Safety of skipping the tract dilation step for EUS-guided biliary drainage in patients with unresectable malignant biliary obstruction (with video).

BACKGROUND: Thin delivery system stents can be inserted directly without the need for a tract dilation step and are expected to reduce bile leakage during endoscopic ultrasound-guided biliary drainage (EUS-BD). The present study retrospectively compared the safety and efficacy of EUS-BD using a thin metal stent (< 7.5 Fr) with those of EUS-BD using a conventional stent (≥ 7.5 Fr). METHODS: The present study enrolled 112 patients who underwent EUS-BD using metal stents for unresectable malignant biliary obstruction between April 2016 and July 2022. The primary endpoint was the rate of adverse events (AEs). The secondary endpoints were clinical success rate, procedure time, procedure success rate in the absence of the tract dilation step, recurrent biliary obstruction rate, time to biliary obstruction, and overall survival. Risk factors associated with early AEs were also evaluated. RESULTS: The rate of early AEs was significantly lower (12% vs. 35%, P = 0.013) and the procedure success without the tract dilation step was significantly higher (82% vs. 33%, P < 0.001) in the thin than in the conventional delivery system stent group. None of the other secondary endpoints differed significantly between the two groups. Multivariate analysis showed that employing the tract dilation step during EUS-BD was a significant independent risk factor for early AEs (skipping vs. employing; HR, 9.66; 95% CI, 1.13-83.0, P = 0.028). CONCLUSION: Employing the tract dilation step during EUS-BD was a significant risk factor for early AEs. Metal stents with a delivery diameter < 7.5 Fr can be inserted directly without the tract dilation step, resulting in lower early AE rates.

Impact of sarcopenia on recurrent biliary obstruction after EUS-guided biliary drainage in patients with malignant biliary obstruction.

BACKGROUND AND AIMS: Sarcopenia is an important prognostic factor for cancer patients. The aim of this study was to assess the ability of sarcopenia to predict recurrent biliary obstruction (RBO) in patients with unresectable cancer after EUS-guided biliary drainage (EUS-BD). METHODS: The study enrolled 113 patients who underwent EUS-BD using the self-expandable metal stent (SEMS) for unresectable malignant biliary obstruction (MBO) between April 2016 and December 2021 at Wakayama Medical University Hospital. The skeletal muscle index at the third lumbar spine level (L3) was calculated from computed tomography images. We analyzed the cumulative incidence of RBO at 180 days after stent insertion. Univariate and multivariate analyses were performed to identify variables significantly associated with RBO. RESULTS: Seventy-six patients were assigned to the sarcopenia group, and 37 were assigned to the non-sarcopenia group. The 180-day cumulative incidence of RBO was 11% in the non-sarcopenia group and 29% in the sarcopenia group (p = 0.034). The time to RBO was significantly shorter for the sarcopenia group (p = 0.028; Gray's test). Multivariate analyses identified sarcopenia as an independent prognostic factor for RBO (present vs absent; HR 4.61; 95% CI 1.76-12.10, p = 0.001). The rates of biliary sludge/food impaction were significantly higher in the sarcopenia group for the causes of RBO (p = 0.048). There were no significant differences between the sarcopenia and the non-sarcopenia groups with respect to related EUS-BD adverse events. CONCLUSION: Sarcopenia is an independent indicator of RBO in patients with MBO who receive EUS-BD with SEMS.

Utility of contrast-enhanced harmonic endoscopic ultrasonography for prediction of pathological response after neoadjuvant chemotherapy in patients with pancreatic cancer.

OBJECTIVES: Contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) plays an important role in the diagnosis of pancreatic lesions. The aim of this study was to evaluate whether CH-EUS is useful for predicting the treatment efficacy of neoadjuvant chemotherapy (NAC) determined by pathological response. METHODS: Patients who underwent CH-EUS before chemotherapy and surgical resection were divided into two groups according to poor (group-P) or rich tumor vascularity (group-R) determined by enhancement pattern on early- and late-phase CH-EUS. The pathological response to chemotherapy was categorized according to Evans' classification. Pathological analysis showing tumor cell destruction (>50 %) defined a good response. RESULTS: Early-phase CH-EUS classified 44 patients into group-R and 50 into group-P, whereas late-phase CH-EUS classified 10 into group-R and 84 into group-P. Early-phase CH-EUS classification resulted in significantly higher numbers of patients with a good response in the rich group (n = 19) than in the poor group (n = 4; P = 0.0015). Multivariate analysis showed that assignment to the rich group was the strongest independent factor associated with chemosensitivity (P = 0.006, hazard ratio = 5.66, 95 % confidence interval: 1.17-19.27). In resectable patients, the enhancement pattern was the only independent factor associated with chemosensitivity (group-P vs. group-R, P = 0.003; HR [95 % CI], 14.59 [1.38-154.38]). Late-phase CH-EUS did not reveal a significant difference between group-P and group-R. CONCLUSIONS: Evaluation of vascular pattern on CH-EUS could be useful for predicting the efficacy of NAC in patients with pancreatic cancer. The enhancement pattern on CH-EUS could be a one of the useful features for determining NAC indications in resectable pancreatic cancer patients.

