Introduction

Duodenogastroesophageal reflux (DGER), or bile reflux, has gained renewed interest due to the increasing number of bariatric surgeries (BS) performed. Anatomical modifications after BS may predispose patients to reflux. Revisional bariatric surgery (RBS) is indicated for inadequate weight loss or refractory symptoms.

Aims & Methods

This study aimed to evaluate the diagnostic accuracy of pH-impedance (pH-Z) monitoring in detecting DGER, using spectrophotometric bilirrubin (Bilitec2000) as the clinical reference standard. This prospective study included consecutive patients with a history of sleeve gastrectomy (SG) referred for preoperative evaluation prior to RBS between October 2023 and February 2025. All patients underwent simultaneous 24-hour pH-Z monitoring and Bilitec2000 monitoring while off proton pump inhibitors (PPIs). Patients followed a standardized white semiliquid diet. Gastroesophageal reflux disease (GERD) was diagnosed according to the Lyon 2 Consensus. Pathological bile reflux was defined as a total bilirubin absorbance ≥ 0.14 for ≥ 1.9% of the monitoring time.

Results

Fifty-three patients were enrolled [38 (71.7%) female, median age 48 years (IQR 43 – 55), median BMI 37.3 Kg/m² (IQR 34.1 – 41.3)]. Reason for RBS evaluation included
inadequate weight loss (39.6%) refractory reflux symptoms (32.1%), both (24.5%) and other indications (3.5%). GERD was diagnosed in 31 patients (58.5%) and 21 (39.6%) had pathological bile reflux. Erosive GERD according to Los Angeles classification was identified in 10 patients (19.6%). The area under the curve for non-acid reflux episodes detected by pH-z in diagnosing DGER was 0.61 (CI 95% 0.44 - 0.78), with an optimal cutoff of 85 episodes (sensitivity: 38.1% (CI 95% 20.8 – 59.1); specificity of 93.6% (CI95% 79.9 – 98.3). A moderate correlation was found between non-acid reflux and bile reflux (r = 0.38, p=0.005). However, GERD was not associated with increased bile exposure time (1.4% (IQR 0.3 – 9.5) vs 1.3% (IQR 0.0 – 4.8), p=0.262), nor was this association observed in those with erosive esophagitis (1.9%, IQR 0.4 – 9.5 vs 1.4% IQR 0.0 – 5.8; p=0.914).

Conclusion

Approximate 40% of SG patients undergoing RBS evaluation had pathological bile reflux, which was not linked to GERD or erosive esophagitis. Despite a moderate correlation between bile and non-acid reflux episodes, pH-z monitoring failed to reliably detect DGER and should not be considered a substitute for spectrophotometric bilirrubin concentration monitoring.

References

- Basnayake C, Geeraerts A, Pauwels A, et al. Systematic review: duodenogastroesophageal (biliary) reflux prevalence, symptoms, oesophageal lesions and treatment. Aliment Pharmacol Ther. 2021;54(6):755-778. doi:10.1111/apt.16533.
- Eldredge TA, Bills M, Myers JC, Bartholomeusz D, Kiroff GK, Shenfine J. HIDA and Seek: Challenges of Scintigraphy to Diagnose Bile Reflux Post-Bariatric Surgery. Obes Surg. 2020;30(5):2038-2045. doi:10.1007/s11695-020-04510-7

Introduction

Sedation is integral to gastrointestinal (GI) endoscopy to enhance procedural tolerance and efficiency [1]. Traditional agents like midazolam and propofol, while effective, present limitations related to recovery time, safety, and need for anesthesiologist supervision. Remimazolam, a novel benzodiazepine with rapid onset and offset, may enable effective non-anesthesiologist-administered sedation (NAAS) in routine endoscopy [2].

Aims & Methods

A prospective, multicenter, real-world study was conducted between November 2024 and March 2025. Adult patients undergoing elective upper or lower gastrointestinal (GI) endoscopy under procedural sedation-analgesia (PSA) without the presence of an anesthesiologist were enrolled. Inclusion criteria were: age ≥18 years, American Society of Anesthesiologists (ASA) physical status I–III, and a body mass index (BMI) between 18 and 51 kg/m². Exclusion criteria included: known allergy to anesthetic drugs or a history of anesthesia-related adverse reactions; glucose-6-phosphate dehydrogenase deficiency; severe respiratory disease; and pregnancy. All patients undergoing emergency or urgent GI endoscopy were excluded.The primary outcomes were the sedative efficacy and safety of remimazolam during endoscopy. Efficacy was defined as successful completion of the procedure without interruption due to inadequate sedation. Adverse events (AEs) were recorded and classified by severity (major or minor) and type (e.g., hypotension, hypoxia, bradycardia, nausea, vomiting, and injection site pain). Remimazolam was administered by trained endoscopists: induction was achieved with 5–7 mg intravenously, titrated based on individual risk factors, with 2.5 mg supplemental doses as needed (maximum cumulative dose: 33 mg).

