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.

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.

Gastrojejunostomy versus endoscopic duodenal stent placement for gastric outlet obstruction in patients with unresectable pancreatic cancer: a propensity score-matched analysis.

BACKGROUND: Treatments for patients with gastric outlet obstruction (GOO) due to unresectable pancreatic cancers (URPC) include gastrojejunostomy (GJJ) and endoscopic duodenal stent placement (EDSP). This study compared the efficacy and safety of GJJ and EDSP in patients with GOO due to URPC. METHODS: This study retrospectively evaluated consecutive patients with GOO due to URPC who underwent GJJ or EDSP between April 2016 and March 2020. The efficacy and safety of GJJ and EDSP were compared with propensity score analysis. Subgroup analyses of overall survival (OS) were compared after propensity matching. RESULTS: Data were obtained from 54 patients who underwent GJJ and from 73 who underwent EDSP at five tertiary care hospitals. After propensity matching, OS was significantly longer in patients who underwent GJJ than EDSP (110 vs. 63 days, respectively; p = 0.019). Evaluation of long-term adverse events showed that the frequency of cholangitis and obstructive jaundice was significantly lower in the matched GJJ than in the matched EDSP group (p = 0.012). Subgroup analyses showed that OS in patients with good performance status (PS; p = 0.041), biliary obstruction (p = 0.007), and duodenal obstruction near the papilla (p = 0.027), and those receiving chemotherapy (p = 0.010), was significantly longer in the matched GJJ group than in matched EDSP group. CONCLUSION: GJJ provides longer OS than EDSP for patients with GOO caused by URPC, especially for patients with good PS, biliary obstruction, and duodenal obstruction near the papilla, and those receiving chemotherapy.

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.).

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.

Effect of echoendoscope angle on success of guidewire manipulation during endoscopic ultrasound-guided hepaticogastrostomy.

BACKGROUND: With endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), guidewire manipulation might be a critically limiting step for nonexperts. However, the causes of difficult guidewire manipulation remain unclear. The aim of this study was to evaluate factors associated with successful guidewire manipulation. METHODS: This retrospective cohort study included consecutive patients who underwent EUS-HGS between October 2018 and October 2019. We measured scope angle between the long and needle axes of the echoendoscope using still fluoroscopic imaging immediately after puncturing the intrahepatic bile duct. Factors associated with successful guidewire insertion were assessed by multivariable analysis using logistic regression. RESULT: The influence of the angle between the fine-needle aspiration (FNA) needle and echoendoscope on failed guidewire insertion was assessed using receiver operating characteristic (ROC) curves. Area under the ROC curve was 0.86 (95 % confidence interval [CI] 0.00 - 0.76), and an angle of 135° offered 88.0 % sensitivity and 82.9 % specificity for predicting successful guidewire insertion. According to multivariable analysis, only angle between the FNA needle and echoendoscope > 135° was independently associated with successful guidewire insertion (odd ratio 0.03, 95 %CI 0.01 - 0.14; P < 0.05), whereas sex, puncture site, and diameter of puncture site were not significant factors. After multivariable analysis, all variables were adjusted using age ≥ 70 or < 70 years, yielding the same results. CONCLUSION: The angle between the FNA needle and echoendoscope might be associated with successful guidewire manipulation during EUS-HGS. Adjusting this angle to 135° before puncturing the intrahepatic bile duct might be helpful in achieving successful guidewire manipulation during EUS-HGS.

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.

Triple Covered Metal Stent Deployment Using Side-by-Side Technique for Hemobilia due to Hepatocellular Carcinoma (with Video).

A hepatocellular carcinoma (HCC) rarely expands into the biliary tract. In this situation, because of its hypervascular nature, cholangitis or hemobilia may sometimes occur. Surgery is one of the options in this situation. However, patients with HCC and bile duct invasion are sometimes in a poor general condition, as in the case presented in this report. For such patients, surgical treatment may need to be invasive. Thus, here we report technical tips for triple covered metal stent deployment using side-by-side technique for hemobilia due to HCC. After guidewire deployments at the left, anterior, and posterior bile ducts, 6-mm covered self-expandable metal stents were placed at each bile duct. This may be useful for high-grade hepatic hilar obstruction due to HCC because drainage and hemostasis effects are obtained.