NCT05131802|Completed
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Sponsor study identifier
observational
288
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
December 15, 2020
Actual (reported)Study Completion
December 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)December 15, 2020
Actual (reported)December 15, 2020
Actual (reported)November 9, 2021
Actual (reported)November 23, 2021
Actual (reported)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.
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.
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
10 minutes for endoscopy for gastric fluid collection
which included patients that had undergone cholecystectomy.
included patients who had undergone at least one of the following procedures for treatment of benign pathology: endoscopic sphincterotomy (ES) and endoscopic stenting.
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®).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients who were admitted to the university hospitals with inclusion criteria
Zagazig University Hospitals
Zagazig, Sharqia Province, 44511, Egypt
Eldredge TA, Myers JC, Kiroff GK, Shenfine J. Detecting Bile Reflux-the Enigma of Bariatric Surgery. Obes Surg. 2018 Feb;28(2):559-566. doi: 10.1007/s11695-017-3026-6.
Vere CC, Cazacu S, Comanescu V, Mogoanta L, Rogoveanu I, Ciurea T. Endoscopical and histological features in bile reflux gastritis. Rom J Morphol Embryol. 2005;46(4):269-74.
Sun D, Wang X, Gai Z, Song X, Jia X, Tian H. Bile acids but not acidic acids induce Barrett's esophagus. Int J Clin Exp Pathol. 2015 Feb 1;8(2):1384-92. eCollection 2015.
Amira A Othman, Ph. D
Zagazig University Hospitals
288 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2021
First Posted
November 23, 2021
Study Start
January 1, 2018
Actual (reported)gastric juice pH
Upper GIT endoscopy is performed and gastric fluid is aspirated to detect gastric juice pH
10 minutes for endoscopy for gastric fluid collection
Contact the study team to confirm eligibility.
Kuran S, Parlak E, Aydog G, Kacar S, Sasmaz N, Ozden A, Sahin B. Bile reflux index after therapeutic biliary procedures. BMC Gastroenterol. 2008 Feb 11;8:4. doi: 10.1186/1471-230X-8-4.
Monaco L, Brillantino A, Torelli F, Schettino M, Izzo G, Cosenza A, Di Martino N. Prevalence of bile reflux in gastroesophageal reflux disease patients not responsive to proton pump inhibitors. World J Gastroenterol. 2009 Jan 21;15(3):334-8. doi: 10.3748/wjg.15.334.
Primary Completion
December 15, 2020
Actual (reported)Study Completion
December 15, 2020
Actual (reported)Last Updated
December 8, 2021
Record last verified: 2021-11
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