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

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ClinicalTrials.gov Identifier: NCT05131802
Recruitment Status : Completed
First Posted : November 23, 2021
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Amira Ahmed Othman, Zagazig University

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.

Condition or disease Intervention/treatment
Dyspepsia Heartburn Bile Reflux Device: upper GIT endescopy

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 288 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bile Reflux Gastropathy: Prevalence and Risk Factors After Therapeutic Biliary Interventions: A Retrospective Cohort Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 15, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Postcholecystectomy group
which included patients that had undergone cholecystectomy.
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®).

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
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®).




Primary Outcome Measures :
  1. gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae. [ Time Frame: 7 minutes for endoscopy ]
    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.

  2. gastric mucosa histopathological changes 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 ]
    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.

  3. intragastric total bilirubin level [ Time Frame: 10 minutes for endoscopy for gastric fluid collection ]
    Upper GIT endoscopy is performed and gastric fluid is aspirated for quantitative analysis of gastric aspirate total bilirubin level

  4. gastric juice pH [ Time Frame: 10 minutes for endoscopy for gastric fluid collection ]
    Upper GIT endoscopy is performed and gastric fluid is aspirated to detect gastric juice pH



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who were admitted to the university hospitals with inclusion criteria
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131802


Locations
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Egypt
Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44511
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Amira A Othman, Ph. D Zagazig University Hospitals
Publications of Results:
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Responsible Party: Amira Ahmed Othman, Dr., Zagazig University
ClinicalTrials.gov Identifier: NCT05131802    
Other Study ID Numbers: Bile Reflux
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: to keep participant privacy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amira Ahmed Othman, Zagazig University:
Bile Reflux
Cholecystectomy
ERCP
Bilirubin
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Bile Reflux
Dyspepsia
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Biliary Tract Diseases
Duodenogastric Reflux
Stomach Diseases