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Background Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy. Methods Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding. Results The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1–47.5] vs. 15.0 % [95 %CI 7.1–29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7–31.9] vs. 5.3 % [95 %CI 1.5–17.3]), and all cases were mild. Conclusions Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.

Background Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) and fine-needle biopsy (FNB) are the current standard of care for sampling pancreatic and peripancreatic masses. Recently, a 22G EUS-FNB needle with Franseen geometry was developed, and this device was also introduced in a 25G platform. We compared the performance of the 25G and 22G Franseen needles for EUS-guided sampling of pancreatic and peripancreatic solid masses. Methods We conducted a parallel-group randomized non-inferiority trial at a tertiary-care center from November 2018 to May 2019. The primary outcome was the quality of the histologic core assessed using the Gerke score. The optimal histologic core is indicated by a Gerke score of 4 or 5, which enables optimal histologic interpretation. The overall diagnostic accuracy and adverse event rate were also evaluated. Results 140 patients were enrolled and randomized (1:1) to the 25G and 22G groups. Tissue acquisition by EUS-FNB was successful in all patients. The optimal histologic core procurement rate was 87.1 % (61/70) for the 25G needle vs. 97.1 % (68/70) for the 22G; difference −10 % (95 % confidence interval −17.35 % to −2.65 %). High quality specimens were more frequently obtained in the 22G group than in the 25G group (70.0 % [49/70] vs. 28.6 % [20 /70], respectively; P Conclusions The 25G Franseen needle was inferior to the 22G needle in histologic core procurement. Therefore, for cases in which tissue architecture is pivotal for diagnosis, a 22G needle, which procures relatively higher quality specimens than the 25G needle, should be used.

Background Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration. Methods 68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates. Results The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %; P = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217]; P = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups. Conclusions Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.

Background Single-operator cholangioscopy (SOC) provides an accurate diagnosis of indeterminate pancreaticobiliary strictures. However, the procedure is expensive and can be performed using only limited accessories. Therefore, we devised a novel tube-assisted biopsy (TAB) technique and evaluated its feasibility, diagnostic yield, and safety for indeterminate pancreaticobiliary strictures. Methods The medical records of patients with indeterminate pancreaticobiliary strictures who underwent TAB between September 2018 and July 2019 were reviewed. We assessed the technical success rate, adverse event rate, sensitivity, specificity, and overall accuracy of TAB in differentiating malignant from benign lesions. Results TABs were performed in 16 patients: 12 had biliary strictures; four had pancreatic strictures. The technical success rate was 93.7 % (15/16), and the sensitivity, specificity, and overall accuracy of TAB were 87.5 %, 100 %, and 93.7 %, respectively. No serious adverse events occurred either during or after the procedure in any of the patients. Conclusions TAB has an acceptable accuracy for the diagnosis of indeterminate pancreaticobiliary strictures and may represent a useful diagnostic method in patients where SOC cannot be implemented.

Background Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been increasingly used for the management of various solid pancreatic tumors. This study aimed to evaluate the feasibility and safety of EUS-RFA for serous cystic neoplasms (SCNs). Methods 13 patients with microcystic SCNs with honeycomb appearance underwent EUS-RFA using a 19-gauge RFA needle. Before ablation, cystic fluid was aspirated until a thin layer of fluid remained. Results EUS-RFA was successful in all patients. Seven patients underwent a single session and the remaining six patients underwent a second session of EUS-RFA. One patient (7.7 %) experienced self-limited abdominal pain after EUS-RFA. During a median follow-up period of 9.21 months (interquartile range [IQR] 5.93 – 15.38), the median volume of the SCNs decreased from 37.82 mL (IQR 15.03 – 59.53) at baseline to 10.95 mL (IQR 4.79 – 32.39) at the end of follow-up. A radiologic partial response was achieved in eight patients (61.5 %). Conclusions EUS-RFA is technically feasible and showed an acceptable rate of adverse events for patients with SCNs. A long-term follow-up study is required to evaluate the efficacy of EUS-RFA.

Background Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population. Methods This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first. Results 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy. Conclusion In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.

