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Peroralcholangio-pancreatoscopy (POCP) is used for diagnosis and treatment of biliopancreatic disease when standard endoscopy (ERCP) or pre-operative imaging workup failed. We aimed to evaluate the diagnostic and therapeutic performance of POCP in complex biliary and pancreatic diseases. Patients with indeterminate biliary or pancreatic duct (PD) strictures, and patients with failure of complex biliary or pancreatic stones removal, were enrolled (six centers). The primary endpoint evaluated malignancy diagnostic performances (accuracy, sensitivity, specificity) and therapeutic performances (biliary or pancreatic stones extraction). Secondary endpoints evaluated: technical success in lesion visualization, ease of maneuvering, image quality and 30-days complications. From November 2016 to March 2018, 66 patients were included: 29/37 women/men, median age (IQR): 73 (64–82). Fifty-three patients had diagnostic POCP and 13 patients therapeutic POCP. One endoscopist with one or two endoscopy nurses performed 94% of the POCP. The 'POCP visual impression' of malignancy showed 92.0% sensitivity, 92.9 % specificity and 92.5 % overall accuracy compared with the final diagnosis. 'POCP-guided samples histological analysis' showed 75.0 % sensitivity and 91.6% specificity. The technical success for lesion visualization was 98.5%. The median VAS scores for insertions in bile and PD were respectively 9.0 (8.1–9.6) and 9.0 (8.8–10.0). Median VAS score for access to the lesion and image quality were respectively 9.0 (7.7–9.6) and 9.0 (7.9–9.7). Only three 30-day minor complications occurred without any major complications. POCP was an effective, safe and easy-to-use tool in routine clinical practice for the management of complex diagnostic and therapeutic biliary and pancreatic diseases (NCT03190343). [ABSTRACT FROM AUTHOR]

Current 2-D ultrasound technology is unable to perform a midline neuraxial needle insertion under real-time ultrasound guidance using a standard needle and without an assistant. The aim of the work described here was to determine the feasibility of a new technology providing such capability, starting with a study evaluating the selected puncture site. A novel 3-D ultrasound imaging technique was designed using thick-slice rendering in conjunction with a custom needle guide (3DUS + Epiguide). A clinical feasibility study evaluated the ability of 3DUS + Epiguide to identify the epidural needle puncture site for a midline insertion in the lumbar spine. We hypothesized that (i) the puncture site identified by 3DUS + Epiguide was within a 5-mm radius from the site chosen by standard palpation, and (ii) the difference between the two puncture sites was not correlated to the patient characteristics age, weight, height, body mass index and gestational age. The mean (±standard deviation) distances between puncture sites determined by 3DUS + Epiguide and palpation were 3.1 (±1.7) mm and 2.8 (±1.3) mm, for the L2-3 and L3-4 interspaces of 20 patients, respectively. Distances were comparable to intra-observer variability, indicating the potential for a thick-slice rendering of 3-D ultrasound along the Epiguide trajectory to select the puncture site of a midline neuraxial needle insertion. The long-term potential benefits of this system include increased efficiency and use of anesthesia, and a reduction in the frequency and severity of the complications from incorrect needle insertions. Epidural success in the most difficult cases (e.g., the obese) will be the focus of future work. [ABSTRACT FROM AUTHOR]