FOLFIRINOX (FX) and gemcitabine (GEM) plus nab-paclitaxel (GnP) have been reported as effective regimens for unresectable advanced pancreatic cancer (APC). FX may be more effective but is also associated with more adverse events (AEs). Therefore, first-line treatment with FX followed by second-line GnP may be appropriate. Aims: To assess the safety and efficacy of second-line GnP for patients with APC after first-line FX failure. Methods: This study was a multicenter prospective phase II study evaluating second-line GnP in patients with APC after failed first-line FX. The primary endpoint was response rate (RR), and the secondary endpoints were overall survival (OS), progression free survival (PFS), and the frequency and degree of adverse events (AEs). Results: Thirty patients (14 male; median age, 64 years) were enrolled. The RR was 13.3%, with a median follow-up time of 9.3 months. The median OS and PFS were 7.6 and 3.8 months, respectively. From the beginning of first-line treatment, the median OS and PFS were 14.2 and 9.3 months, respectively. Grade 3 or 4 AEs were seen in 70% of patients. Conclusion: Second-line GnP after FX failure for patients with APC could be more effective than GEM alone. Further comparison studies are warranted.

Sarcopenia, defined as decrease in skeletal muscle mass (SMM) and strength, might be associated with reduced survival. We investigated the impact of sarcopenia and decrease in SMM in patients with advanced pancreatic cancer during FOLFIRINOX (FX). Consecutive 69 patients who received FX were evaluated. Skeletal muscle index (SMI) (cm2/m2) was used to evaluate SMM. The cut-off value of sarcopenia was defined as SMI<42 for males and <38 for females, based on the Asian Working Group for sarcopenia criteria. Sarcopenia was diagnosed in 33 (48%) subjects. Comparison of baseline characteristics of the 2 groups (sarcopenia group: non-sarcopenia group) showed a significant difference in sex, tumor size and BMI. There was no significant difference in the incidence of adverse events with grades 3-5 and progression free survival (PFS) of FX between the 2 groups (PFS; 8.1 and 8.8 months; p=0.88). On the multivariate analysis, progressive disease at the first follow-up CT (HR 3.87, 95% CI 1.53-9.67), decreased SMI≧7.9% in 2 months (HR 4.02, 95%CI 1.87-8.97) and CEA ≥4.6 (HR 2.52, 95% CI 1.10-6.11) were significant risk factors associated with poor overall survival (OS), but sarcopenia at diagnosis was not. OS in patients with decreased SMI of ≧7.9% and <7.9 % were 10.9 and 21.0 months (p <0.01), respectively. In conclusion, decrease in SMM within 2 months after the initiation of chemotherapy had significantly shorter OS, although sarcopenia at diagnosis did not affect OS. Therefore, it might be important to maintain SMM during chemotherapy for a better prognosis.

Background Bilateral self-expandable metallic stent (SEMS) placement is effective for long-term management of unresectable malignant hilar biliary obstruction (UMHBO). However, endoscopic reintervention (ERI) for bilateral SEMSs is not well-studied. This study aimed to evaluate ERI efficacy after stent-in-stent placement. Methods Data of 31 patients who underwent ERI from May 2000 to July 2018 were analyzed. Results The technical success rate was 80.7% (25/31) and no adverse events occurred. The functional success rate was 100% (25/25). In a multivariate logistic regression analysis, the angle between the bilateral SEMSs (ABBS) >104°( odds ratio 50.49, 95% CI 3.370-2131, P = 0.0039) and overgrowth (odds ratio 25.70, 95% CI 1.121-1234, P = 0.0423) were risk factors for ERI failure. Multiple liver metastases, which sometimes cause overgrowth, were also risk factors. After ERI, some patients underwent additional SEMS (n = 4), plastic stent (n = 14) placement, or internal cleaning of the initial SEMS alone (n = 7). There were no significant intergroup differences in the 50% time to recurrent biliary obstruction.Conclusions ABBS >104°and overgrowth were risk factors for ERI failure after stent-in-stent placement. In the decisionmaking process for initial SEMS placement for UMHBO, patient condition should be considered, including the angle between bilateral bile ducts and multiple liver metastases.

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Background/Purpose: Unresectable distal malignant biliary obstruction (DMBO) in patients with surgically altered anatomy is traditionally managed with percutaneous transhepatic biliary drainage (PTBD) and stenting because the anatomical features complicate the endoscopic approach to the biliary orifice. EUS-guided approaches recently emerged as alternative treatments; however, limited data comparing the procedures are available. The aim of this study was to compare EUS-antegrade biliary stenting (ABS) with PTBD for DMBO in patients with surgically altered anatomy. Methods: The medical records of patients who underwent EUS-ABS or PTBD for the management of DMBO and had a history of upper intestinal surgery at two tertiary centers between 2007 and 2019 were retrospectively evaluated. The study outcomes were technical, clinical, and internalization success rates and adverse event rates. Results: Of the 64 enrolled patients, 35 underwent EUS-ABS and 29 had PTBD. Basic characteristics including age, sex, performance status, primary malignancy, and reconstruction method did not differ significantly between groups. The technical, clinical, and internalization success rates in the EUS-ABS and PTBD groups were 97.1% vs 96.6% (P = 1.00), 97.1% vs 93.1% (P = .586), and 97.1% vs 75.9% (P = .01), respectively. The adverse event rate was 11.4% vs 27.6% (P = .119). No significant long-term difference was seen in time to recurrent biliary obstruction and survival. Multivariate analysis confirmed EUS-ABS was not an independent risk factor for survival. Conclusions: Similar to PTBD, EUS-ABS can effectively and safely manage DMBO in patients with surgically altered anatomy. Further well-designed trials are warranted to confirm these findings. K E Y W O R D S antegrade technique, ERCP, EUS-AG, EUS-BD, EUS-guided biliary drainage | 969 IWASHITA eT Al. How to cite this article: Iwashita T, Uemura S, Mita N, et al. Endoscopic ultrasound guided-antegrade biliary stenting vs percutaneous transhepatic biliary stenting for unresectable distal malignant biliary obstruction in patients with surgically altered anatomy.

