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66 Creation of a Choledochoduodenostomy Using a Novel Lumenal Apposition Device: First Clinical Experience Takao Itoi*, Kenneth Binmoeller, Fumihide Itokawa, Atsushi Sofuni, Toshio Kurihara, Takayoshi Tsuchiya, Kentaro Ishii, Shujiro Tsuji, Nobuhito Ikeuchi, Fuminori Moriyasu Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan; Interventional Endoscopy Services, California Pacific Medical Center, California, CA Introduction: Recently we reported on the feasibility and safety of transenteric drainage of pancreatic pseudocysts and gallbladders using a newly developed lumenal apposition device (GIE 2012). We now report on the first clinical experience of creation of a transenteric choledochoduodenostomy using the Lumenal Apposition Device (LAD). Aim: To evaluate the feasibility and, safety of transenteric biliary drainage using the LAD for palliation of obstructive jaundice. Materials: The LAD consists of braided nitinol heat-set into a dual flange configuration. Fully expanded, the stent diameter and length measure 6 mm and 8 mm, respectively. The flange diameter is 14 mm. The LAD is constrained within a 10 Fr delivery catheter. Patients and Methods: In 8 patients (3 male, mean age 61.1, range 62-99) with distal biliary obstruction and jaundice due to 4 pancreatic cancers, 3 ampullary cancers, and 1 distal bile duct cancer, the LAD was placed using a 3.7 mm channel curved array echoendoscope (Olympus). The bile duct was punctured with a 19G FNA needle under endoscopic ultrasound (EUS) guidance and a guidewire inserted. The fistula tract was primed for LAD placement with a bougie catheter and/or cautery needle and/or 4 mm non-compliant balloon. The LAD was deployed under combined EUS and endoscopic guidance. After deployment, the LAD lumen was dilated with a noncompliant balloon catheter to 6 mm to optimize drainage when indicated. Nasobiliary catheters were placed across the LAD for irrigation at the discretion of the endoscopist. Results: All LADs were safely placed without acute complications, including bleeding or perforation. The LAD did not migrate, dislodge or otherwise change position after deployment. Four patients had self-limited abdominal pain after the procedure with mild elevation of the white cell count. Acute cholecystitis occurred in one patient, who proceeded to percutaneous transhepatic gallbladder drainage. The percutaneous drain was removed one month later. In all cases, translumenal biliary drainage via the anastomosis created by the LAD resulted in palliation of obstructive jaundice with improved liver enzymes and bilirubin. Conclusion: EUS-guided deployment of the LAD is feasible and safe for translumenal bile duct drainage and provides effective palliation of obstructive jaundice.

Safety and Effectiveness of Endoscopic Sphincterotmy Plus Large Balloon Dilation: Single Center Mid-Term Outcome Fumihide Itokawa*, Takao Itoi, Atsushi Sofuni, Takayoshi Tsuchiya, Nobuhito Ikeuchi, Reina Tanaka Tokyo Medical University, Tokyo, Japan Background: Endoscopic sphincterotmy plus large balloon dilation (ESLBD) would theoretically favorable for extracting large bile duct stones. Although there are many studies on the feasibility and short-term outcome, there is no midto long-term outcome after ESLBD. The aim of our study is to evaluate the mid-term outcome of ESLBD. Methods: 168 patients with large bile duct stones who underwent ESLBD from November 2006 through December 2011 were retrospectively reviewed. The patients were observed till November 2012. In the present study, inclusion criteria were used to select patients with large and/or multiple bile-duct stones: 1) bile duct stone, 13 mm or more in shortest dimensionor 2) multiple ( 3) bile-duct stones, with the smallest more than 10 mm in shortest dimension. Exclusion criteria included coagulopathy, marked thrombocytopenia, anticoagulation therapy, acute pancreatitis, septic shock. After endoscopic sphincterotomy or prior sphincterotomy, the papillary balloon catheter (maximum diameter 15 mm, 18 mm, or 20 mm) was passed over the guidewire and positioned across the main duodenal papilla. The size of balloon was matched to the diameters of the bile duct and the stones. Results: The patients mean age were 76.8 9.8years. The history of gastric operation was 140 with none (normal), 2 with Billroth 1, 11 with Billroth 2 and 15 with Rouxen Y. 70 patients (41.7%) had periampullary diverticulum. The presence of Gallstone was 65 (38.7%), the history of cholecystectomy was 42(25%), the previous sphincterotomy was 33 (19.6%). The mean follow up period were 39.85 13.7 months (range 11-69). 7 patients (4.2%) occurred stone recurrence (Mean age 72.8 7.8, surgically altered anatomy: none 6, Billroth 2 1, Gallstone 3, Periampullary diverticulum 1, History of sphincterotomy 6 (85.7%), History of stone recurrence 6 (85.7%)). There were no recurrence who had first ESLBD treatment. Conclusions: ESLBD can be safely and effectively performed. Furthermore, our mid-term outcome revealed that ESLBD is low risk of recurrence of bile duct stones. Thus, although further lon-term outcome seems to be mandatory, it will be promising treatment in patients with difficult bile duct stones.

