Endosonography for right-sided and acute upper intestinal misery: The EFRAIM study: A prospective, randomized, controlled, blinded study

Background: Acute upper abdominal pain is a frequent symptom leading to hospital admission. Objective: To determine whether a primary intra- and extraluminal diagnostic approach enabled by endoscopic ultrasound is as effective as a conventional diagnostic algorithm of transabdominal ultrasound followed by oesophagogastroduodenoscopy. Methods: A total of 240 patients who presented with acute right-sided and/or upper abdominal pain were prospectively recruited. Exclusion criteria were chronic pain, malignancy, prior abdominal surgery, bleeding, peritonitis, and elevated liver enzymes or lipase as defined 3-times higher than upper reference value. All patients underwent first transabdominal ultrasound and were then randomized (1 : 1) to either endoscopy followed by endoscopic ultrasound or vice versa. Patients and respective examiners were blinded to prior findings. Results: A total of 223 patients were included. Endoscopic ultrasound provided a higher diagnostic yield than the combination of transabdominal ultrasound and endoscopy (62.3 vs. 50.7%; p = 0.001). For mucosal/intraluminal lesions, we observed a very good agreement between both endoscopic modalities (kappa 0.89). The agreement for pancreatic and biliary causes was good between both ultrasound modalities (kappa 0.66). Conclusions: Due to its high diagnostic yield, endoscopic ultrasound as a primary diagnostic modality appears to be a valuable option in patients with acute upper abdominal pain.