The goal of this observational study is to learn whether bile acids and pepsin in saliva can help identify adults at higher risk of developing reflux-related esophageal disease after sleeve gastrectomy, including Los Angeles grade B-D erosive esophagitis and Barrett's esophagus. The study will include adults undergoing sleeve gastrectomy as part of their regular clinical care. Participants will be evaluated before and after surgery and will serve as their own comparison group over time.
The main questions it aims to answer are:
Are saliva bile acids and pepsin linked to Los Angeles grade B-D erosive esophagitis or Barrett's esophagus after sleeve gastrectomy? How do saliva bile acids and pepsin change before and after sleeve gastrectomy? Can saliva bile acids and pepsin become useful biomarkers for detecting reflux-related esophageal disease after sleeve gastrectomy? Are saliva biomarker levels linked to reflux symptoms and endoscopy results after surgery?
Researchers will compare saliva biomarker levels before and after surgery and between participants with and without reflux-related esophageal disease.
Participants will:
Provide saliva samples before surgery and at 12 and 36 months after surgery Provide fasting and post-meal saliva samples Undergo routine postoperative clinical follow-up and upper gastrointestinal endoscopy Complete reflux symptom questionnaires during follow-up
The study will also explore whether saliva biomarkers could help select participants for follow-up endoscopy after sleeve gastrectomy.
Adults aged 18 years or older undergoing sleeve gastrectomy at a participating center.
Indication for obesity treatment with sleeve gastrectomy according to the 2022 ASMBS-IFSO consensus criteria, with a maximum body mass index (BMI) of 50 kg/m².
Approved for sleeve gastrectomy by the obesity multidisciplinary committee.
Ability and willingness to provide informed consent for biological sample collection and analysis.
According to Lyon 2.0 criteria, participants with previous evidence of conclusive reflux disease, including Los Angeles grade B, C, or D esophagitis, peptic stricture, or Barrett's esophagus diagnosed before surgery.
Bariatric procedures other than sleeve gastrectomy, including Roux-en-Y gastric bypass or revisional bariatric surgery.
History of other preexisting esophageal diseases.
Previous esophageal surgery.
Adults with severe obesity undergoing primary sleeve gastrectomy as part of routine clinical care at participating bariatric centers, without previous conclusive reflux-related esophageal disease on preoperative upper gastrointestinal endoscopy. Participants will be prospectively evaluated before and after surgery with saliva biomarker analysis, reflux symptom assessment, and routine postoperative endoscopic follow-up.
Case-control
Prospective
Not listed
Association between salivary bile acid and pepsin concentrations and reflux-related esophageal disease after sleeve gastrectomy
Association between total and specific salivary bile acid concentrations as well as pepsin and the presence of Los Angeles grade B-D erosive esophagitis and/or Barrett's esophagus detected on upper gastrointestinal endoscopy.
Total salivary bile acid concentration before and after sleeve gastrectomy
Total salivary bile acid and pepsin concentrations measured in fasting and 1-hour post-meal saliva samples, recorded as continuous quantitative variables.
Profile of individual salivary bile acids and pepsin before and after sleeve gastrectomy
Concentration of individual salivary bile acids and pepsin measured in fasting and 1-hour post-meal saliva samples.
Endoscopic reflux-related esophageal disease after sleeve gastrectomy
Presence of Los Angeles grade B-D erosive esophagitis and/or Barrett's esophagus on upper gastrointestinal endoscopy.
Severity of gastroesophageal reflux symptoms after sleeve gastrectomy
Presence and severity of gastroesophageal reflux symptoms assessed using reflux questionnaires.
Association between salivary bile acid and pepsin concentrations and reflux symptoms
Association between total and specific salivary bile acid and pepsin concentrations and gastroesophageal reflux symptom severity assessed using reflux questionnaires.
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