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

Completed

• Conditions: Heartburn; Dyspepsia; Bile Reflux
• Interventions: Device: upper GIT endescopy

• Registration Number: NCT05131802
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-20
• Study First Posted: 2021-11-23
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postcholecystectomy group	upper GIT endescopy	which included patients that had undergone cholecystectomy.
Biliary intervention group	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.

Primary Outcome Measures

Name	Time	Method
gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.	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.
gastric mucosa histopathological changes 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	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.
intragastric total bilirubin level	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
gastric juice pH	10 minutes for endoscopy for gastric fluid collection	Upper GIT endoscopy is performed and gastric fluid is aspirated to detect gastric juice pH

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Sharkia, Egypt