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Background: Endoscopic-ultrasound-guided gastrojejunostomy (EUS-GJ) can be a new alternative for patients with malignant afferent loop syndrome (MALS). However, a fully covered self-expandable metal stent (FCSEMS) has not been well investigated in this setting. Methods: This is a multicenter retrospective cohort study. Consecutive patients that underwent EUS-GJ using a FCSEMS for MALS between April 2017 and November 2022 were enrolled. Primary outcomes were technical and clinical success rates. Secondary outcomes were adverse events, recurrent symptoms, and overall survival. Results: Twelve patients (median age: 67.5 years (interquartile range: 58–74.8); 50% male) were included. The most common primary disease and type of previous surgery were pancreatic cancer (67%) and pancreatoduodenectomy (75%), respectively. Technical success and clinical success were achieved in all patients. Procedure-related adverse events occurred in one patient (8%) with mild peritonitis. During a median follow-up of 96.5 days, one patient (8%) had recurrent symptoms due to the EUS-GJ stent dysfunction; including biliary events unrelated to the EUS-GJ stent, five patients (42%) had recurrent events. The median overall survival was 137 days. Nine patients (75%) died due to disease progression. Conclusions: EUS-GJ with a FCSEMS seems safe and effective for MALS with high technical and clinical success rates and an acceptable recurrence rate.

CO2 insufflation has proven effective in reducing patients’ pain after colonoscopies but has not been examined in esophagogastroduodenoscopies. Therefore, we examined the effect of CO2 insufflation in examinees who underwent transnasal endoscopies without sedation. This study is a single-center, prospective, double-blind, case-control trial conducted between March 2017 and August 2018. Subjects were assigned weekly to receive insufflation with either CO2 or air. The primary outcome was improvement of abdominal pain and distension at 2 h and 1-day postprocedure. In total, 336 and 338 examinees were assigned to the CO2 and air groups, respectively. Visual analog scale (VAS) scores for abdominal distension (15.4 vs. 25.5; p < 0.001) and distress from flatus (16.0 vs. 28.8; p < 0.001) at 2 h postprocedure were significantly reduced in the CO2 group. VAS scores for pain during the procedure (33.5 vs. 37.1; p = 0.059) and abdominal pain after the procedure (3.9 vs. 5.7; p = 0.052) also tended to be lower at 2 h postprocedure, but all parameters showed no significant difference at 1-day postprocedure. All procedures were safely completed through the planned program, and no apparent adverse events requiring treatment or follow-up occurred. In conclusion, CO2 insufflation may reduce postprocedural abdominal discomfort from transnasal esophagogastroduodenoscopies. (UMIN000028543).

Aims: This study aimed to evaluate the effectiveness and safety of stenting with a flexible braided self-expandable metal stent (SEMS) for unresectable malignant gastric outlet obstruction (GOO). Methods: Palliative stenting was prospectively carried out at seven university hospitals between October 2017 and August 2020. All procedures were performed using a flexible branded SEMS of the same brand. The primary endpoint was clinical success rate at 7 days after stenting. Secondary endpoints were procedural success rate, adverse events, recurrent gastric outlet obstruction (RGOO), and patient survival time. Results: Sixty patients were enrolled. The procedural and clinical success rates were 100% and 90%, respectively. RGOO occurred in 15 cases (25%). Adverse events other than RGOO were found in seven cases (12%). The 50% survival time was 75.5 days (range: 52–97 days). Median expansion rates at 1, 3, and 7 days after stenting were 55%, 65%, and 75%, respectively. Conclusions: A flexible braided stent woven with relatively thin wires was used for malignant GOO. Despite a gradual expansion with slightly lower expansile force, the stent functioned sufficiently well and showed favorable results. Clinical Trials Registry ID: UMIN000029496.

(1) Background: Endoscopic colorectal stenting with high technical success and safety is essential in discussing the oncological outcomes for the management of malignant colorectal obstruction. Mechanical properties of self-expandable metal stents are usually considered to affect clinical outcomes. (2) Methods: A multicenter, prospective study was conducted in Japan. A self-expandable metal stent with low axial force was inserted endoscopically. The primary endpoint was clinical success, defined as the resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. Short-term outcomes of 7 days were evaluated in this study. (3) Results: Two hundred and five consecutive patients were enrolled. Three patients were excluded, and the remaining 202 patients were evaluated. The technical and clinical success rates were 97.5% and 96.0%, respectively. Major stent-related adverse events included stent migration (1.0%), insufficient stent expansion (0.5%), and stent occlusion (0.5%). No colonic perforation was observed. There were two fatal cases (1%) which were not related to stent placement. (4) Conclusions: The placement of self-expandable metal stents with low axial force is safe with no perforation and showed high technical and clinical success rates in short-term outcomes for the management of malignant colorectal obstruction.

