Prospective registration study of diagnostic yield and sample size in forceps biopsy using a novel device under digital cholangioscopy guidance with macroscopic on-site evaluation.

BACKGROUND: Although the SpyGlass Direct Visualization System can be clinically useful for diagnosing indeterminate biliary stricture, it employs SpyBite forceps, which typically obtain only a small amount of tissue and have a low sampling rate. An improved forceps biopsy device for SpyGlass DS has recently been released (SpyBite MAX). The aim of this prospective registration study was to assess the diagnostic yield and efficacy of histological biopsy tissue obtained with SpyBite MAX forceps compared with SpyBite forceps in patients with indeterminate biliary stricture. METHODS: The primary outcome of the study was the diagnostic accuracy of biopsy specimens obtained by SpyBite MAX forceps. The secondary outcomes were tissue size, number of forceps biopsies, rate of obtaining adequate tissue, and adverse events in the SpyBite MAX forceps group compared with the SpyBite group. RESULTS: Forceps biopsies using SpyBite MAX (n = 47) and SpyBite (n = 50) were performed successfully in all patients. The number of biopsies performed before visible core tissue was obtained was significantly lower in the SpyBite (mean, 1.5 ± 0.7) than in the SpyBite forceps group (mean, 2.3 ± 1.1 mm; P < .001). Tissue sample size was larger in the SpyBite MAX group (mean, 1.8 ± 1.6 mm2 ) than in the SpyBite group (mean, 1.0 ± 0.9 mm2 ; P = .004) but there was no significant difference in diagnostic accuracy. CONCLUSION: Improvements in dedicated forceps for biopsy in SpyGlass DS may contribute to improving the rates of adequate tissue and tissue sample size obtained, and to reducing the number of forceps biopsies required.

Endoscopic bilateral revision after metal stent deployment for hepatic hilar obstruction using molting technique (with videos).

Background: After multiple uncovered self-expandable metal stent (UCSEMS) deployments, endoscopic revision becomes complex and potentially challenging. A novel stent delivery system with a dilation function has recently been developed in Japan. This study evaluated the technical feasibility of this device for patients with unresectable malignant hilar biliary obstruction (MHO) after multiple UCSEMS deployments. Method: Participants comprised consecutive patients with unresectable MHO who had undergone multiple UCSEMS deployments and required endoscopic revision for the right or left hepatic bile ducts, as decided by cholangiography under endoscopic retrograde cholangiopancreatography (ERCP) guidance. Results: A total of 14 patients requiring endoscopic revision of right and left hepatic bile ducts were enrolled in this study. Among these 14 patients, guidewire insertion through the mesh of previously placed stents failed in 2 patients. As a result, these two patients underwent only unilateral UCSEMS deployment. Because clinical success was not obtained, transmural placement of the UCSEMS under Endoscopic Ultrasound (EUS) guidance to the segment of the liver not being drained was performed in those patients. The molting technique was attempted in 12 patients, proving successful in all patients. The technical success rate was therefore 92.8% (12/14). Mean procedure time was 23.2 min. Conclusion: This novel stent delivery system with a dilation function may be useful in endoscopic revision techniques for bilateral UCSEMS deployment.

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.).

Partially covered self-expandable metal stent with antimigratory single flange plays important role during EUS-guided hepaticogastrostomy.

Background and study aims Stent migration into the abdominal cavity, which can occur due to stent shortening or stomach mobility, is a critical adverse event (AE) in EUS-HGS. To prevent this AE due to stent shortening, a novel, partially covered self-expandable metal stent with an antimigratory single flange has recently become available in Japan. The present study evaluated the clinical feasibility and safety of EUS-HGS using this novel stent. Patients and methods We measured stent length in the abdominal cavity and the luminal portion after EUS-HGS using computed tomography (CT) performed 1 day after EUS-HGS (early phase). To evaluate stent shortening and the influence of stomach mobility, we also measured stent length at the same sites on CT performed at least 7 days after EUS-HGS (late phase). Results Thirty-one patients successfully underwent EUS-HGS using this stent. According to CT in the early phase, stent length in the abdominal cavity was 7.13 ±â€Š2.11 mm and the length of the luminal portion was 53.3 ±â€Š6.27 mm. Conversely, according to CT in the late phase, stent length in the abdominal cavity was 8.55 ±â€Š2.36 mm and the length of the luminal portion was 50.0 ±â€Š8.36 mm. Stent shortening in the luminal portion was significantly greater in the late phase than in the early phase ( P  = 0.04). Conclusions CT showed that stent migration can occur even with successful stent deployment, due to various factors such as stent shortening. The antimigratory single flange may be helpful to prevent stent migration, but further prospective comparative studies are needed to confirm our results.

Prospective multicenter evaluation of moving cell metallic stents in endoscopic multiple stent deployment for hepatic hilar obstruction.

