Same-session endoscopic ultrasound (EUS)-endoscopic retrograde cholangiopancreatography (ERCP) and therapeutic EUS (tEUS) are increasingly adopted for diagnosis and management of pancreaticobiliary diseases. While traditionally performed under deep sedation or general anaesthesia, evidence on moderate sedation strategies remains limited. Moreover, moderate sedoanalgesia may represent an opportunity for non-third-level centres lacking anaesthesiology support for endoscopic procedures. We prospectively evaluated the feasibility, safety, and patient-reported outcomes of performing combined EUS-ERCP and tEUS under moderate sedoanalgesia with intravenous midazolam and meperidine.

The PETI-MIDA study is a prospective observational study conducted in a non-third-level hospital between April and November 2025. All consecutive adults undergoing same-session EUS–ERCP or tEUS under moderate sedoanalgesia with midazolam and meperidine were included. Primary outcomes were procedural completion, safety, and patient-reported experience assessed using a validated tool (PROSAS score). Patients and sedation characteristics, clinical parameters, and adverse events (AEs) were collected in a standardized Case Report Form (CRF). A multivariate logistic regression explored any correlation between clinical characteristics and patient-reported outcomes.

In total, 35 patients were enrolled, the median age was 75 years (IQR 63–83), and the median body mass index (BMI) was 26.1 kg/m² (IQR 22.9–30.0). Median Charlson Comorbidity Index was 4 (IQR 2–6), and median ASA score was 2 (IQR 1–3). Indications for endoscopy included choledocholithiasis (65.7%), malignant biliary obstruction (14.3%), and indeterminate biliary stricture (20%). EUS-guided fine-needle biopsy (FNB) was performed in 11 patients (31.4%), biliary stenting in 10 (28.6%), and 3 patients (8.6%) underwent EUS-guided gallbladder drainage (EUS-GBD). Mean midazolam dose administered was 5.6 mg (± 2.1), while meperidine was 64.2 mg (± 13.6). No procedure-related AEs occurred among the cases performed. Most of the patients (88.6%) were adequately cooperative and no procedures were interrupted due to lack of patients’ cooperation. Sedation-related AEs included one (2.9%) oxygen desaturation, two (5.8%) tachycardia and one (2.9%) hypotension, all managed without the need for anaesthesiology support and without leading to an endoscopy interruption. In 29 cases (82.9%), patients reported satisfaction with the sedation level achieved. On a 0–10 numeric scale administered to assess intraprocedural discomfort (0 indicating no pain and 10 indicating severe pain), the median score was 1 (IQR 0–2). In the multivariate analysis, intraprocedural discomfort level was related to BMI (p-value = 0.03).

Moderate sedoanalgesia is an appropriate sedation strategy for same-session EUS–ERCP and tEUS, demonstrating low complication rates and high patient tolerability.