Background: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is becoming increasingly popular. However, the risk factors for stent migration into the abdominal cavity remain unknown. Methods: Forty-eight patients undergoing EUS-HGS with placement of a long, partially covered self-expandable metallic stent (LPC-SEMS) were studied retrospectively to identify risk factors of stent migration. We determined the technical and functional success rates, and recorded adverse events, including stent migration. Results: EUS-HGS was technically successful in all patients. However, stent migration was evident in five patients (one actual and four imminent, 10%). Stent migration into the abdominal cavity was observed in one patient (2%), and the other four cases required additional procedures to prevent migration (8%). Logistic regression analysis revealed that the risk of stent migration increased as the initial (pre-procedure) distance between the stomach and liver at the puncture site increased (p = 0.012). Conclusions: A longer distance between the stomach and liver at the puncture site increased the risk of stent migration. However, during EUS-HGS, it is difficult to adjust the puncture position. It is important to ensure that the proportion of the stent in the stomach is large, the use of a self-anchoring stent may be optimal.

Background and aims: The goals of the management of benign biliary stricture (BBS) are to relieve symptoms and resolve short-/long-term stricture. We performed fully covered self-expandable metallic stent (hereafter, FCSEMS) placement for BBS using various methods and investigated the treatment outcomes and adverse events (AEs). Methods: We retrospectively studied patients who underwent FCSEMS placement for refractory BBS through various approaches between January 2017 and February 2020. FCSEMS were placed for 6 months, and an additional FCSEMS was placed if the stricture had not improved. Technical success rate, stricture resolution rate, and AE were measured. Results: A total of 26 patients with BBSs that were difficult to manage with plastic stents were included. The mean overall follow-up period was 43.3 ± 30.7 months. The cause of stricture was postoperative (46%), inflammatory (31%), and chronic pancreatitis (23%). There were four insertion methods: endoscopic with duodenoscopy, with enteroscopy, EUS-guided transmural, and percutaneous transhepatic. The technical success rate was 100%, without any AE. Stricture resolution was obtained in 19 (83%) of 23 cases, except for three cases of death due to other causes. Stent migration and cholangitis occurred in 23% and 6.3%, respectively. Stent fracture occurred in two cases in which FCSEMSs were placed for more than 6 months (7.2 and 10.3 months). Conclusion: FCSEMS placement for refractory BBS via various insertion routes was feasible and effective. FCSEMSs should be exchanged every 6 months until stricture resolution because of stent durability. Further prospective study for confirmation is required, particularly regarding EUS-guided FCSEMS placement.

Various procedures are available for pancreato-biliary (PB) endoscopic interventions [...]

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%, p = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups (p = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%, p = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO.

Background: Endoscopic management of common bile duct stones (CBDS) is standard; however, various techniques are performed via the papilla, and the best procedure in terms of both efficacy and safety has not been determined. Methods: Endoscopic procedures were classified into five categories according to endoscopic sphincterotomy (EST) and balloon dilation (BD): (1) EST, (2) endoscopic papillary BD (≤10 mm) (EPBD), (3) EST followed by BD (≤10 mm) (ESBD), (4) endoscopic papillary large BD (≥12 mm) (EPLBD), and (5) EST followed by large BD (≥12 mm) (ESLBD). We performed a literature review of prospective and retrospective studies to compare efficacy and adverse events (AEs). Each procedure was associated with different efficacy and AE profiles. Results: In total, 19 prospective and seven retrospective studies with a total of 3930 patients were included in this study. For EST, the complete stone removal rate at the first session, rate of mechanical lithotripsy (ML), and rate of overall AEs in EST were superior to EPBD, but a higher rate of bleeding was found for EST. Based on one retrospective study, complete stone removal rate at the first session, rate of ML, and rate of overall AEs were superior for ESBD vs. EST, and the rate of bleeding for the former was also lower. Complete stone removal rate at the first session and rate of ML for ESLBD were superior to those for EST, with no significant difference in rate of AEs. For EST vs. EPLBD, complete stone removal rate at the first session and rate of ML were superior for the latter. For EPLBD vs. ESLBD, the efficacy and safety were similar. Conclusions: ESBD is considered the best procedure for the management of small CBDS, but strong evidence is lacking. For large CBDS, both ESLBD and EPLBD are similar.

