Clinical trial NCT05131802: Bile Reflux Gastropathy: Prevalence and Risk Factors After Therapeutic Biliary Interventions
Official title: Bile Reflux Gastropathy: Prevalence and Risk Factors After Therapeutic Biliary Interventions: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspepsia
Heartburn
Bile Reflux
Keywords: Bile Reflux
Cholecystectomy
ERCP
Bilirubin
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 288
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were admitted to the university hospitals with inclusion criteria

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.

Eligibility 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.

Primary outcomes:
measure: gastric mucosa endoscopic changes as erythema, bile existence in the stomach, gastric folds thickening, erosions, and petechiae.
timeFrame: 7 minutes for endoscopy
measure: gastric mucosa histopathological changes as chronic inflammation, foveolar hyperplasia , chronic Atrophic gastritis, bile stasis, interstitial inflammation, edema, intestinal metaplasia, and acute inflammation.
timeFrame: 7 minutes for endoscopy for biopsy taken
measure: intragastric total bilirubin level
timeFrame: 10 minutes for endoscopy for gastric fluid collection
measure: gastric juice pH
timeFrame: 10 minutes for endoscopy for gastric fluid collection
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharkia
Study officials:
affiliation: Zagazig University Hospitals
name: Amira A Othman, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.