Background: Contrast-enhanced endoscopic ultrasound (CE-EUS) is useful for the differentiation of pancreatic tumors. Using deep learning for the segmentation and classification of pancreatic tumors might further improve the diagnostic capability of CE-EUS. Aims: The aim of this study was to evaluate the capability of deep learning for the automatic segmentation of pancreatic tumors on CE-EUS video images and possible factors affecting the automatic segmentation. Methods: This retrospective study included 100 patients who underwent CE-EUS for pancreatic tumors. The CE-EUS video images were converted from the originals to 90-second segments with six frames per second. Manual segmentation of pancreatic tumors from B-mode images was performed as ground truth. Automatic segmentation was performed using U-Net with 100 epochs and was evaluated with 4-fold cross-validation. The degree of respiratory movement (RM) and tumor boundary (TB) were divided into 3-degree intervals in each patient and evaluated as possible factors affecting the segmentation. The concordance rate was calculated using the intersection over union (IoU). Results: The median IoU of all cases was 0.77. The median IoUs in TB-1 (clear around), TB-2, and TB-3 (unclear more than half) were 0.80, 0.76, and 0.69, respectively. The IoU for TB-1 was significantly higher than that of TB-3 (p < 0.01). However, there was no significant difference between the degrees of RM. Conclusion: Automatic segmentation of pancreatic tumors using U-Net on CE-EUS video images showed a decent concordance rate. The concordance rate was lowered by an unclear TB but was not affected by RM.

EUS-guided rendezvous technique (EUS-RV) is an effective salvage technique for failed biliary cannulation during ERCP. However, it is still difficult to achieve cannulation in some cases, especially using the intrahepatic bile duct (IHBD) approach, which requires complicated guidewire manipulation. EUS-hybrid rendezvous technique (HRV) has been applied as a salvage technique for difficult guidewire placement during EUS-RV with IHBD approach. The aims of this study were to evaluate the efficacy and safety of EUS-HRV using a retrospective study. Database analysis revealed 29 patients who underwent EUS-RV for difficult biliary cannulation. Among them, 8 patients underwent EUS-HRV as a salvage technique for difficult guidewire placement during EUS-RV with the IHBD approach. In EUS-HRV, a 6-French dilator was advanced into the biliary system for better guidewire manipulation. After successful guidewire placement, the EUS scope was exchanged for a duodenoscope, keeping the guidewire and dilator in place. The EUS-placed guidewire was retrieved through the duodenoscope, followed by cannulation over the guidewire. The dilator remained at the fistula until completion of the procedure. The analysis showed that the guidewire placement and the subsequent scope exchange and deep biliary cannulation after the retrieval of the EUS-placed guidewire were successfully conducted for all 8 patients. Mild pancreatitis was recognized as an adverse event in 1 patient. The overall success rate of EUS-RV combined with EUS-HRV was improved up to 90% (26/29). Our results suggested that EUS-HRV can be an effective and safe salvage technique in cases wherein guidewire placement is difficult during EUS-RV with IHBD approach.

Background Combining upper and lower gastrointestinal tract (GI) approaches allows expansion of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) indications for pelvic lesions. The upper GI approach has been used for pelvic lesions around the level of the aortoiliac bifurcation in our institution. The aim of this study is to evaluate the feasibility and safety of EUS-FNA for pelvic lesions via the upper and lower GI approaches. Methods All consecutive patients who underwent EUS-FNA for the pelvic lesion between January 2008 and December 2018 were retrospectively analyzed. Pelvic lesions were defined as lesions located around and below the aortoiliac bifurcation level. The primary outcome was technical success rate, and the secondary outcomes were the diagnostic capability of EUS-FNA for malignancy and the safety. Results EUS-FNA for pelvic lesions was performed in 49 patients: upper and lower GI approaches were used in 28 and 21 patients, respectively. The technical success rates were 91.8% (45/49) in all patients: 89.3% (25/28) and 95.2% (20/21) with the upper and lower GI approaches, respectively. Among patients who achieved technical success, the diagnostic accuracy for malignancy was 97.8% (44/45) in all patients: 100% (25/25) and 95.0% (19/20) with the upper and lower GI approaches, respectively. One (2.0%) patient developed an adverse event of sigmoid colon perforation. Conclusions EUS-FNA for pelvic lesions via the upper and lower GI approaches was a safe, feasible, and effective method, although careful endoscopic manipulation is required to avoid perforation, especially with the lower GI approach. Further large-scale, well-designed studies are needed to validate our findings.