopy is performed and by which gastric mucosa changes were recorded; as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.
Time frame: 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.
Upper GIT endoscopy is performed and by which gastric mucosal biopsies were taken from lesion sites for histopathological study, as chronic inflammation, foveolar hyperplasia , chronic Atrophic gastritis, bile stasis, interstitial inflammation, edema, intestinal metaplasia, and acute inflammation.
Time frame: 7 minutes for endoscopy for biopsy taken
intragastric total bilirubin level
Upper GIT endoscopy is performed and gastric fluid is aspirated for quantitative analysis of gastric aspirate total bilirubin level
Time frame: 10 minutes for endoscopy for gastric fluid collection
gastric juice pH
Upper GIT endoscopy is performed and gastric fluid is aspirated to detect gastric juice pH
Time frame: 10 minutes for endoscopy for gastric fluid collection
Plan to share: No — to keep participant privacy
Ran from Jan 2018 to primary completion in Dec 2020, 35 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.