Background Intraductal papillary mucinous neoplasms (IPMN) of the pancreas are associated with substantially increased risk of malignant transformation when compared to other types of pancreatic lesions such as serous cystadenoma (SCA) and mucinous cystadenoma (MCA). A recent study suggests that detection of a mutation in codon 201 of GNAS in pancreatic cyst fluid DNA may be able to distinguish IPMN from other lesions of the pancreas, including both MCA and SCA [1]. This study found the detection of a GNAS mutation to be 100% specific, and the presence of either a GNAS or KRAS mutation to be 96% sensitive for IPMN. We examined the diagnostic significance of GNAS mutations in a cohort of pancreatic cyst fluid specimens and correlated the results with the associated diagnostic information. Methods 200 residual pancreatic cyst fluid DNA specimens from 198 distinct patients were retrieved from specimen archives and tested. These specimens were chosen so that there was an equal mix of KRAS mutated and wildtype results, and a range of CEA results above and below 192 ng/mL. DNA was amplified with primers targeting the codon 201 region, and sequenced using capillary electrophoresis and Sanger sequencing. The clonality of the mutation was identified as the ratio of mutant to wildtype, with a limit of detection of 10%. IPMN was determined to be present if there was duct dilation or connectivity to the duct system together with observation of mucinous characteristics of the fluid (e.g. gross mucin, mucin stain, elevated CEA, etc.). Results GNAS mutations were found in 50/200 (25%) specimens. A significant association between the presence of KRAS mutation and GNAS mutation was found, with more GNAS mutations present among KRAS-mutated than KRASwildtype cysts (odds ratio=4, p=7.0e-5). There was no significant difference in mean CEA values between according to GNAS mutation status. Two small ( CAT) that has not been previously reported in IPMN; this mutation was present in only that one specimen. In 20/50 (40%) of GNAS mutated-specimens neither duct dilation nor cyst communication with the duct system was observed. Conclusions Based on the present evaluation, GNAS is found to be mutated in a significant number of cases lacking the classic features of IPMNs. Further work is needed to better understand the role of GNAS in discriminating IPMNs from other cystic neoplasms of the pancreas and in evaluating the malignant potential of either; additional surgical outcomes would be valuable for this assessment. 1. Sci. Transl. Med. 3, 92ra66 (2011).

Endoscopic biliary stenting for malignant biliary obstruction is currently the gold standard for biliary drainage. Biliary cancer treatment is crucial. Cases of gastric outlet obstruction that includes the duodenum because of cancer invasion and biliary obstruction are seldom observed. The required treatment for such cases is simple biliary stenting and a different treatment for duodenal obstruction. Hence, double stenting for bile duct and duodenal obstruction has drawn attention. In the present review, we state different treatment strategies for malignant duodenal obstruction and then describe double stenting in biliary obstruction that also includes non-biliary cancer malignant lesions and duodenal obstruction.

AIM: To examine the coexistence of metachronous and synchronous cancer in branch duct intraductal papillary mucinous neoplasms of the pancreas (IPMN). METHODS: We reviewed the records of 145 patients with branch duct IPMN between January 1991 and April 2008 and assessed the relationship between IPMN and intra- or extra-pancreatic carcinoma and the outcome of IPMN. RESULTS: The mean observation period was 55.9 ± 45.3 mo. Among the 145 patients, the frequency of extra-pancreatic cancer was 29.0%. The frequency of gastric cancer, colon cancer, breast cancer, and pancreatic cancer were 25.5%, 15.7%, 13.7%, and 9.8%, respectively. Twenty (13.8%) of the patients died. The cause of death was extra-pancreatic carcinoma in 40%, pancreatic cancer in 25%, IPMN per se in 20%, and benign disease in 15% of the patients. CONCLUSION: The prognosis for IPMN depends not on the IPMN per se, but on the presence of intra- or extra-pancreatic cancer.