BACKGROUND AND AIM: Bilateral stent deployment for malignant biliary obstruction (MHBO) can be achieved using side-by-side (SBS) or stent-in-stent (SIS) procedures. Compared with SBS techniques, the procedural steps of SIS are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the SEMS. To overcome this issue, a novel uncovered SEMS, the HILZO Moving Cell Stent (MCS) has been released. The present study examined the technical feasibility of treating MHBO using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting. METHOD: The primary outcome in the present study was the technical success rate. Technical success was defined as deployment of bilateral MCSs into two or more biliary tracts using SIS without a dilation device in a single-session. RESULTS: A total of 27 patients with complications of MHBO were enrolled in this study. Bilateral SIS using two MCS was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%). Median time to recurrent biliary obstruction (TRBO) was 271 days. Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care. CONCLUSIONS: The SIS technique using MCS without dilation of the mesh may be technically feasible and safe. In addition, this may be useful for re-intervention. Further comparative randomized trials are needed.

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.

Endoscopic gallbladder drainage for acute cholecystitis with high-risk surgical patients between transduodenal and transpapillary stenting.

BACKGROUND AND OBJECTIVES: EUS-guided gallbladder drainage (GBD) has emerged as an alternative GBD technique, particularly for high-risk surgical patients. To prevent stent migration or to facilitate stent deployment, the lumen-apposing metal stent (LAMS) was recently developed for EUS-GBD. However, LAMS remains unavailable in several countries and is expensive compared with conventional fully covered self-expandable metal stent (FCSEMS). Although several studies have shown the clinical benefits of EUS-GBD using novel FCSEMS or LAMS compared with endoscopic transpapillary GBD (ETGBD), the choice between ETGBD and EUS-GBD using conventional FCSEMS and ETGBD remains controversial. The aim of this study was to evaluate EUS-GBD using conventional FCSEMS compared with ETGBD. Materials and Methods: This comparative retrospective study included consecutive symptomatic AC patients who underwent gallbladder drainage by either EUS-GBD or ETGBD between January 2015 and December 2018.The main outcome measures were technical success, clinical success, procedure-related and stent-related adverse events, and recurrence of AC during follow-up. RESULTS: Fifty-four patients (44.4% female, 55.6% male) who underwent EUS-GBD (n = 25) or ETGBD (n = 29) were enrolled. Initial technical success rates were 100% with EUS-GBD and 82.7% (24/29) with ETGBD. The median procedure time was significantly shorter for the EUS-GBD group than for the ETGBD group (11.0 vs. 24.0 min, P < 0.05). Procedure-related adverse events did not differ significantly between groups (P = 0.283). During follow-up (median 522 days, range 43 - 1892 days), recurrent acute cholecystitis (AC) was only observed in 4 patients from the ETGBD group. Overall survival did not differ significantly between the EUS-GBD group (mean 1070 days) and ETGBD group (mean 1470 days) (P = 0.292). CONCLUSION: The technical success rate for EUS-GBD using FCSEMS with plastic stent insertion was significantly higher with a shorter procedure time and resulted in a lower rate of recurrent AC.

Technical feasibility and safety of one-step deployment of EUS-guided hepaticogastrostomy using an 8-mm diameter metal stent with a fine-gauge stent delivery system (with video).

BACKGROUND AND OBJECTIVES: Adverse events (AEs) such as bile peritonitis or pneumoperitoneum might occur during procedural steps for EUS-guided hepaticogastrostomy (HGS), such as during device exchange and after fistula dilation until stent deployment. Reducing the steps to the EUS-HGS procedure might therefore be ideal to prevent the occurrence of AEs. Recently, a novel, fully covered self-expandable metal stent (FCSEMS) has become available. Because of the fine-gauge stent delivery system (5.9Fr), fistula dilation might not be needed before stent deployment during EUS-HGS. The aim of this pilot study was to evaluate the technical feasibility and safety of one-step EUS-HGS using a novel 8-mm diameter FCSEMS. PATIENTS AND METHODS: The primary outcome in this study was technical success, and the secondary outcomes were procedure- and stent-related AEs and clinical success. The technical success of one-step EUS-HGS was defined as successful FCSEMS deployment without any fistula dilation. Procedure time was measured from scope insertion to successful FCSEMS deployment. RESULTS: One-step EUS-HGS using the novel FCSEMS was attempted on 14 patients. Technical success with a short procedure time (median: 7 min) and clinical success were obtained in all patients. In addition, procedure-related AEs such as bleeding, bile peritonitis, and stent migration during the procedure were not observed in any patients. CONCLUSIONS: One-step EUS-HGS using the novel FCSEMS with a fine-gauge stent delivery system is technically feasible and shortens the procedure time with no requirement for additional fistula dilation, resulting in a potential reduction in procedure-related AEs.

Clinical evaluation of physician-controlled guidewire manipulation during endoscopic ultrasound-guided hepaticogastrostomy (with video).

