EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score-matched case-control study.

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HGS) is a rescue procedure when ERCP fails. Peritonitis and recurrent biliary obstruction (RBO) are adverse events (AEs) associated with EUS-HGS. Antegrade stent placement across a malignant distal biliary obstruction (DBO) followed by EUS-HGS (EUS-HGAS) creates 2 biliary drainage routes, potentially reducing peritonitis and prolonging time to RBO (TRBO). We compared the outcomes of the 2 techniques. METHODS: Data of consecutive patients with malignant DBO who underwent attempted EUS-HGS or EUS-HGAS across 5 institutions from January 2014 to December 2020 were retrospectively analyzed. A matched cohort of patients was obtained using 1-to-1 propensity score matching. The primary outcome was TRBO, and secondary outcomes were AEs except for RBO and overall survival. RESULTS: Among 360 patients, 283 (176 and 107 in the HGS and HGAS groups, respectively) were eligible. The matched cohorts included 81 patients in each group. AEs developed in 10 (12.3%) and 15 (18.5%) patients (P = .38) in the HGS and HGAS groups, respectively. RBO occurred in 18 and 2 patients in the HGS and HGAS groups, respectively (P < .001). TRBO was significantly longer in the HGAS group (median, 194 days vs 716 days; hazard ratio, .050; 95% confidence interval, .0066-.37; P < .01). However, no significant differences occurred in overall survival between the groups (median, 97 days vs 112 days; hazard ratio, .97; 95% confidence interval, .66-1.4; P = .88). CONCLUSIONS: EUS-HGAS extended TRBO compared with EUS-HGS, whereas AEs, except for RBO and overall survival, did not differ. The longer TRBO of EUS-HGAS could benefit patients with longer life expectancy.

Safety of biliary drainage with 6-mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY.

BACKGROUND AND AIM: The 10-mm self-expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10 mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6-mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. METHODS: This was a single-arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent-related adverse events, and the key secondary endpoint was the non-recurrent biliary obstruction (non-RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. RESULTS: The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent-related adverse event rate was 3.1% (n = 1, acute pancreatitis) (95% confidential interval, 0.00-16.2), which met the criteria to be considered safe. The overall non-RBO rate during the observation period (median 96 days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). CONCLUSIONS: The 6-mm FCSEMS is an extremely safe metallic stent with a low stent-related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non-RBO rate. UMIN Clinical Trial Registry (UMIN-CTR 000041704).

Propensity score matching analysis for clinical impact of braided-type versus laser-cut-type covered self-expandable metal stents for endoscopic ultrasound-guided hepaticogastrostomy.

BACKGROUND: To prevent stent migration during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), intra-scope channel release technique is important, but is unfamiliar to non-expert hands. The self-expandable metal stent (SEMS) is an additional factor to prevent stent migration. However, no comparative studies of laser-cut-type and braided-type during EUS-HGS have been reported. The aim of this study was to compare the distance between the intrahepatic bile duct and stomach wall after EUS-HGS among laser-cut-type and braided-type SEMS. METHODS: To evaluate stent anchoring function, we measured the distance between the hepatic parenchyma and stomach wall before EUS-HGS, one day after EUS-HGS, and 7 days after EUS-HGS. Also, propensity score matching was performed to create a propensity score for using laser-cut-type group and braided-type group. RESULTS: A total of 142 patients were enrolled in this study. Among them, 24 patients underwent EUS-HGS using a laser-cut-type SEMS, and 118 patients underwent EUS-HGS using a braided-type SEMS. EUS-HGS using the laser-cut-type SEMS was mainly performed by non-expert endoscopists (n = 21); EUS-HGS using braided-type SEMS was mainly performed by expert endoscopists (n = 98). The distance after 1 day was significantly shorter in the laser-cut-type group than that in the braided-type group [2.00 (1.70-3.75) vs. 6.90 (3.72-11.70) mm, P < 0.001]. In addition, this distance remained significantly shorter in the laser-cut-type group after 7 days. Although these results were similar after propensity score matching analysis, the distance between hepatic parenchyma and stomach after 7 days was increased by 4 mm compared with the distance after 1 day in the braided-type group. On the other hand, in the laser-cut-type group, the distance after 1 day and 7 days was almost the same. CONCLUSIONS: EUS-HGS using a laser-cut-type SEMS may be safe to prevent stent migration, even in non-expert hands.

