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.

EUS-Guided Gallbladder Drainage Using an Improved Self-Expandable Covered Metal Stent with Anti-Stent Migration System (with Video).

BACKGROUND: Recently, lumen-apposing metal stents (LAMS) have been developed as novel devices for not only endoscopic ultrasound (EUS)-guided pancreatic fluid drainage but also for EUS-guided gallbladder drainage (GBD). Although LAMS might be clinically impactful, these stents have not yet become available as EUS-GBD stents in all countries, including Japan. Instead, improved metal stents (NEO stents) have become available. The aim of this pilot study was to evaluate the feasibility and safety of EUS-GBD using the improved metal stent with an anti-stent migration system for acute cholecystitis (AC). METHOD: The gallbladder was punctured using a 19-G needle, and a 0.025-inch guidewire was inserted into the gallbladder. After fistula dilation, stent deployment was performed from the gallbladder to the duodenum. Finally, a plastic 7-Fr pigtail stent was placed to prevent stent migration. RESULT: EUS-GBD using NEO stents with the anti-stent migration system was attempted in 12 consecutive patients with AC as a complication of other conditions. EUS-GBD was successfully performed in all patients without any adverse events, and clinical success was achieved in all patients. Median procedure time was 19.0 min (range, 19-24 min). In 4 patients, stent removal was successfully performed after 3 months. Stent migration during follow-up (median, 189 days) was not seen in any of the patients. CONCLUSION: Although this study has several limitations such as small number of patients and short follow-up period, the results show that NEO stents might be suitable as EUS-GBD stents in selected patients. Our results should be validated by a larger prospective, randomized study.

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.

Comparison Study between Double Bare Covered and Fully Covered Metal Stent during Endoscopic Ultrasound-Guided Choledochoduodenostomy (with Video).

BACKGROUND: Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is a common technique for biliary drainage. However, EUS-CDS is associated with adverse events such as cystic duct obstruction, stent dislocation, and stent kinking caused by powerful axial force. A novel double-bare, covered self-expandable metal stent (DBSEMS) has recently become available in Japan. This pilot study evaluated the clinical outcomes of EUS-CDS using DBSEMS. METHOD: We retrospectively enrolled patients with malignant lower bile duct obstruction who underwent EUS-CDS due to failed endoscopic retrograde cholangiopancreatography (ERCP). EUS-CDS procedures performed between April 2017 and March 2018 used a conventional fully covered self-expandable metal stent (FCSEMS), and those performed between April 2018 and April 2019 used DBSEMS. In all stents, the diameter was 10 mm and length was 6 cm. RESULTS: A total of 22 patients underwent EUS-CDS, performed using conventional FCSEMS (n = 12) and DBSEMS (n = 10). Four complications occurred with FCSEMS: cholangitis due to kinking (n = 3) and stent dislocation (n = 1). With DBSEMS, there were no instances of kinking, and reflux cholangitis that developed in 1 patient due to duodenal obstruction was resolved by duodenal stenting. Elapsed time to recurrent biliary obstruction was longer with DBSEMS than FCSEMS (200 vs. 99 days), although the difference was not significant (p = 0.06). CONCLUSION: BSEMS can help prevent cholangitis due to stent kinking after EUS-CDS, thus increasing stent patency.

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.

Risk factors for adverse events associated with bile leak during EUS-guided hepaticogastrostomy.

BACKGROUND AND OBJECTIVE: EUS-guided hepaticogastrostomy (HGS) is performed for patients with advanced cancer because of poor prognosis and compromised status, and bile peritonitis may prove critical for such patients. This adverse event has the possibility of decreasing quality of life by prolonging the time until the start of oral intake, hospital stay, or chemotherapy. Predictors of bile peritonitis in EUS-HGS thus have considerable clinical impact. The aim of this study was to retrospectively determine risk factors of bile peritonitis as adverse events of EUS-HGS. PATIENTS AND METHODS: As risk factors of bile peritonitis, baseline characteristics of patients, characteristics of procedures such as number of punctures, types of fistula dilation, mean procedure time were analyzed. Furthermore, a receiver operating characteristic (ROC) curve was plotted to assess the influence of this distance and bile peritonitis and determine the optimum cutoff score for predicting the risk of bile peritonitis. Multivariate analysis using logistic regression was performed to examine factors of bile peritonitis. RESULTS: A total of 68 patients were enrolled in this study. A distance of 2.50 cm offered 90.3% sensitivity and 87.5% specificity in predicting bile peritonitis according to the ROC curve. Number of punctures (>1), procedure time (>20 min), distance to the hepatic parenchyma (<2.50 cm), and presence of acute cholangitis were significantly associated with bile peritonitis in univariate analysis. However, according to this multivariate analysis, distance to the hepatic parenchyma (<2.50 cm, odds ratio 96.98, 95% confidence interval 10.12-929.12, P < 0.001) were only significantly associated with bile peritonitis. CONCLUSIONS: The short distance of hepatic parenchyma may be a risk factor of bile peritonitis.

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.

Multicenter clinical experience with recombinant soluble thrombomodulin for disseminated intravascular coagulation associated with severe acute cholecystitis.

BACKGROUND: Severe acute cholecystitis (AC) is defined by the association of organ dysfunction, including hematological dysfunction, with AC. Severe AC is often complicated by disseminated intravascular coagulation (DIC), the diagnostic criteria of which overlap with AC-associated hematological dysfunction. Since the diagnosis of DIC often delays definitive surgical management of severe AC, treatment of DIC in this setting is clinically important. Recombinant human soluble thrombomodulin (rTM) is a new agent that has proven clinically useful for treating DIC. However, the relevance of rTM to sepsis-induced DIC caused by AC has not been clinically evaluated. This retrospective multicenter study aimed to determine the clinical impact of rTM on sepsis-induced DIC caused by AC. METHODS: This retrospective multicenter study initially included 68 consecutive patients and proceeded between July 2014 and December 2017. The inclusion criterion was sepsis-induced DIC caused by severe AC due to benign disease. Sixteen of the 68 patients were excluded in this study due to having advanced malignant tumors. Finally, 42 patients were enrolled in this study. We treated DIC with AC using Recomodulin® Injection (rTM) at doses of 130 or 380 U/kg/day. RESULTS: 17 and 25 patients were treated with and without rTM, respectively. Values on days 3 and 7 did not significantly differ between the groups for PT-INR (P = 0.38 and P = 0.16, respectively) and FDP (P = 0.06 and P = 0.08, respectively), and PLT was significantly increased in the rTM group at day 7 (P = 0.03). Resolution rates of DIC on day 7 were significantly higher in the group treated with, than without rTM (94.1% [16/17] vs. 68.0% [17/25], P = 0.04). Two patients in each group died of sepsis-induced DIC associated with severe AC, and thus mortality rates did not significantly differ. CONCLUSIONS: rTM can may be improve the resolution rate of sepsis-induced DIC due to severe AC. Future studies should include more patients to validate our findings.

EUS-Guided Antegrade Biliary Stenting Using a Novel Fully Covered Metal Stent (with Video).

BACKGROUND: Recently, endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) combined with antegrade stenting (AS) has been reported to be associated with longer stent patency and reduced procedure-related adverse events. In EUS-AS, an uncovered metal stent is usually selected to prevent stent misplacement or dislocation. However, because patient survival has improved with advances in chemotherapy, longer stent patency may be required. AIM: The technical feasibility and safety of EUS-guided transhepatic biliary drainage combined with EUS-AS using a novel covered metal stent were evaluated. METHODS: Patients with malignant biliary obstruction leading to obstructive jaundice, in whom standard ERCP had failed or was contraindicated, were enrolled in this study between July 2015 and October 2017. As the control group, patients undergoing EUS-AS using an uncovered metal stent were enrolled between October 2014 and June 2015. RESULTS: A total of 39 patients were enrolled in this study. Among them, EUS-AS using a covered metal stent was performed in 17 patients and using an uncovered metal stent in the remaining 22 patients. Median stent patency including stent dysfunction and patient death was longer in the covered metal stent group (153 days) compared with that of the uncovered metal stent group (108 days) although there were no significant differences (P = 0.06). In only cases with stent dysfunction was median stent patency of the covered metal stent group significantly longer than that of the uncovered metal stent group (not available vs 150 days, P = 0.02). CONCLUSIONS: In conclusion, EUS-guided transluminal biliary drainage combined with EUS-AS using a covered metal stent may be feasible and safe, although the indications for this procedure should be carefully considered.

Pilot Study of Dumbbell-Type Covered Self-Expandable Metal Stent Deployment for Benign Pancreatic Duct Stricture (with Videos).

BACKGROUND: Fully-covered, self-expandable metal stents (FCSEMS) have been deployed to treat symptomatic chronic pancreatitis (CP) complicated with main pancreatic duct (MPD) stricture. Although this strategy can be effective, it has the disadvantages of stent migration or stent-induced ductal change. Removal of an FCSEMS can also be challenging in the face of distal migration because of MPD stricture. Dumbbell-type FCSEMS have been developed to prevent stent-induced ductal changes and improve removability when treating benign biliary stricture. This stent might also confer clinical benefits upon patients with MPD stricture. AIMS: The present pilot study aimed to determine the feasibility and safety of deploying dumbbell-type FCSEMS in patients with CP complicated by MPD stricture. METHOD: Stents were deployed in 22 patients with MPD stricture caused by CP and complicated by abdominal pain. RESULTS: Strictures were located at the head (n = 19), body (n = 2), and head and tail (n = 1) of the MPD. Stents were deployed above the papilla in three patients. All stents were deployed for a median duration of 142 (range, 49-190) days and removed. The resolution of MPD strictures was confirmed by pancreatography in 19 (86.3%) patients. Two metal stents that spontaneously tore during removal from two patients had otherwise functioned normally. Only three patients developed recurrent MPD stricture during a median follow-up of 419 (range, 261-484) days.. CONCLUSIONS: Deployment of a dumbbell-type FCSEMS seems feasible for MPD stricture, and the rate of adverse events is acceptable.

A case of adenocarcinoma developed in the small intestine with chronic strongyloidiasis.

We experienced a case of intestinal strongyloidiasis complicated by jejunal carcinoma. A Japanese male in his 50s, who has a 7-year medical history of duodenal ulcers, complained of loss of appetite, nausea, vomiting and diarrhea. Computed tomography and gastroduodenal endoscopic examination revealed a stenosis of the duodenum. To remove the stenosis, gastric bypass surgery was performed. The pathological diagnosis of the resected jejunum was strongyloidiasis and well-differentiated adenocarcinoma with subserosal invasion and vascular infiltration. After administration of Ivermectin, Strongyloides stercoralis was not found in any biopsies or in the specimens of the intestine, which were resected due to cancer recurrence 2 years later. There are three possibilities for the reason of coexistence of S. stercoralis and adenocarcinoma: S. stercoralis caused the adenocarcinoma, S. stercoralis moved to the carcinoma, or just coincidence. Although it is difficult to prove a causal relationship between S. stercoralis and adenocarcinoma, this is the first report of adenocarcinoma developed in the jejunum with chronic strongyloidiasis. The number of nematode infections, including strongyloidiasis, is decreasing in Japan, although not worldwide. Therefore, it should be considered in patients with prolonged intestinal ulcers.

Prospective evaluation of digital single-operator cholangioscope for diagnostic and therapeutic procedures (with videos).

BACKGROUND AND AIM: Recently, the digital single-operator cholangioscope (SPY-DS) has become available. This system may allow diagnosis by direct visualization and allow performance of various therapeutic procedures. The aim of the present study was to prospectively evaluate the clinical utility of DSOCS for diagnostic and therapeutic procedures for biliary disease. METHODS: Technical success was defined as successful visualization of target lesions in the biliary tract and carrying out forceps biopsy as a diagnostic procedure, and successfully carrying out treatment such as guidewire insertion for the area of interest, electrohydraulic lithotripsy (EHL), or migrated stent removal. Also, the present study aimed at investigating diagnostic yield of the cholangioscopic findings and biopsy specimens. RESULTS: A total of 55 consecutive patients were prospectively enrolled in this study; a diagnostic procedure was done in 33 patients, and a therapeutic procedure was done in 22 patients. Overall accuracy of visual findings was 93%, with a sensitivity of 83%, a specificity of 89%, positive predictive value (PPV) of 83%, and negative predictive value (NPV) of 100%. However, the overall accuracy of forceps biopsy was 89%, with a sensitivity, specificity, and PPV of 100%, and NPV of 90%. Overall technical success rate of therapeutic procedures such as selective guidewire insertion, EHL or migrated stent removal was 91% (20/22). Finally, adverse events were seen in two cases in the diagnostic group, but were not seen in the therapeutic group. CONCLUSION: Although additional cases and a randomized, controlled study with another cholangioscope are needed, diagnostic and therapeutic procedures using SPY-DS appear to be feasible and safe.