Background and study aims The aim of this study was to investigate the long-term outcomes after endoscopic ultrasound (EUS)-guided pancreatic cyst ablation. Patients and methods In a single-center, prospective study, 164 patients with pancreatic cysts underwent EUS-guided cyst ablation using ethanol with paclitaxel. The inclusion criteria were as follows: unilocular or oligolocular cysts; clinically indeterminate cysts that required EUS fine-needle aspiration; and/or cysts that grew during the observation period. Treatment response was classified as complete resolution, partial resolution, or persistent cyst, with Results The median largest diameter of the cyst was 32 mm and the median volume was 17.1 mL. Based on cyst fluid analysis there were 71 mucinous cystic neoplasms, 16 serous cystic neoplasms, 11 intraductal papillary mucinous neoplasms, 3 pseudocysts, and 63 indeterminate cysts. Sixteen treated patients (9.8 %) had adverse events (1 severe, 4 moderate, and 11 mild). Treatment response was as follows: complete resolution in 114 (72.2 %), partial resolution in 31 (19.6 %), and persistent cysts in 13 (8.2 %). Twelve of the 13 patients with persistent cysts underwent surgery. During clinical and imaging follow-up (median 72 months, interquartile range 50 – 85 months) of the 114 patients with complete resolution, only two patients (1.7 %) showed cyst recurrence. Based on multivariate analysis, the absence of septa (odds ratio [OR] 7.12, 95 % confidence interval [CI] 2.72 – 18.67) and cyst size less than 35 mm (OR 2.39, 95 %CI 1.11 – 5.16) predicted complete resolution. Conclusion Among patients with pancreatic cysts in whom complete resolution was achieved after EUS-guided cyst ablation, 98.3 % remained in remission at 6-year follow-up. Unilocular form and small cyst size were predictive of complete resolution. This treatment approach may be an effective and durable alternative to surgery.Trial registered at ClinicalTrials.gov (NCT 00689715).

Background and study aim Percutaneous transhepatic biliary drainage (PTBD) is a rescue procedure after a failed endoscopic retrograde cholangiopancreatography. As PTBD causes patient discomfort, conversion of the PTBD to internal biliary stenting (PTBDS) may be required; however, PTBDS is sometimes difficult because of the tight stricture. We evaluated the efficacy and safety of conversion of external PTBD to endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) after failed PTBDS. Patients and methods A total of 16 patients with malignant distal biliary obstruction who underwent conversion of external PTBD to EUS-HGS after failed PTBDS were enrolled from two institutions in Korea and Japan. Data were analyzed retrospectively. Results The technical and clinical success rates were 100 % and 81 %, respectively. Early adverse events developed in two patients: proximal stent migration (n = 1), and cholecystitis (n = 1). Stents were occluded or migrated distally in five patients. The mean duration of stent patency was 402 days. Conclusions Conversion of external PTBD to EUS-HGS may be a good rescue option after failed PTBDS.

Peripancreatic fluid collections (PFCs) have been adequately drained using multiple plastic stents placed in a single-step endoscopic ultrasound (EUS) procedure. Recent reports have presented the usefulness of metal stents for this procedure; however, there has been no prospective comparative study on their effectiveness and safety. We conducted a prospective randomized study to compare multiple plastic stents with fully covered, self-expanding metal stents (FCSEMSs) for the drainage of PFCs.Between January 2012 and May 2013, patients with PFCs demonstrated by various modalities were enrolled in our study. Patients were randomly assigned to receive either a FCSEMS or plastic stents for EUS-guided PFC drainage. The procedure time, technical success rate, and adverse event rates of the PFCs were evaluated.50 patients (41 men) were included and randomly assigned to either the FCSEMS group (n = 25) or the plastic stent group (n = 25). The median procedure time with FCSEMS was significantly shorter than with plastic stents (15.0 min vs. 29.5 min, P 0.01). The technical success rate was 100 % for both groups. The clinical success rate was 20 out of 23 for FCSEMS and 20 out of 22 for plastic stents (P = 0.97). No adverse events occurred in the FCSEMS group, while adverse events occurred in two patients in the plastic stent group (P = 0.16). One recurrence was observed during follow-up in the FCSEMS group and none in the plastic stent group (P = 0.15).EUS-guided PFC drainage with FCSEMSs is comparable to such drainage with plastic stents in terms of technical feasibility, efficacy, and safety; however, the use of FCSEMSs may also simplify and shorten the procedure.KCT0000766 (https://cris.nih.go.kr).

Background and study aims Owing to the indistinctive endoscopic appearance of gastric intestinal metaplasia (GIM), gastric intraepithelial neoplasia (GIN), and early gastric cancer (EGC), a significant number of such lesions may be missed during surveillance endoscopy. The aim of this clinical trial was to assess the value of combined computed virtual chromoendoscopy (flexible spectral imaging color enhancement [FICE]) and probe-based confocal laser endomicroscopy (pCLE) for in vivo detection of GIM, GIN, and EGC. Patients and methods This was a multicenter, randomized controlled trial performed in 238 patients at four tertiary centers. Patients were randomized to FICE-guided pCLE with targeted biopsies (group A) or FICE with standard biopsies (group B). The diagnostic yield of GIM, GIN, or EGC was compared between the two groups. Results On a per-patient assessment, the diagnostic yield for GIM/GIN/EGC was 73.3 % (88/120) in group A and 63.6 % (75/118) in group B (P = 0.09). On a per-biopsy analysis, FICE-guided pCLE with targeted biopsies significantly increased the diagnostic yield of GIM/GIN/EGC vs. FICE with standard biopsies, from 31.5 % (252/800) to 75.1 % (313/417) (P Conclusions Real-time pCLE and targeted biopsies after FICE improved the diagnostic yield for the detection of GIM, GIN, and EGC, and only required about half the number of biopsies vs. FICE with standard biopsies. This may allow a better regimen for endoscopic surveillance and subsequent treatment of patients with premalignant and malignant gastric abnormalities.Trial registered at ClinicalTrials.gov (NCT02515721).