Background: The selection of an approach route in endoscopic ultrasound-guided rendezvous (EUS-RV) for failed biliary cannulation is complicated. We proposed an algorithm for EUS-RV. Methods: We retrospectively evaluated consecutive EUS-RV cases between April 2017 and July 2020. Puncturing the distal extrahepatic bile duct (EHBD) from the duodenal second part (D2) (DEHBD/D2 route) was attempted first. If necessary, puncturing the proximal EHBD from the duodenal bulb (D1) (PEHBD/D1 route), puncturing the left intrahepatic bile duct (IHBD) from the stomach (LIHBD/S route), or puncturing the right IHBD from the D1 (RIHBD/D1 route) were attempted in this order. Results: A total of 16 patients were included. The DEHBD/D2 route was used in 10 (62.5%) patients. The PEHBD/D1 route was attempted in five (31.3%) patients, and the biliary puncture failed in one patient in whom the RIHBD/D1 route was used because of tumor invasion to the left hepatic lobe. The LIHBD/S route was applied in one (6.3%) patient. Successful biliary cannulation was achieved in all patients eventually. The time from the puncture to the guidewire placement in the DEHBD/D2 route (3.5 min) was shorter than that in other methods (14.0 min) (p = 0.014). Adverse events occurred in one (6.3%) patient with moderate pancreatitis. Conclusions: The proposed algorithm might be useful for the selection of an appropriate approach route in EUS-RV.

Background: The guidewire (GW) plays an important role in pancreatobiliary endoscopy. GW quality is a critical factor in the effectiveness and efficiency of pancreatobiliary endoscopy. In this study, we evaluate a new 0.025 inch multipurpose endoscopic GW: the M-Through. Methods: Our study was a multicenter retrospective analysis. We enrolled patients who underwent endoscopic procedures using the M-Through between May 2018 and April 2020. Patients receiving the following endoscopic treatments were enrolled: common bile duct (CBD) stone extraction, endoscopic drainage for distal and hilar malignant biliary obstruction (MBO), and endoscopic drainage for acute cholecystitis. For each procedure, we examined the rate of success without GW exchange. Results: A total of 170 patients (80 with CBD stones, 60 with MBO, and 30 with cholecystitis) were enrolled. The rate of completion without GW exchange was 100% for CBD stone extraction, 83.3% for endoscopic drainage for MBO, and 43.3% for endoscopic drainage for cholecystitis. In unsuccessful cholecystitis cases with the original GW manipulator, 1 of 8 cases succeeded in the manipulator exchange. Including 6 cases who changed GW after the manipulator exchange, 11 of 16 cases succeeded in changing GW. There was significant difference in the success rate between the manipulator exchange and GW exchange (p = 0.03). The insertion of devices and stent placement after biliary cannulation (regardless of type) were almost completed with M-through. We observed no intraoperative GW-related adverse events such as perforation and bleeding due to manipulation. Conclusion: The 0.025 inch M-Through can be used for endoscopic retrograde cholangiopancreatography-related procedures efficiently and safely. Our study found high rates of success without GW exchange in all procedures except for endoscopic drainage for cholecystitis. This GW is considered (1) excellent for supportability of device insertion to remove CBD stones, (2) good for seeking the biliary malignant stricture but sometimes need the help of a hydrophilic GW, (3) suboptimal for gallbladder drainage that require a high level of seeking ability.

The emergency declaration (ED) associated with the coronavirus disease-2019 (COVID-19) pandemic in Japan had a major effect on the management of gastrointestinal endoscopy. We retrospectively compared the number of pancreaticobiliary endoscopies and newly diagnosed pancreaticobiliary cancers before (1 April 2018 to 6 April 2020), during (7 April to 25 May 2020), and after the ED (26 May to 31 July). Multiple comparisons of the three groups were performed with respect to the presence or absence of symptoms and clinical disease stage. There were no significant differences among the three groups (Before/During/After the ED) in the mean number of diagnoses of pancreatic cancer and biliary cancer per month in each period (8.0/7.5/7.5 cases, p = 0.5, and 4.0/3.5/3.0 cases, p = 0.9, respectively). There were no significant differences among the three groups in the number of pancreaticobiliary endoscopies (EUS: endoscopic ultrasonography/ERCP: endoscopic retrograde cholangiopancreatography) per month (67.8/62.5/69.0 cases, p = 0.7 and 89.8/51.5/86.0 cases, p = 0.06, respectively), whereas the number of EUS cases decreased by 42.7% between before and during the ED. There were no significant differences among the three groups in the presence or absence of symptoms at diagnosis or clinical disease stage. There was no significant reduction in the newly diagnosed pancreaticobiliary cancer, even during the ED. The number of ERCP cases was not significantly reduced as a result of urgent procedures, but the number of EUS cases was significantly reduced.