Clinical evaluation of a novel drill dilator as the first-line tract dilation technique during EUS-guided biliary drainage by nonexpert hands (with videos).

BACKGROUND AND AIMS: In cases in which tract dilation fails using the initially selected dilation device during EUS-guided hepaticogastrostomy (EUS-HGS), dilation should be re-attempted using another device. However, switching from one device to another during the procedure is often associated with prolonged procedure time and deviation from the correct axis. Therefore, it is highly desired that the initial tract dilation succeeds on the first attempt. Recently, a novel drill dilator has become available in Japan. Because there have been no previous studies comparing this novel device versus others as an initial dilation device, this article reports on the technical feasibility of this novel device for use during EUS-HGS and compares it with a balloon catheter. METHODS: This retrospective study included patients who underwent EUS-HGS using a self-expandable metal stent between October 2021 and October 2022. Excluded from the study were patients who underwent EUS-HGS using a plastic stent or stent deployment without tract dilation. The primary outcome in this study was the technical success rate of initial tract dilation using the drill dilator. This dilator has been available at our hospital since June 2022. Thus, EUS-HGS was performed using this device as the primary dilation device from June 2022 to October 2022. As the control group, we corrected patients who underwent EUS-HGS using a 4-mm balloon catheter as the primary dilation device from October 2021 to May 2022. RESULTS: A total of 49 patients were included: 19 underwent EUS-HGS using the drill dilator and 30 underwent EUS-HGS using a balloon catheter. EUS-HGS using the drill dilator initially was performed mainly by nonexpert hands (n = 19), whereas only some procedures in the balloon catheter group were performed by nonexpert hands (n = 2). Although the initial tract dilation was successful in all patients in the drill dilator group (19 of 19 [100%]) and in 29 (97%) of 30 in the balloon catheter group, additional tract dilation was needed in 73.7% (14 of 19) of the drill dilator group upon insertion of the 8.5F stent delivery system. In contrast, the stent delivery system insertion was successful without additional tract dilation in all patients in the balloon catheter group. CONCLUSIONS: The novel drill dilator might be useful as a dilation device; however, the balloon dilation technique should be selected first upon deploying a dedicated metal stent with an 8.5F stent delivery system.

Predators mitigate the destabilising effects of heatwaves on multitrophic stream communities.

Amidst the global extinction crisis, climate change will expose ecosystems to more frequent and intense extreme climatic events, such as heatwaves. Yet, whether predator species loss-a prevailing characteristic of the extinction crisis-will exacerbate the ecological consequences of extreme climatic events remains largely unknown. Here, we show that the loss of predator species can interact with heatwaves to moderate the compositional stability of ecosystems. We exposed multitrophic stream communities, with and without a dominant predator species, to realistic current and future heatwaves and found that heatwaves destabilised algal communities by homogenising them in space. However, this happened only when the predator was absent. Additional heatwave impacts on multiple aspects of stream communities, including changes to the structure of algal and macroinvertebrate communities, as well as total algal biomass and its temporal variability, were not apparent during heatwaves and emerged only after the heatwaves had passed. Taken together, our results suggest that the ecological consequences of heatwaves can amplify over time as their impacts propagate through biological interaction networks, but the presence of predators can help to buffer such impacts. These findings underscore the importance of conserving trophic structure, and highlight the potential for species extinctions to amplify the effects of climate change and extreme events.

Prospective comparison study between 19-gauge needle with .025-inch guidewire and 22-gauge needle with novel .018-inch guidewire during EUS-guided transhepatic biliary drainage (with video).

BACKGROUND AND AIMS: If the diameter of the intrahepatic bile duct is much less dilated, bile duct puncture with a 19-gauge needle can be challenging during EUS-guided biliary drainage (EUS-BD). These characteristics can decrease the difficulty of bile duct puncture, but use of a 22-gauge needle is less feasible because of poor visibility, maneuverability, and stiffness of the conventional .018-inch guidewire. A novel, improved .018-inch guidewire has recently become available. We conducted a prospective study to evaluate the technical feasibility and safety of EUS-BD in patients with insufficient bile duct dilatation using a 22-gauge needle and the new .018-inch guidewire. METHODS: A 22-gauge needle was used as the puncture needle for intrahepatic bile ducts of diameters <1.5 mm, and a 19-gauge needle was selected for diameters ≥1.5 mm. As the primary endpoint of the study, the technical success rate of EUS-BD using a 22-gauge needle with the novel .018-inch guidewire was evaluated in patients with insufficient dilation of the intrahepatic bile duct. RESULTS: Forty-one patients who required EUS-BD were enrolled (22-gauge needle group, n = 18; 19-gauge needle group, n = 23). Technical success was obtained in all patients in the 19-gauge needle group. In the 22-gauge needle group, technical failure occurred in 2 patients because of nonidentification of the intrahepatic bile duct on EUS (technical success rate, 88.9%), and puncture of the bile duct itself was not performed in these patients. Mean procedure time was similar between the groups. Adverse events were observed in 16.7% of patients (3/16) in the 22-gauge needle group and in 34.8% of patients (8/23) in the 19-gauge needle group. CONCLUSIONS: Outcomes of using a 22-gauge needle with a novel .018-inch guidewire were comparable with a 19-gauge needle with a .025-inch guidewire, even in the case of insufficient intrahepatic bile duct dilatation. These results require verification in a prospective, randomized trial comparing 22-gauge and 19-gauge needles with a larger sample size. (Clinical trial registration number: UMIN000044441.).

Size-dependent growth tactics of a partially migratory fish before migration.

In many migratory species, smaller migrants suffer higher mortality rates during the risky migration. To minimize the size-selective mortality, migrants with smaller body sizes would need to accelerate growth rates or delay migration timing to attain a large enough body size prior to migration. To test these predictions, we investigated size-dependent patterns of growth rates and migration timing of juvenile masu salmon (Oncorhynchus masou) before their oceanic migration. We tracked uniquely marked individuals in a study population consisted of oceanic migrants and river-dwelling residents using mark-recapture surveys and PIT-tag antenna-reader system. Data supported our predictions about size-dependent growth rates and migration timing. For approximately 6 months before outmigration (i.e., between the decision of migration and the start of migration), eventual migrants grew more than residents if their initial size was smaller, but such a difference in growth rate diminished for fish with larger initial sizes. In addition, smaller eventual migrants delayed the timing of outmigration compared to larger individuals, to attain a larger body size in the river prior to migration. These results suggest that size-selective mortality during migration has shaped size-dependent patterns of the pre-migration growth in migratory masu salmon. Size-conditional changes in growth rate and duration of pre-migration period may be an adaptive tactic for the migratory animals.

Expanding indications for endoscopic ultrasound-guided hepaticogastrostomy for patients with insufficient dilatation of the intrahepatic bile duct using a 22G needle combined with a novel 0.018-inch guidewire (with video).

A prerequisite for endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) is adequate dilation of the intrahepatic bile duct. Compared with a 19G needle, the 22G needle offers more flexible manipulation and superior ability to achieve bile duct puncture. However, evidence regarding EUS-HGS using a 22G needle remains limited. The present study evaluated the feasibility and safety of EUS-HGS using a novel 0.018-inch guidewire and 22G needle for patients with insufficient intrahepatic bile duct dilation. If the bile duct diameter was <1.5 mm, a 22G needle was used, and the diameter was ≥1.5 mm; puncture with a 19G needle was first attempted, with the 22G needle being inserted if initial bile duct puncture failed. EUS-HGS using the 22G needle was attempted in a total of 10 patients, including one patient with failed insertion of a 19G needle. Median diameter of the puncture site was 1.2 mm (range 0.5-2.5 mm). Bile duct puncture using the 22G needle was successful in all patients. Insertion of the novel 0.018-inch guidewire was also successful in all patients. However, since tract dilation using an ultra-tapered mechanical dilator failed in two patients, tract dilation was performed using a balloon dilator. Finally, stent deployment was successfully performed in all patients. EUS-HGS using a 22G needle with a novel 0.018-inch guidewire appears safe and feasible.

Novel transluminal treatment protocol for hepaticojejunostomy stricture using covered self-expandable metal stent.

BACKGROUND: Hepaticojejunostomy anastomotic stricture (HJS) is a rare complication after pancreatoduodenostomy. However, the rate of HJS may be increased with the expansion of operative indications, such as intraductal papillary mucinous neoplasm. Recently, the indications for EUS-guided biliary drainage to treat benign biliary disease have expanded. Recently, novel transluminal treatment protocol has been established in our hospital. The aim of this study was thus to evaluate the technical feasibility and safety of our treatment protocol. PATIENTS AND METHOD: Consecutive patients with complications of HJS between January and December 2018 were enrolled in this study. EUS-guided hepaticogastrostomy (HGS) is firstly performed. After 7 days to create the fistula, HGS stent is removed. HJS is transluminally evaluated by a cholangioscope, and antegrade balloon dilation is attempted. After 3 months, if HJS is still presence, antegrade stent deployment is performed using a covered metal stent. Also, after 1 month, antegrade stent removal is transluminally performed. RESULTS: Among total 29 patients, 14 patients were underwent antegrade metal stent deployment. The technical success rate of antegrade stent deployment was 92.9%. Median period of stent placement was 30.5 days (range 28-38 days), and transluminal stent removal was successfully performed in all patients. During follow-up (median 278 days; range 171-505 days), recurrence of HJS was seen in 2 patients. Severe adverse events were not seen in any patients during follow-up period. CONCLUSION: Transluminal stent deployment for HJS under EUS-guidance appears feasible and safe, although further study with a larger sample size and longer follow-up is warranted.

Endoscopic ultrasonography-guided hepaticogastrostomy using a novel laser-cut type partially covered self-expandable metal stent (with video).

Endoscopic ultrasonography (EUS)-guided hepaticogastrostomy (HGS) is of clinical benefit in patients with failed endoscopic retrograde cholangiopancreatography (ERCP). However, some endoscopists are concerned about the potential risk of adverse events. Bile peritonitis due to bile leakage through the fistula is one of the possible adverse events following EUS-HGS. Recently, a novel laser-cut type partially covered self-expandable metal stent (PCSEMS), which is a dedicated stent for EUS-HGS, has become available. This stent has an uncovered part, despite it being a laser-cut type stent, along with a flared end. In addition, it uses a 7-Fr stent delivery. Therefore, tract dilation might not be needed to deploy the stent, which might reduce the incidence of stent migration. In this study, the safety of EUS-HGS using this novel laser-cut type PCSEMS was evaluated by assessing technical success, which was defined as successful stent deployment, and clinical success, which was defined as reduction in serum total bilirubin levels by 50% and resolution of symptoms related to biliary tract obstruction within 2 weeks. Five patients with unresectable malignant biliary obstruction underwent EUS-HGS using the novel stent. Stent deployment was successfully performed without tract dilation in four patients, although tract dilation using a balloon catheter was needed in one patient. Clinical success was obtained in all patients, and adverse events including abdominal pain and bile peritonitis were not observed in any of the patients. EUS-HGS without tract dilation can be safely performed using a novel laser-cut type PCSEMS. A prospective comparative study evaluating this stent versus conventional stents is needed to corroborate our results.

Antiplatelet and/or anticoagulant treatment does not increase hemorrhagic adverse events during EUS-guided biliary drainage.

BACKGROUND AND AIMS: No data appear to have been reported regarding bleeding risk among patients receiving antiplatelet and/or anticoagulant treatment (AP/AC) during EUS-guided biliary drainage (BD) procedures. The aim of this study was to assess whether hemorrhagic adverse events associated with EUS-BD are increased in patients on AP/AC. METHODS: Patients receiving AP/AC who underwent EUS-BD were retrospectively enrolled between May 2015 and August 2019. Patients who did not receive AP/AC and underwent EUS-BD in the same period were also enrolled as a control group. RESULTS: One hundred ninety-five patients who underwent EUS-BD were enrolled in this study. Among these, 154 patients were allocated to the control group and 41 patients to the AP/AC group. Overall frequency of adverse events did not differ significantly between the control group (16.2%, 25/154) and AC/AP group (17.1%, 6/41; P = .80). The overall bleeding event rate was 3.6% (7/195), with no significant difference between the 2 groups. No thromboembolic events were observed with or without interruption of AP/AC. According to logistic regression analysis, the use of AP/AC was not a risk factor significantly associated with bleeding events (odds ratio, 2.96; 95% confidence interval, .56-14.0; P = .18). On the other hand, a long procedure time (>20 minutes) was an independent risk factor associated with bleeding events. CONCLUSIONS: Bleeding events appear to be infrequent among patients who undergo EUS-BD while continuing AP/AC.

Can Iodixanol Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis? A Prospective, Randomized, Controlled Trial.

BACKGROUND: It is yet not clear whether differences in the contrast medium may affect post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). AIM: The aim of this study was to evaluate the rate of PEP between high osmolality contrast medium (HOCM) and iso osmolar medium (IOCM) in a prospective, randomized, controlled trial. METHODS: Patients who were scheduled to undergo a diagnostic or therapeutic procedure under ERCP guidance were included. Patients were excluded from this study if they (1) were < 20 years old; (2) had acute or active pancreatitis; (3) had previously undergone ERCP; (4) had surgical altered upper gastrointestinal tract anatomy; or (5) refused to be involved in this study. RESULTS: Seventy-five patients were randomly assigned to the IOCM group, and 71 patients were assigned to the HOCM group. PEP occurred in 27 patients (18.5%). Although there were no significant differences, the severe grade of PEP was more frequent in the HOCM group than in the IOCM group (p = 0.08). The results of the multivariate analyses for PEP were not identified as independent risk factors. Also, independent risk factors of hyperamylasemia were performing pre-cut. In subgroup analyses, HOCM was an independent risk factor for hyperamylasemia. CONCLUSIONS: In conclusion, HOCM may play a role in the development of PEP and in PEP severity grade.

Electrohydraulic Lithotripsy for Pancreatic Duct Stones Under Digital Single-Operator Pancreatoscopy (with Video).

