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Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been specifically designed for collecting sufficient tissue specimens, clinical studies have indicated no clear difference in diagnostic performance between these novel needles and conventional puncture needles. Recently, a needle with Franseen geometry was developed specifically for EUS-FNA biopsy. Due to the characteristic shape of its tip, the Franseen needle is expected to be effective for scraping tissues, thus potentially increasing the diagnostic accuracy of EUS-FNA biopsy. We plan to carry out a prospective, multicenter, open-labeled, controlled trial to compare conventional and Franseen needles in terms of the diagnostic accuracy of EUS-FNA for evaluating the malignancy of pancreatic mass lesions. Methods/design The study will enroll 520 patients with pancreatic mass managed at any of 21 participating endoscopic centers. Lesion samples obtained using 22G conventional and Franseen needles will be assessed to compare the efficacy and safety of these two types of needles in EUS-FNA for evaluating the malignancy of mass lesions in the pancreas. Tissue samples will be fixed in formalin and processed for histologic evaluation. For the purpose of this study, only samples obtained with the first needle pass will be used for comparing the: (i) accuracy of the malignancy diagnosis, (ii) sensitivity and specificity for the malignancy diagnosis, (iii) procedure completion rate, (iv) sample cellularity, and (v) incidence of complications. Discussion The outcomes of this study may provide insight into the optimal needle choice for evaluating the malignancy of pancreatic solid lesions, thus aiding in the development of practice guidelines for pancreatic diseases.

Pancreatic duct stenting is a feasible technique for the treatment of symptomatic pancreatic duct obstruction. However, pancreatic obstruction because of impaction of large pancreatic duct stones makes the insertion of various devices, including plastic stents, challenging. Recently, a novel stent delivery system with a dilation function (EndoSheather; Piolax Medical Devices, Kanagawa, Japan) has become available in Japan. The diameter of the outer sheath of this device is 7.2Fr, and that of the inner sheath is 5.9Fr. In addition, the tip of this device is extremely tapered (3.9Fr), conforming to a 0.035-inch guidewire. These characteristics allow for easier penetration of the stricture site, and after removal of the inner sheath, various devices less than 5.9Fr in size can be inserted. A recently available small-caliber plastic stent (5Fr, Through & Pass Type IT; Gadelius Medical, Tokyo, Japan) can also be inserted within this outer sheath. We herein describe technical tips for a novel pancreatic duct stent technique using the EndoSheather, which is called the "Molting technique" (a). A 49-year-old man was admitted to our hospital to be treated for frequent pancreatitis because of impaction of a large pancreatic duct stone, for which endoscopic retrograde cholangiopancreatography was attempted. Although a 0.025-inch guidewire was successfully advanced into the main pancreatic duct across the pancreatic stone, several devices, including a Soehendra stent retriever, could not be inserted. Therefore, EndoSheather insertion was attempted. Although this device was successfully inserted, the tip of the device barely passed through the site of obstruction. Subsequently, the inner sheath of the EndoSheather was removed, and a small-caliber plastic stent was inserted into the outer sheath. Finally, we removed the outer sheath and retained the plastic stent (b). He discharged without any adverse events and also underwent contentious stent exchange. The presented technique might be useful for pancreatic duct stenting in challenging cases. Watch the Video, Supplementary Digital Content 1, http://links.lww.com/AJG/C469.

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