Background and study aims: New methods for the endoscopic selective ablation of locally advanced pancreaticobiliary malignancies as a minimally invasive approach are needed. Our aim was to examine the feasibility and safety of endoscopic ultrasonography (EUS)-guided photodynamic therapy (PDT) for local tumor control in patients with locally advanced pancreaticobiliary malignancies. Patients and methods: A chlorin e6 derivative and a flexible laser-light catheter were used to perform EUS-guided PDT in four patients with locally advanced pancreaticobiliary malignancies. Results: EUS-guided PDT was technically feasible in all four patients with locally advanced pancreaticobiliary malignancies (two in the caudate lobe of the liver, one in the far distal bile duct, and one in the tail of the pancreas). No treatment-related complications occurred. The median volume of necrosis produced by PDT was 4.0 cm3 (range 0.7 – 11.3). Disease remained stable in all four patients during a median follow-up of 5 months (range 3 – 7). Conclusion: These preliminary data suggest that EUS-guided PDT with a second-generation photosensitizer and a flexible laser probe is feasible and safe.

A51-year-oldmanwith chronicpancreatitis presented with recurrent postprandial epigastric pain. Computed tomography (CT) of the abdomen revealed a9-mmpancreaticolith in the main pancreatic duct (MPD) of the head portion. Endoscopic retrograde cholangiopancreatography (ERCP)wasperformed to remove the pancreaticolith. After the pancreatic duct had been cannulated, sphincterotomy was performed. We attempted to remove the pancreaticolith with a lithotripsy basket (GML-06-26-430; MediGlobeGmbH,Germany); however, thebasket became trapped by the pancreaticolith in theMPD.Mechanical lithotripsy (StoneBuster; Medi-Globe GmbH, Germany) was tried (●" Fig.1a), but the wire of the basket fractured and the pancreaticolith became tangled up in the fractured basket (●" Fig.1b). Attempted removal of the fractured basket and pancreaticolith complex failed because they were tightly impacted in the narrow portion of the MPD. To minimize the risk of pancreatitis due to obstruction of the MPD, a 5-Fr plastic stent was inserted through the minor duodenal papilla. Extracorporeal shock wave lithotripsy (ESWL) to the impacted pancreaticolith was started on the day after the ERCP using a third-generation lithotriptor (PiezoLith 3000 plus; ELvation Medical GmbH, Germany) [1]. The repeated ESWL could be focused accurately on the pancreaticolith because it was held tightly together with the fractured basket in the pancreatic duct. After the 11th ESWL treatment (3000 shocks per session at an intensity of 16 on a scale of 1–20), a further ERCP was attempted. A guidewire was successfully passed through the impacted basket and stone. After a 6-mm balloon (Hurricane Rx hydrostatic balloon; Boston Scientific, Natick Massachusetts, USA) had been dilated in the narrow portion of the MPD, the fractured basket was removed with a forceps (FB-19N-1; Olympus, Tokyo, Japan) (●" Figs. 2–4). Following this, the fragmented pancreaticolith was also successfully removedby sweepingwith thebasket and balloon (●" Fig.5).

Background and study aim: Fully covered, self-expandable metal stents (FCSEMSs) are acceptable tools for treating benign biliary stricture (BBS). However, little is known about the long-term outcomes of this technique. The aim of the present study was to evaluate the procedural and long-term outcomes of FCSEMSs for treating BBSs. Patients and methods: A total of 134 consecutive patients (median age 56 years; range 21 – 83) with BBS were retrospectively reviewed. The main outcomes were technical and clinical success, stricture resolution, recurrence, and adverse events. Outcomes were analyzed by reviewing patient medical records. Results: The success rates of FCSEMS placement and removal were 99.3 % and 98.2 %, respectively. Stricture resolution occurred in 103/132 (78.0 %) of the patients (median stent duration, 93 days; range 1 – 489). The associated factors for stricture resolution were longer stent indwelling period (≥ 120 days) and absence of stent migration. Stricture recurrence was seen in 26/103 patients (25.2 %; 95 % confidence interval [CI] 0.17 – 0.34) within a median of 390 days (range 4 – 903 days). Chronic pancreatitis was associated with stricture recurrence (hazard ratio [HR] 2.59, 95 %CI 1.20 – 5.61; P = 0.02). Stent migration occurred in 41/132 patients (31.1 %; 95 %CI 0.23 – 0.39). The FCSEMS with anchoring flaps appeared to protect against stent migration (HR 0.22, 95 %CI 0.08 – 0.63; P Conclusion: FCSEMSs had a high success rate for BBS resolution. Longer indwelling periods and the absence of stent migration might be important factors for stricture resolution.