BACKGROUND: Recently, a digital single-operator cholangiopancreatoscope (DSOC) has become available. This system allows the performance of electrohydraulic lithotripsy (EHL) even within the main pancreatic duct (MPD). However, there are only few reports of EHL for MPD stones using SPY-DS. AIMS: The aim of this study was to evaluate the technical feasibility and efficacy of EHL for MPD stones under DSOC guidance. METHODS: Between October 2016 and August 2017, patients with MPD stones were retrospectively enrolled in this study. The presence of MPD stones was diagnosed by endoscopic ultrasound and MRCP. The patients' baseline characteristics and those of the stones, including their size, number, and site in the MPD, number of EHL procedures, and adverse events, were reviewed. RESULTS: A total of 21 patients were retrospectively enrolled. The etiologies of chronic pancreatitis were idiopathic (n = 4) and alcohol induced (n = 17). The pancreatic stone was variously located in the head (n = 6), body (n = 11), tail (n = 1), head and body (n = 2), and body and tail (n = 1) of the pancreas. Median pancreatic stone size was 12 mm, and the mean number of ERCP sessions was 1.29 (range 1-3). EHL was successfully performed in 15 patients (85.7%, 18/21), and the rate of complete stone clearance was 88.2% (18/21). Severe adverse events were not seen in any of the patients, although one patient developed mild acute pancreatitis. CONCLUSIONS: In conclusion, although additional case reports and prospective studies are needed, EHL under DSOC may be an option to treat MPD stones.

Clinical efficacy and safety of endoscopic ultrasound-guided gallbladder drainage replacement of percutaneous drainage: A multicenter retrospective study.

OBJECTIVES: Percutaneous transhepatic gallbladder drainage (PTGBD) is widely used for patients with acute cholecystitis. There are little data on the efficacy and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) replacement of PTGBD in patients who cannot undergo cholecystectomy. METHODS: This multicenter retrospective study in Japan reviewed records of patients who underwent EUS-GBD to replace PTGBD between January 2010 and December 2017. Outcomes evaluated included technical success, defined as successful stent placement between the gastrointestinal lumen and the gallbladder; clinical success, defined as subsequent removal of the percutaneous catheter; adverse events; and stent patency. RESULTS: EUS-GBD was performed in 21 patients (14 women, mean age 77.5 ± 8.0 years) to replace PTGBD that had been instituted for acute cholecystitis (n = 19) or obstructive jaundice (n = 2). Technical success was achieved in 19 (90.5%). The median period from PTGBD placement to EUS-GBD was 11 days (range, 6-68 days). The mean procedure time was 19.5 ± 5.1 min. No early adverse events were observed. There were three late adverse events, distal stent migration in two cases and stent occlusion causing recurrent cholecystitis in one patient. Reintervention was required in two patients. The percutaneous catheter was removed after EUS-GBD in 17 patients at a median of 7 days (range, 2-20 days). The duration of stent patency was 139 days (range, 8-664 days). CONCLUSIONS: Where ongoing gallbladder drainage is required, conversion from PTGBD to EUS-GBD is a feasible, effective, and safe technique for patients who cannot undergo cholecystectomy.

Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction: Multicenter, randomized, clinical trial.

BACKGROUND AND AIM: Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be carried out by two different approaches: choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS). We compared the efficacy and safety of these approaches in malignant distal biliary obstruction (MDBO) patients using a prospective, randomized clinical trial. METHODS: Patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography were randomly selected for either CDS or HGS. The procedures were carried out at nine tertiary centers from September 2013 to March 2016. Primary endpoint was technical success rate, and the noninferiority of HGS to CDS was examined with a one-sided significance level of 5%, where the noninferiority margin was set at 15%. Secondary endpoints were clinical success, adverse events (AE), stent patency, survival time, and overall technical success including alternative EUS-BD procedures. RESULTS: Forty-seven patients (HGS, 24; CDS, 23) were enrolled. Technical success rates were 87.5% and 82.6% in the HGS and CDS groups, respectively, where the lower limit of the 90% confidence interval of the risk difference was -12.2% (P = 0.0278). Clinical success rates were 100% and 94.7% in the HGS and CDS groups, respectively (P = 0.475). Overall AE rate, stent patency, and survival time did not differ between the groups. Overall technical success rates were 100% and 95.7% in the HGS and CDS groups, respectively (P = 0.983). CONCLUSIONS: This study suggests that HGS is not inferior to CDS in terms of technical success. When one procedure is particularly challenging, readily switching to the other could increase technical success.