症例は70歳代，女性．発熱，上腹部痛，全身倦怠感を主訴に来院．腹部超音波，腹部CT上，膵頭部に境界明瞭で辺縁整の造影効果の乏しい径90mm大の腫瘤を認め，肝内にも造影効果の乏しい30mm大の腫瘤を認めた．超音波内視鏡下穿刺吸引生検（EUS-FNA）を行いdiffuse large B cell lymphomaと診断し化学療法を開始した．治療開始後3ヶ月の腹部CTでは完全寛解（CR）が得られ，2年以上経過した現在も再発は認めていない．EUS-FNAにより確定診断を得た悪性リンパ腫の症例報告は少なく，適切な治療方針の決定にて，完全寛解に至り良好な経過を辿った症例であったため報告する．

Endoscopic ultrasonography (EUS)-guided biliary drainage was performed for treatment of patients who have obstructive jaundice in cases of failed endoscopic retrograde cholangiopancreatography (ERCP). In the present study, we introduced the feasibility and outcome of EUS-guided choledochoduodenostomy in four patients who failed in ERCP. We performed the procedure in 2 papilla of Vater, including one resectable case, and 2 cases of cancer of the head of pancreas. Using a curved linear array echoendoscope, a 19 G needle or a needle knife was punctured transduodenally into the bile duct under EUS visualization. Using a biliary catheter for dilation, or papillary balloon dilator, a 7-Fr plastic stent was inserted through the choledochoduodenostomy site into the extrahepatic bile duct. In 3 (75%) of 4 cases, an indwelling plastic stent was placed, and in one case in which the stent could not be advanced into the bile duct, a naso-biliary drainage tube was placed instead. In all cases, the obstructive jaundice rapidly improved after the procedure. Focal peritonitis and bleeding not requiring blood transfusion was seen in one case. In this case, pancreatoduodenectomy was performed and the surgical findings revealed severe adhesion around the choledochoduodenostomy site. Although further studies and development of devices are mandatory, EUS-guided choledochoduodenostomy appears to be an effective alternative to ERCP in selected cases.

We encountered a 65-year-old man with a carcinoid tumor of the minor duodenal papilla. Since he had liver cirrhosis and completely refused surgery, we performed an endoscopic snare papillectomy. The papillectomy was performed successfully without procedure-related complication. The specimens revealed a carcinoid tumor showing that the margin of the tumor was positive. One week later, upper GI endoscopy was performed and the biopsy specimens obtained from base of ulcer showed no neoplastic cells. We performed a duodenoscopy and CT 3, 6 and 18 mo later, and there was no macroscopic or microscopic evidence of tumor recurrence after more than 4 years.

Assessment of Occult Pancreatobiliary Reflux by Biliary Amylase Levels in Patients with Pancreaticobiliary Disease Takao Itoi, Kazuto Nakamura, Atsushi Sofuni, Fumihide Itokawa, Kazuhiro Kakimi, Jun Sanada, Fuminori Moriyasu Objectives: Pancreatobiliary maljunction (PBM) is a high risk factor for biliary tract cancer. Carcinogenesis by PBMhas yet to be completely clarified; however, it has been suggested that the mixing of pancreatic juice and bile could activate pancreatic enzymes. Recently, however, several investigators reported existence of pancreatobiliary reflux in patients with a normal pancreaticobiliary junction. The aim of this study was to prospectively examine pancreatobiliary reflux in patients with a normal pancreaticobiliary junction by measuring the amylase level in bile obtained during ERCP. Methods: Eligible patients included 86 consecutive cases of pancreaticobiliary disease with prospective implementation of bile collection during an ERCP procedure. Patients with PBM were excluded. Nineteen cases of eligible patients had simultaneous collection of gallbladder bile. Bile was further collected by cholecystectomy in eight cases. Results: Twenty-two cases (26%) revealed a common bile duct higher than serum amylase (high bile amylase level HBA group) and sixty-six cases exhibited a common bile duct amylase level lower than serum (LBA group). The mean values of common bile duct amylase level in the HBA and LBA groups were 5,502 IU/L and 29 IU/L, respectively. The rate of HBA was significantly higher in patients who were elderly, had a dilated common bile duct, and with choledocholithiasis (p