Long-term outcomes after EUS-guided antegrade intervention for benign bilioenteric anastomotic stricture.

BACKGROUND AND AIMS: Bilioenteric anastomotic stricture (BES) is a well-known adverse event after bilioenterostomy. Recently, EUS-guided antegrade intervention (EUS-AI) has been developed for cases that are difficult to treat by balloon enteroscopy-assisted ERCP. However, no data are available on the long-term outcomes after EUS-AI. The main goal of the present study was to clarify the long-term outcomes of EUS-AI in such patients. METHODS: Between November 2013 and November 2021, 34 patients who were followed for more than 1 year after EUS-AI for BES were identified. The primary endpoint was the rate of stricture resolution. Secondary endpoints were factors associated with stricture resolution, rate of BES recurrence, rate of conversion to surgery, and rate of hepatic fibrosis progression during follow-up. RESULTS: The median follow-up period was 56.7 months. Stricture resolution was achieved in 17 of 34 patients (50%). A multivariate analysis confirmed that the presence of bile duct stones (odds ratio, 9.473; 95% confidence interval, 1.66-53.98; P = .01) was significantly associated with stricture resolution. The stricture recurrence rate was 33%, and the median time from stent removal to recurrence was 31.2 months. Four patients underwent surgery because of recurrent cholangitis. During the median follow-up period of 56.7 months, 25% progressed to hepatic fibrosis based on the Fibrosis-4 index grade. Interestingly, patients without cholangitis during follow-up did not show progression of hepatic fibrosis. CONCLUSIONS: EUS-AI has achieved acceptable long-term clinical outcomes. EUS-AI can be a viable alternative treatment of choice before surgical treatment in patients who are difficult to treat by conventional approaches.

Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

BACKGROUND AND AIMS: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. METHODS: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. RESULTS: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). CONCLUSIONS: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.).

Optimal mode and power output of electrosurgical units for endoscopic papillectomy based on animal experiments and a preliminary clinical study (with videos).

BACKGROUND AND AIMS: The optimal electrosurgical unit (ESU) settings for endoscopic papillectomy (EP) have not been investigated. We conducted animal experiments to determine the optimal endoCUT settings with VIO (Erbe, Tübingen, Germany) ESUs and then conducted a small clinical study. METHODS: Dedicated animal experimental models were created. To investigate the incision force, chicken meat was resected with a snare whose handle was a hung weight. To investigate the coagulation effect, a surgical needle electrode was inserted into a pig liver and energized, and to determine changes over time in the coagulation status, simulated EP was performed using a living pig. These experiments were performed using the knife-setting or snare-setting endoCUT modes and various effect, duration, and interval settings and compared with results for ICC (Erbe) ESUs. Based on the results, we performed EP in a small number of patients. RESULTS: The main factor affecting the incision force was duration. The coagulation effect was related to not only effect but also duration. In the endoCUT mode, knife-setting produced a higher incision force and lower coagulation effect. The nondischarge coagulation effect may cause deep ulceration. Based on the animal experiments, we concluded the ideal ESU setting for EP, "VIO EP mode," is knife-setting with high duration, lowest effect, and low interval settings. In the clinical study, there were no significant adverse events such as bleeding, pancreatitis, or perforation. CONCLUSIONS: "VIO EP mode" seems to afford optimal papillectomy. Larger scale clinical studies are needed to accumulate further data and make clinical comparisons with the ICC ESU.

Ex vivo assessment of anchoring force of covered biflanged metal stent and covered self-expandable metal stent for interventional endoscopic ultrasound.

BACKGROUND AND AIMS: Endoscopic ultrasound (EUS)-guided transmural drainage using a covered biflanged metal stent (CBFMS) and a conventional tubular biliary covered self-expandable metal stent (CSEMS) has recently been performed by EUS experts. However, appropriate traction force of the sheath to prevent the migration during stent deployment is well unknown. Herein, we assessed the anchoring force (AF) of the distal flange in CBFMSs and CSEMSs. METHODS: The AFs of four CBFMSs (Stents AX, NG, PL, and SX) and six CSEMSs (Stents BF, BP, EG, HN, SP, and WF) were compared in an ex vivo setting. We assessed the AF produced by each stent using an EUS-guided transmural drainage model and an EUS-guided hepaticogastrostomy model consisting of sheet-shaped specimens of the stomach, gelatin gel, and gelatin tubes. RESULTS: For CBFMSs, the maximum AF of Stent AX was significantly higher than those of Stents PL and SX (P < 0.05) in the porcine model. In the gelatin series, all stents except Stent NG showed a nearly similar AF. For CSEMSs, Stents HN, EG, BF, and WF showed gradual AF elevation in the porcine stomach. Stents SP and BP showed a lower AF than the other four stents. For the gelatin setting, the maximum AF of Stents HN, EG, and WF was higher than those of the other stents regardless of the type of specimens. CONCLUSIONS: The significance of the AF and traction distance according to the property of various CBFMSs and CSEMSs could be elucidated using ex vivo models.