Results

A total of 182 patients (EGD n=75; colonoscopy n=112) were included. Procedure completion was achieved in 175 cases (96.3%), with success rates of 97.3% for EGD and 95.5% for colonoscopy. All sedation failures (n=7) were attributed to inadequate sedation and not to ASA class. No serious AEs were reported. Minor AEs included hypotension (n=4), bradycardia (n=1), nausea (n=1), vomiting (n=4), and hiccups (n=1), all managed conservatively. Median cumulative remimazolam doses were 10.9 mg (colonoscopy) and 10.0 mg (EGD), with median recovery times of 6.25 and 5.9 minutes, respectively. No patients required flumazenil or rescue sedation. Among obese patients (BMI >40), remimazolam was both effective and safe.

Conclusion

Remimazolam provides a highly effective and safe sedation alternative for GI endoscopy in real-world NAAS settings, ensuring rapid recovery and minimal AEs, even in patients with elevated ASA status or obesity. This study was prospective real-world and had several limitations. First the number of patients was too small to accurately assess rare adverse events. Further randomized controlled trials with larger populations are recommended to confirm these results.

References

1. Lin OS. Sedation for routine gastrointestinal endoscopic procedures: a review on efficacy, safety, efficiency, cost and satisfaction. Intest Res 2017;15:456-66. doi: 10.5217/ir.2017.15.4.456.
2. Hu Q, Liu X, Wen C, et al. Remimazolam: an updated review of a new sedative and anaesthetic. Drug Des Devel Ther 2022;16:3957-74. doi: 10.2147/DDDT.S384155.

Introduction

STW 5, a herbal medicinal product with well characterized pharmacological action, has been shown in several RTCs to be an effective treatment in disorders of the gut-brain interaction (DGBI) as functional dyspepsia (FD) [1, 2]. The aim of the present study was to examine whether changes in gut microbiota induced in an experimental model of FD could be prevented by STW 5.

Aims & Methods

FD was induced in rats by subjecting them to neonatal maternal separation followed by subjecting them to restraint stress for 90 minutes/day for one week. During that week, one group (8 animals) was treated with the liquid form of STW 5 (5 ml/Kg) and one with its vehicle at the same dose level. Animals were sacrificed 24 h after the last drug administration. Fecal samples were taken from the cecum. Genomic DNA was isolated and changes in selected bacterial phyla and genera were assessed using quantitative Real Time-PCR (qPCR). The main phyla studied under the influence of stress in the model were the Bacteroidetes, Firmicutes, Fusibacterium and Actinobacteria.

Results

FD led to a 50% drop in the Lactobacilli population but to a two-fold rise in Proteobacteria abundance but did not affect significantly the changes in Bacteroidetes. Furthermore, the Methanobrevibacter population was raised more than two-fold while the genomic DNA concentration in Bifidobacterium dropped from ca. 3 ng/g feces to nearly nil.

Conclusion

In general, STW 5 tended to ameliorate and protect against the changes induced by the stress model. The results lend further support to the use of STW 5 in FD and IBS by providing evidence that it acts at least in part through influencing beneficially the changes in intestinal microbiota induced by stress. Taken together, the findings shed more light on mechanisms involved in the therapeutic action of STW 5 in gastro-intestinal disorders.

References

1. Malfertheiner P. STW 5 (Iberogast) Therapy in Gastrointestinal Functional Disorders. Dig Dis. 2017, 35 Suppl 1: 25-29
2. Allescher H-D, Burgell R, Malfertheiner P, Mearin F. Multi-target Treatment for Irritable Bowel Syndrome with STW 5: Pharmacological Modes of Action. Gastrointest Liver Dis. 2020;29: 227-233

Disclosure

OK and HA-K are empolyees of Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany. MTK has been obtaining travel support and speakers fees from Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany.