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.

Noninvasive endoscopic hemostasis technique for post-papillectomy bleeding using a novel self-assembling peptide (with video).

Although a novel hemostatic agent has been used for endoscopic mucosal resection in submucosal dissection, there are few case reports of its use in pancreato-biliary endoscopic procedures. We describe a case of post-endoscopic papillectomy bleeding in which endoscopic hemostasis was achieved using a novel hemostatic agent.

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.

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.).

Endoscopic ultrasound-guided portal vein coiling: troubleshooting interventional endoscopic ultrasonography.

Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) is widely performed not only as an alternative to transpapillary biliary drainage, but also as primary drainage for malignant biliary obstruction. For anatomical reasons, this technique carries an unavoidable risk of mispuncturing intrahepatic vessels. We report a technique for troubleshooting EUS-guided portal vein coiling to prevent bleeding from the intrahepatic portal vein after mispuncture during interventional EUS. EUS-HGS was planned for a 59-year-old male patient with unresectable pancreatic cancer. The dilated bile duct (lumen diameter, 2.8 mm) was punctured with a 19-gauge needle, and a guidewire was inserted. After bougie dilation, the guidewire was found to be inside the intrahepatic portal vein. Embolizing coils were placed to prevent bleeding. Embolization coils were successfully inserted under stabilization of the catheter using a double-lumen cannula with a guidewire. Following these procedures, the patient was asymptomatic. Computed tomography performed the next day revealed no complications.

Comparison of Endoscopic Hemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique.

Introduction: Recently, a novel self-assembling peptide hemostatic gel has become available in Japan. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after EST. The aim of this study was to evaluate the safety and efficacy of a novel self-assembling peptide hemostatic gel for bleeding after EST, and to perform a comparison to a conventional endoscopic hemostasis technique. Method: This retrospective study was carried out between January 2019 and October 2022. Patients who developed bleeding associated with EST were enrolled. The patients were divided into two groups based on the hemostasis technique used: a conventional hemostasis technique (Group A) or a novel self-assembling peptide hemostatic gel hemostasis technique (Group B). Result: A total of 62 patients (Group A, n = 36; Group B, n = 26) were included. Endoscopic hemostasis was initially obtained in 72.2% (26/32) of patients in Group A and in 88.4% (23/26) of patients in Group B, which was not significantly different (p = 0.1320). However, the procedure time was significantly shorter in Group B (mean, 9.38 min) compared with Group A (mean, 15.4 min) (p = 0.0103). There were no significant differences in the severity of bleeding between the two groups (p = 0.4530). Post-EST bleeding was observed in six patients (Group A, n = 4; Group B, n = 2). Adverse events were more frequently observed in Group A (n = 12) than in Group B (n = 1) (p = 0.0457). Conclusions: PuraStat application for EST bleeding might be safe and effective, and is comparable to the conventional endoscopic hemostasis technique, although further prospective randomized trials are needed.

Can Lemborexant for Insomnia Prevent Delirium in High-Risk Patients with Pancreato-Biliary Disease after Endoscopic Procedures under Deep Sedation?

Background and aim: Pancreato-biliary patients who undergo endoscopic procedures have high potential risk of delirium. Although benzodiazepine has traditionally been used to treat insomnia, this drug might increase delirium. Lemborexant may be useful for patients with insomnia, without worsening delirium, although there is no evidence for high-risk patients with pancreato-biliary disease. The aim of this pilot study was to evaluate the safety and efficacy of lemborexant for insomnia and the frequency of delirium after endoscopic procedures under deep sedation in patients with pancreato-biliary disease. Method: This retrospective study included consecutive patients who were administered lemborexant after endoscopic procedures for pancreato-biliary disease between September 2020 and June 2022. The primary outcome of this study was evaluation of the safety and efficacy of lemborexant for insomnia. Frequency of delirium was the secondary outcome. Result: In total, 64 patients who had the complication of insomnia after an endoscopic procedure were included in the study. Risk factors for delirium were advanced age (n = 36, 56.3%), dementia (n = 10, 15.6%), and regular alcohol use (n = 13, 20.3%), as well as the sedatives midazolam and pentazocine that were administered to all patients at the time of the endoscopic procedure. Successful asleep was achieved by 61/64 patients (95.3%). No fall event was observed during the night following the procedure in any patient. However, mild consciousness transformation was observed in one patient. Conclusions: In conclusion, lemborexant use may be effective and safe for use after endoscopic procedures in pancreato-biliary patients, without increasing the risk of delirium.

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.

Use of double biopsy forceps: A novel technique for safe removal of migrating stent after EUS-guided pancreatic drainage.

Highlight For migrating stent removal, Elshair and colleagues recommend using a double-channel scope and two biopsy forceps. The stent is fixed with one of the forceps and its proximal end is caught with the other while applying countertraction. The proximal end is cut, and the stent is safely removed through the duodenum.

Outcomes of Endoscopic Ultrasound-Guided Biliary Drainage in Patients Undergoing Antithrombotic Therapy.

BACKGROUND/AIMS: The Japan Gastroenterological Endoscopy Society (JGES) has published guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. These guidelines classify endoscopic ultrasound-guided biliary drainage (EUS-BD) as a high-risk procedure. Nevertheless, the bleeding risk of EUS-BD in patients undergoing antithrombotic therapy is uncertain. Therefore, this study aimed to assess the bleeding risk in patients undergoing antithrombotic therapy. METHODS: This single-center retrospective study included 220 consecutive patients who underwent EUS-BD between January 2013 and December 2018. We managed the withdrawal and continuation of antithrombotic agents according to the JGES guidelines. We compared the bleeding event rates among patients who received and those who did not receive antithrombotic agents. RESULTS: A total of 18 patients (8.1%) received antithrombotic agents and 202 patients (91.8%) did not. Three patients experienced bleeding events, with an overall bleeding event rate of 1.3% (3/220): one patient was in the antithrombotic group (5.5%) and two patients were in the non-antithrombotic group (0.9%) (p=0.10). All cases were moderate. The sole thromboembolic event (0.4%) was a cerebral infarction in a patient in the non-antithrombotic group. CONCLUSION: The rate of EUS-BD-related bleeding events was low. Even in patients receiving antithrombotic therapy, the bleeding event rates were not significantly different from those in patients not receiving antithrombotic therapy.

Current status of artificial intelligence analysis for endoscopic ultrasonography.

Endoscopic ultrasonography (EUS) is an essential diagnostic tool for various types of pancreatic diseases such as pancreatic tumors and chronic pancreatitis; however, EUS imaging has low specificity for the diagnosis of pancreatic diseases. Artificial intelligence (AI) is a mathematical prediction technique that automates learning and recognizes patterns in data. This review describes the details and principles of AI and deep learning algorithms. The term AI does not have any definite definition; almost all AI systems fall under narrow AI, which can handle single or limited tasks. Deep learning is based on neural networks, which is a machine learning technique that is widely used in the medical field. Deep learning involves three phases: data collection and annotation, building the deep learning architecture, and training and ability validation. For medical image diagnosis, image classification, object detection, and semantic segmentation are performed. In EUS, AI is used for detecting anatomical features, differential pancreatic tumors, and cysts. For this, conventional machine learning architectures are used, and deep learning architecture has been used in only two reports. Although the diagnostic abilities in these reports were about 85-95%, these were exploratory research and very few reports have included substantial evidence. AI is increasingly being used for medical image diagnosis due to its high performance and will soon become an essential technique for medical diagnosis.

High-Resolution Probe-Based Confocal Laser Endomicroscopy for Diagnosing Biliary Diseases

Probe-based confocal laser endomicroscopy is an endoscopic technique that enables in vivo histological evaluation using fluorescent pigment. The ability to diagnostically differentiate between benign and malignant biliary disease using the “CholangioFlexTM”, a dedicated biliary device, has been reported. However, the Miami and Paris classifications, used as diagnostic criteria, mainly evaluate findings in the submucosa, and visualizing the epithelium as the main site of lesions remains difficult. To address this problem, we verified the imaging findings and diagnostic ability of three types of probes: CholangioFlexTM, GastroFlexTM, and AlveoFlexTM. With GastroFlexTM, the clear mucosal epithelium was observed, and differential diagnoses as benign/malignant could be made based on epithelial findings. GastroFlexTM may be a good first-choice probe for probe-based confocal laser endomicroscopy of biliary diseases, and a new diagnostic classification based on bile duct epithelial findings may provide useful criteria independent of the Miami or Paris classifications.

How to perform EUS-guided hepaticogastrostomy easier and safer.

Highlight Hara and colleagues explain their easier and safer technique of endoscopic ultrasound-guided hepaticogastrostomy using forward-viewing endoscopic ultrasound and ultra-slim devices. The combination of the stiff 0.018-inch guidewire and the 22-gauge needle is helpful for this method.

Single-session multiple stent deployment using moving cell stent without dilating initial stent mesh to treat malignant hilar biliary obstruction (with videos).

BACKGROUND: Malignant hilar biliary obstruction (MHBO) can be treated with bilateral self-expandable metal stents (SEMS) deployed using side-by-side (SBS) or stent-in-stent (SIS) techniques. Moving cell stents (MCS) are a novel type of SEMS. The present study evaluated the technical feasibility of treating MHBO using bilateral novel uncovered SEMS to insert an SIS technique without dilating the mesh of a first stent within a single session. METHOD: We retrospectively assessed patients who were complicated with obstructive jaundice due to MHBO between August and December 2018. Technical success was defined as the deployment of a bilateral MCS into two or more biliary tracts using SIS technique without a dilation device. RESULTS: The present study analyzed data from 23 consecutive patients who were complicated with MHBO. Bilateral SIS technique with MCS was deployed in 22 (95.6%) of the 23 patients without dilating the mesh of the first stent. Multiple guidewire insertion failed in one patient with Bismuth-type IV. The median procedural duration was 33.6 min. Time to recurrent biliary obstruction was 230 days. Severe adverse events were not seen in any patients. CONCLUSION: In conclusion, uncovered moving cell SEMS might facilitate bilateral stent deployment using SIS technique.

Prospective comparison study of franseen needle and standard needle use for pancreatic lesions under EUS guidance.

BACKGROUND AND OBJECTIVES: A needle with Franseen geometry for fine needle aspiration is now available. However, no reports have described prospective evaluations of the Franseen needle or comparisons with the standard needle. The aim of this comparative prospective study was to evaluate the histological diagnostic yield of the Franseen needle and the standard needle using tissue obtained by a single pass of each for the same lesion. PATIENTS AND METHODS: In this study, only tissue obtained by the first pass using the Franseen needle was used. As a comparison group, only tissue obtained from the same lesion by a second pass using the standard needle was used. Evaluation of the histological diagnostic yield of the needles was based on tissue obtained by each single pass with no additional passes. RESULTS: A total of 56 patients were prospectively enrolled. The rate of adequate tissue obtained was significantly higher for the Franseen needle than for the standard needle (89.4% vs. 62.5%, respectively; P < 0.05). The sensitivity and accuracy of the Franseen needle were 80.7%, and 84.6%, respectively, while those for the standard needle were 59.6% and 63.5%, respectively. CONCLUSIONS: The Franseen needle offers a better rate of obtaining adequate tissue and higher diagnostic accuracy than the standard needle.