Background and study aims Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) may be most complex because of the EUS-guided biliary drainage procedure and variations in the course of the intrahepatic bile duct compared with the common bile duct (CBD). Appropriate guidewire insertion is essential. Physician-controlled guidewire manipulation (PCGW) might improve technical success rates of bile duct cannulation. The present study aimed to determine the technical feasibility and safety of PCGW during EUS-HGS. Patients and methods A total of 122 consecutive patients who were scheduled to undergo EUS-HGS between October 2017 and April 2019 were prospectively registered. The primary endpoint was the technical success rate of guidewire insertion into the CBD or hepatic hilum. Guidewire insertion was considered to have failed if the HGS assistant failed to achieve manipulation. Results The intrahepatic bile duct was successfully punctured in 120 of 122 patients. During guidewire insertion by the HGS assistant, guidewire fracture was observed in one patient. The guidewire was successfully inserted into the biliary tract and manipulated by the HGS assistant in 96 patients. PCGW was thus attempted for the remaining 23 patients. The guidewire was inserted by PCGW in all 23 patients, improving the technical success rate for guidewire insertion from 80 % to 100 %. After tract dilation, we deployed covered metal stents and plastic stents in 117 and two patients, respectively. The overall technical success rate for EUS-HGS was 97.5 % (119/122). Adverse events comprising bile peritonitis or leakage developed in five patients. Conclusion PCGW might contribute to improving the success rate of EUS-HGS.

Experimental study of loop shape using 0.025-inch ERCP guidewires (with videos).

Background and study aims Duct penetration by the guidewire sometimes occurs during endoscopic retrograde cholangiography, which might lead to adverse events such as acute pancreatitis. To prevent duct penetration, making a loop shape with the guidewire might provide a useful technique. The aim of this experimental study was thus to evaluate which types of guidewire can most easily form a loop shape. Methods This experimental study evaluated six guidewires (0.025-inch, angle type): MICHISUJI; VisiGlide 2; Jagwire; Pathcorse; RevoWave-α UltraHard 2; and M-through. Flexibility of the tip, shaft stiffness, and the ability to form a loop were evaluated for each type in an ex vivo model. Deformation behavior was also recorded on video, and factors suitable for making a loop shape in each guidewire were evaluated. Results Flexibility and stiffness of each guidewire differed significantly. During an experimental study regrading deformation behavior before forming a loop shape, maximum load was lower for MICHISUJI (6.8 g) than for other guidewires (Jagwire [11.3 g], M-through [12.9 g], VisiGlide 2 [12.9 g], Revowave [21 g], and Pathcorse [25.4 g]). Mean time required to achieve a loop shape was as follows: MICHISUJI, 6.2 seconds; M-through, 8.7 seconds; VisiGlide 2, 11.0 seconds; and Revowave, 7.1 seconds. Conclusion In conclusion, characteristics of flexibility and stiffness among guidewires were significantly different in the ex-vivo study. In the experimental study regrading deformation behavior until achieving a loop shape, maximum load also differed. To evaluate whether guidewires easily form a loop shape, clinical study is needed.

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.

Technical feasibility and safety of transluminal antegrade dilation for hepaticojejunostomy stricture using a novel fine-gauge electrocautery dilator (with video).

Background and study aims A novel fine-gauge electrocautery dilator (ED) has recently become available in Japan. The current study evaluated the safety and feasibility of transluminal antegrade dilation for hepaticojejunal stricture (HJS) using this novel ED. Patients and methods Patients who with complicated HJS were retrospectively enrolled. The primary and secondary endpoints of this study were rates of technical success defined as functional antegrade HJS dilation using the novel ED and types of adverse events, respectively. A total of 22 patients were enrolled. Among them, six were treated using an enteroscopic approach due to the absence of bile duct dilation or patient refusal to undergo EUS-HGS. Therefore, 16 patients underwent EUS-HGS. Results The procedure was successful in 15 of 16 patients (93.8 %). The contrast medium flowed from the intrahepatic bile duct to the intestine of 14 of 15 patients (93.3 %). The resolution rate of HJS was 13 of 14 (92.9 %) at 6 months. Conclusion Our technique might offer a new option with which to treat HJS, although a prospective study with long-term follow-up is needed.

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.

Technical feasibility of EUS-guided antegrade dilation for hepaticojejunostomy anastomotic stricture using novel endoscopic device (with videos).

Background: A novel endoscopic dilation device (EZ Dilator; Zeon Medical Co, Tokyo, Japan) is now available in Japan that might affect dilation for biliary strictures under endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) guidance because it has good push ability. We evaluated the technical feasibility of this device under EUS guidance in a case series of patients with hepaticojejunostomy anastomotic stricture (HJAS) that led to further complications. Method: We enrolled 14 patients with HJAS leading to obstructive jaundice or repeated cholangitis in this study. Technical success was defined as insertion of the EZ Dilator into the intestine across the stricture site without the need for other dilation devices. Deployed plastic stents were removed after three months to evaluate anastomosis sites. Results: The median procedural duration was 25 minutes. Rates of technical and clinical success were 100% and 78.5%, respectively. One patient developed an adverse event of abdominal pain. Contrast medium flowed across the anastomosis site in 11 patients after stent removal, indicating a clinical success rate of 78.5% (11 of 14). Plastic stents were deployed again in the remaining three patients. Conclusion: Although a prospective evaluation with long-term follow up is needed, the EZ Dilator shows clinical promise for treating benign biliary strictures under ERCP and EUS guidance.