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

NCT05131802 | Completed

• 1 other identifier: Bile Reflux
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspepsia; Heartburn; Bile Reflux

Keywords

Bile Reflux; Cholecystectomy; ERCP; Bilirubin

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (2)

Postcholecystectomy group

which included patients that had undergone cholecystectomy.

Device: upper GIT endescopy

Biliary intervention group

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

Interventions

upper GIT endescopy DEVICE

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®).

Biliary intervention group; Postcholecystectomy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who were admitted to the university hospitals with inclusion criteria

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (5)

• 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.

  PMID: 29230622 RESULT

• 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.

  PMID: 16688361 RESULT

• 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.

  PMID: 25973022 RESULT

• 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.

  PMID: 18267026 RESULT

• 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.

  PMID: 19140233 RESULT

MeSH Terms

Conditions

Dyspepsia; Heartburn; Bile Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases; Duodenogastric Reflux; Stomach Diseases; Gastrointestinal Diseases

Study Officials

• Amira A Othman, Ph. D

  Zagazig University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 23, 2021
• Study Start: January 1, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)