Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sleeve Gastrectomy

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.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

Inclusion Criteria:

* 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.
* Ability to understand and comply with scheduled follow-up visits.

Exclusion Criteria:

* 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.
* Active cholestatic hepatobiliary disease or treatment with bile acid sequestrants, ursodeoxycholic acid, or medications that significantly alter bile acid metabolism at the time of saliva sampling or within one month before sample collection.
* Acute infection or systemic antibiotic treatment within four weeks before saliva sample collection.
* Pregnancy or breastfeeding.

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