Background: Endoscopic biliary stent placement is the standard of care for biliary strictures, but stents across the papilla are prone to duodenobiliary reflux, which can cause stent occlusion. Preliminary studies of “inside stents” placed above the papilla showed encouraging outcomes, but prospective data with a large cohort were not reported. Methods: This was a prospective multicenter registry of commercially available inside stents for benign and malignant biliary strictures. Primary endpoint was recurrent biliary obstruction (RBO). Secondary endpoints were technical success of stent placement and removal, adverse events, and stricture resolution. Results: A total of 209 inside stents were placed in 132 (51 benign and 81 malignant) cases with biliary strictures in 10 Japanese centers. During the follow-up period of 8.4 months, RBO was observed in 19% of benign strictures. The RBO rate was 49% in malignant strictures, with the median time to RBO of 4.7 months. Technical success rates of stent placement and removal were both 100%. The adverse event rate was 8%. Conclusion: This prospective multicenter study demonstrated that inside stents above the papilla were feasible in malignant and benign biliary strictures, but a randomized controlled trial is warranted to confirm its superiority to conventional stents across the papilla.

Endoscopic drainage and necrosectomy are now accepted treatment approaches for patients with symptomatic walled-off pancreatic necrosis (WON). The current recommendations advocate step-up approaches for the treatment of symptomatic WON. Previous recommendations stipulated that endoscopic intervention should be delayed until more than four weeks after the onset. Recent data on early drainage have been increasing and this option might be considered in well-encapsulated cases, but the percutaneous route is preferred if the drainage is performed within two weeks after onset or in nonencapsulated cases. Recently, additional drainage methods, such as the multiple gateway technique and multiple stent placement, have been developed to open up multiple dead spaces in the WON cavity. Endoscopic necrosectomy could be performed via the transluminal route or percutaneous route after failed initial and additional drainage procedures. The use of novel lumen-apposing stents is a promising treatment option that could reduce the number of steps, the procedure time, and the overall number of necrosectomies.

Intraductal papillary neoplasm of the bile duct (IPNB), a pre-invasive neoplasm of the bile duct, is being established pathologically as a precursor lesion of invasive cholangiocarcinoma (CCA), and at the time of surgical resection, approximately half of IPNBs show stromal invasion (IPNB associated with invasive carcinoma). IPNB can involve any part of the biliary tree. IPNB shows grossly visible, exophytic growth in a dilated bile duct lumen, with histologically villous/papillary neoplastic epithelia with tubular components covering fine fibrovascular stalks. Interestingly, IPNB can be classified into four subtypes (intestinal, gastric, pancreatobiliary and oncocytic), similar to intraductal papillary mucinous neoplasm of the pancreas (IPMN). IPNBs are classified into low-grade and high-grade based on lining epithelial features. The new subclassification of IPNB into types 1 (low-grade dysplasia and high-grade dysplasia with regular architecture) and 2 (high-grade dysplasia with irregular architecture) proposed by the Japan–Korea pathologist group may be useful in the clinical field. The outcome of post-operative IPNBs is more favorable in type 1 than type 2. Recent genetic studies using next-generation sequencing have demonstrated the existence of several groups of mutations of genes: (i) IPNB showing mutations in KRAS, GNAS and RNF43 belonged to type 1, particularly the intestinal subtype, similar to the mutation patterns of IPMN; (ii) IPNB showing mutations in CTNNB1 and lacking mutations in KRAS, GNAS and RNF43 belonged to the pancreatobiliary subtype but differed from IPMN. IPNB showing mutation of TP53, SMAD4 and PIK3CA might reflect complicated and other features characterizing type 2. The recent recognition of IPNBs may facilitate further clinical and basic studies of CCA with respect to the pre-invasive and early invasive stages.