Expanding the indication of endoscopic papillectomy for T1a ampullary carcinoma.

BACKGROUND AND AIM: Endoscopic papillectomy (EP) has been attempted not only for benign lesions but also for early ampullary carcinoma (AC). However, there is still no sufficient evidence or consensus regarding the effectiveness of EP for early AC. Herein, we evaluated the expanding indication of EP for early AC. METHODS: Between May 1999 and December 2016, 177 patients were diagnosed with ampullary tumor before undergoing EP, and their clinical and histopathological data were analyzed retrospectively. RESULTS: There were 27 Tis-T1a AC patients and four T1b AC patients who underwent EP. Mean tumor size was 14.1 mm for Tis-T1a AC and 17.0 mm for T1b AC. For the histological grade, 50% (2/4) of T1b AC were moderately differentiated, whereas 96.3% (26/27) of Tis-T1a AC were well differentiated and papillary. For lymphovascular invasion, one (25%) occurred in T1b AC but none occurred in Tis-T1a AC. There was no AC recurrence from the date of EP until a maximum of 5 years (Tis-T1a: mean period 48.5 months [5-60]; T1b: mean period 26.5 months [3-60]). CONCLUSIONS: Endoscopic papillectomy is useful and reliable for the curative treatment of T1a AC. Large-scale prospective studies with long-term follow up are needed.

Novel ex vivo training model for freehand insertion using a double-bending peroral direct cholangioscope.

BACKGROUND AND AIM: Several experts of direct peroral videocholangioscopy (D-PVCS) using a conventional ultraslim endoscope have reported its usefulness for the diagnosis and therapy of biliary tract diseases. We have additionally developed a dedicated double-bending D-PVCS technique for freehand scope insertion. In this study, we developed an ex vivo training model for the freehand double-bending D-PVCS technique and compared it with the technique using a conventional ultraslim endoscope. METHODS: The ex vivo model was made for training using a U-shape insertion pattern. A third prototype endoscope and an ultraslim upper gastrointestinal endoscope were used. Two experts and nine non-experts performed D-PVCS using the freehand technique. RESULTS: The two experts could not advance the tip of the endoscope to the hilar portion using the freehand technique, but they could achieve technical successful insertion to the hilar portion with the third prototype cholangioscope using the freehand technique alone. The non-experts could not advance the tip of the endoscope to the bile duct using the freehand technique. On the other hand, two (22.2%) non-experts could advance the tip of the third prototype cholangioscope using the freehand technique before the training conducted by the experts. After the training, all the non-experts could advance the tip of the third prototype cholangioscope to the hilar portion. CONCLUSIONS: The novel ex vivo model using a third prototype cholangioscope was useful for training in the use of the freehand D-PVCS technique.

Endoscopic management of acute cholangitis according to the TG13.

The Tokyo Guidelines 2013 (TG13) recommend that endoscopic drainage should be the first-choice treatment for biliary decompression in patients with acute cholangitis. Timing of biliary drainage for acute cholangitis should be based on the severity of the disease. For patients with severe acute cholangitis, appropriate organ support and urgent biliary drainage are needed. For patients with moderate acute cholangitis, early biliary drainage is needed. For patients with mild acute cholangitis, biliary drainage is needed when initial treatment such as antimicrobial therapy is ineffective. There are three methods of biliary drainage: endoscopic drainage, percutaneous transhepatic drainage, and surgical drainage. Endoscopic drainage is less invasive than the other two drainage methods. The drainage method (endoscopic nasobiliary drainage and stenting) depends on the endoscopist's preference but endoscopic sphincterotomy should be selected rather than endoscopic papillary balloon dilation from the aspect of procedure-related complications. In the TG13, balloon enteroscopy-assisted and endoscopic ultrasound-guided biliary drainages have been newly added as specific drainage methods. Recent studies have demonstrated their usefulness and safety. These drainage methods will become more widespread in the future.

Potential versatile uses of a novel ultra-thin peroral cholangioscope.

Tonozuka and colleagues report the usefulness of a newly developed ultra-thin mother-baby type peroral cholangioscope with a tip external diameter of 2.3 mm for a case of biliary stricture in which conventional peroral cholangioscope insertion was challenging. The novel scope allows simple and low-cost peroral cholangioscopy, making it highly versatile.

Early and late effects of endoscopic interventions in patients with malignant afferent loop syndrome: A single-center experience and literature review.

BACKGROUND/PURPOSE: Afferent loop syndrome (ALS) is a rare adverse event after gastrointestinal surgery requiring appropriate early decompression treatment. Several endoscopic interventions have been attempted for treatment, including endoscopic enteral metal stent placement (EMSP), endoscopic ultrasound (EUS)-guided entero-enterostomy (EUS-EE), and EUS-guided hepaticogastrostomy (EUS-HGS). However, there are limited data on outcomes, including duration of stent patency. In this study, we evaluated the usefulness of each endoscopic intervention for malignant ALS. METHODS: We retrospectively investigated nine patients with malignant ALS who underwent EMSP, EUS-EE, or EUS-HGS. Information on technical success, clinical efficacy, adverse events, stent dysfunction, and overall survival was collected and analyzed. RESULTS: The most common symptoms were abdominal pain and cholangitis. ALS was treated by EMSP in three patients, EUS-EE in three patients, and EUS-HGS in three patients. Stent placement was successful and clinically effective in all patients with no adverse events. During follow-up, stent dysfunction occurred in two patients treated by EUS-HGS. Eight patients died of primary disease during a median follow-up of 157 days. CONCLUSIONS: Each of the available endoscopic interventions for malignant ALS can be expected to produce similar outcomes, including duration of stent patency. The choice of endoscopic intervention should be made based on the characteristics of each treatment.

A novel technique for one-step dilation followed by bile aspiration using an ultra-tapered bougie dilator with side holes to minimize bile leakage during EUS-guided hepaticogastrostomy.

Bile aspiration during endoscopic ultrasound-guided hepaticogastrostomy reduces the risk of bile leakage. Mukai and colleagues devised a method in which side holes for bile aspiration are created using a biopsy punch in a hard type ultra-tapered bougie dilator. Effective bile aspiration was achieved in all four cases attempted.

A novel self-assembling hemostatic agent as an effective therapeutic tool for intracavitary bleeding from peripancreatic fluid collection after endoscopic ultrasonography-guided drainage using a lumen-apposing metal stent.

EUS-guided drainage using a lumen-apposing metal stent (LAMS) has demonstrated promising clinical efficacy for peripancreatic fluid collection. However, intracavitary bleeding has been reported after LAMS placement. Yamamoto et al. reported endoscopic hemostasis using hemostatic gel for intracavitary bleeding.

A novel tube placement technique in EUS-guided drainage for small pancreatic pseudocyst: Spinning lasso method.

This paper discusses a novel tube placement technique; the "spinning lasso method", in EUS-guided drainage for small pancreatic pseudocysts (PC) with video. In general, the placement of a drainage tube can be difficult in a small PC and the tube often deviates during attempted insertions into the cavity. The technique helps to mitigate this problem.

Endoscopic retrieval of a proximally migrated fully covered self-expandable metal stent using biopsy forceps with a guiding sheath cannula.

Transpapillary endoscopic biliary drainage is the gold standard for resolving malignant biliary obstruction. Stent migration occasionally occurs and is troublesome to retrieve. Yamamoto and colleagues report with accompanying video on the successful retrieval of a proximally migrated stent using biopsy forceps through a guiding sheath cannula.

Objective evaluation of the resistance forces of 22-gauge EUS-FNA and fine-needle biopsy needles.

Background and Objectives: EUS-guided tissue acquisition is routinely performed for the diagnosis of gastrointestinal tract and adjacent organ lesions. Recently, various types of needles have been developed. However, how the shape of the needle tip and echoendoscope tip angle affect puncturability, has not been clarified. The aim of this experimental study was to compare the puncturability of several 22-gauge EUS-FNA and EUS-guided fine-needle biopsy (EUS-FNB) needles, and to evaluate the effects of the needle tip shape and echoendoscope tip angle on tissue puncturability. Materials and Methods: The following six major FNA and FNB needles were evaluated: SonoTip® ProControl, EZ Shot 3 Plus, Expect™ Standard Handle, SonoTip® TopGain, Acquire™, and SharkCore™. The mean maximum resistance force against needle advancement was evaluated and compared under several conditions using an echoendoscope. Results: The mean maximum resistance force of the needle alone was higher for the FNB needles than for the FNA needles. The mean maximum resistance force of the needle in the echoendoscope with free angle demonstrated that the resistance forces were between 2.10 and 2.34 Newton (N). The mean maximum resistance force increased upon increases in angle of the tip of echoendoscope, particularly in the FNA needles. Among the FNB needles, SharkCore™ had the lowest resistance force (2.23 N). The mean maximum resistance force of the needle alone, the needle in the echoendoscope with free angle, and the needle in the echoendoscope with full-up angle for SonoTip® TopGain were all similar to that of Acquire™. Conclusion: SonoTip® TopGain had similar puncturability to Acquire™ in all tested situations. Regarding the puncturability, SharkCore™ is most suitable for insertion into target lesions, when tight echoendoscope tip angle is necessary.

A fatal case of massive hemobilia caused by invasive pancreatic cancer with median arcuate ligament syndrome: A case report.

INTRODUCTION: In median arcuate ligament syndrome (MALS), the celiac artery is compressed, causing an arcade to develop in the pancreatic head, leading to ischemic symptoms and aneurysms. PATIENT CONCERNS: The patient was diagnosed with borderline resectable pancreatic cancer (PC) and MALS. Endoscopic biliary drainage with a covered metal stent (CMS) was performed for the obstructive jaundice. After the jaundice improved, a modified FOLFIRINOX regimen was initiated. Several days later, cardiopulmonary arrest occurred after hematemesis occurred. Cardiopulmonary resuscitation was performed, his blood pressure stabilized, and emergent upper endoscopy was performed. The CMS was dislodged and active bleeding was observed in the papillae. The CMS was replaced, and temporary hemostasis was achieved. Contrast-enhanced computed tomography revealed a diagnosis of extravasation from the posterior superior pancreaticoduodenal artery (PSPDA) into the biliary tract. Transcatheter arterial embolization was performed. However, the patient was subsequently diagnosed with hypoxic encephalopathy and died on day 14 of hospitalization. DIAGNOSIS: Biliary hemorrhage due to invasion of pancreatic cancer from the PSPDA associated with MALS. INTERVENTION: None. OUTCOMES: Biliary hemorrhage from the PSPDA was fatal in the patient with invasive PC with MALS. LESSONS: Since MALS associated with PC is not a rare disease, the purpose of this study was to keep in mind the possibility of fatal biliary hemorrhage.

Use of a novel self-assembling hemostatic gel as a complementary therapeutic tool for endoscopic sphincterotomy-related bleeding.

PuraStat is a novel self-assembling peptide hydrogel developed as a hemostatic agent for endoscopic and surgical procedures which can be applied to bleeding from various lesions of the gastrointestinal tract. Yamamoto and colleagues present a video showing the actual endoscopic hemostasis using PuraStat for endoscopic sphincterotomy-related bleeding.

Stent placement using the EUS-guided pancreatic duct drainage rendezvous technique for pancreatic ductal stenosis after endoscopic papillectomy.

Pancreatic ductal stenosis after endoscopic papillectomy may be particularly troublesome because of the risk of acute pancreatitis if the stenosis cannot be released. Yamamoto and colleagues report a case of successful pancreatic stent placement using the endoscopic ultrasound guided pancreatic duct drainage rendezvous technique for pancreatic ductal stenosis after endoscopic papillectomy.

Single-session endoscopic ultrasound-guided hepaticogastrostomy and pancreatic duct drainage for concomitant biliary and pancreatic duct stones in a patient with a surgically altered anatomy.

Highlight Interventional endoscopic ultrasound has become widely used although it remains challenging. Nagai and colleagues present the first case of single-session endoscopic ultrasound-guided hepaticogastrostomy and endoscopic ultrasound-guided pancreatic duct drainage, and demonstrate that it is feasible for the management of biliary and pancreatic duct stones in patients with surgically altered anatomy.