Novel Technique of Endoscopic Ultrasonography for the Differential Diagnosis of Gallbladder Lesions and Intraductal Papillary Mucinous Neoplasms: A Single-Center Prospective Study.

Detective flow imaging endoscopic ultrasonography (DFI-EUS) is an innovative imaging modality that was developed to detect fine vessels and low-velocity blood flow without contrast agents. We evaluate its utility for the differential diagnosis of gallbladder lesions and intraductal papillary mucinous neoplasms (IPMNs). We enrolled patients who underwent DFI-EUS, e-FLOW EUS, and contrast-enhanced EUS for gallbladder lesions or IPMNs. The detection of vessels using DFI-EUS and e-FLOW EUS was compared with that via contrast-enhanced EUS and pathological findings. The vessel pattern was also categorized as regular or irregular. Of the 33 lesions included, there were final diagnoses of 13 IPMNs and 20 gallbladder lesions. DFI-EUS was significantly superior to e-FLOW EUS for discriminating between mural nodules and mucous clots and between solid gallbladder lesions and sludge using the presence or absence of vessel detection in lesions (p = 0.005). An irregular vessel pattern with DFI-EUS was a significant predictor of malignant gallbladder lesions (p = 0.002). DFI-EUS is more sensitive than e-FLOW-EUS for vessel detection and the differential diagnosis of gallbladder lesions and IPMNs. Vessel evaluation using DFI-EUS may be a useful and simple method for differentiating between mural nodules and mucous clots in IPMN, between solid gallbladder lesions and sludge, and between malignant and benign gallbladder lesions.

Shear-wave versus strain elastography in endoscopic ultrasound for the diagnosis of chronic pancreatitis.

BACKGROUND: /Objectives: Endoscopic ultrasound (EUS) elastography is a non-invasive diagnostic method for evaluating tissue elasticity. The aims of this study were to compare shear-wave elastography (SWE) and conventional strain elastography (SE) in determination of the diagnosis and degree of chronic pancreatitis (CP). METHODS: Forty-nine patients who underwent computed tomography (CT), EUS-SWE, EUS-SE, and pancreatic exocrine function testing between January 2019 and January 2022 were prospectively evaluated. CP was diagnosed according to Japan Pancreatic Society criteria (JPSC) 2019, Rosemont criteria (RC), CT findings, and pancreatic exocrine dysfunction. The cut-off values, sensitivity, and specificity for CP diagnosed according to the four criteria were calculated for EUS-SWE and EUS-SE. Relationships between values measured by either of the EUS elastography methods and the number of EUS features were also assessed. RESULTS: EUS-SWE values were positively correlated with the severity grades of RC and JPSC, but EUS-SE values were not. EUS-SWE was significantly better than EUS-SE for diagnosing CP defined according to CT findings (area under the receiver operating characteristics curve [AUROC]: 0.77 vs. 0.61, P < 0.001), RC (AUROC: 0.85 vs. 0.56, P < 0.001), JPSC 2019 (AUROC: 0.83 vs. 0.53, P < 0.001), and exocrine dysfunction (AUROC: 0.78 vs. 0.61, P < 0.001). EUS-SWE values were positively correlated with the number of EUS features, but EUS-SE values were not. CONCLUSIONS: EUS-SWE provides objective assessment for diagnosing and assessing the degree of CP defined according to the criteria of CT findings, RC, JPSC, or exocrine dysfunction, and it can be considered a non-invasive diagnostic tool for CP and exocrine dysfunction.

Contrast-Enhanced Harmonic Endoscopic Ultrasound for Diagnosis of the Aggressiveness of Pancreatic Neuroendocrine Neoplasm.

The purpose of this study is to clarify the associations between the enhancement patterns on contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) and the aggressiveness and prognosis of pancreatic neuroendocrine neoplasms (PanNENs). Patients who underwent CH-EUS and were pathologically diagnosed with PanNEN were included in this study. Patients were divided into three groups according to contrast-enhancement patterns on early-phase and late-phase imaging: "Group A", vascular rich in both phases; "Group B", vascular rich and vascular poor in early and late phases, respectively; "Group C", vascular poor in both phases. Of 39 patients, 25 were assigned to Group A, 7 to Group B, and 7 to Group C. The median overall survival was not reached in Groups A and B and was 335 days in Group C (p < 0.001). The 1-year survival rates were 100% in Group A, 60% in Group B, and 43% in Group C. Patients in Group C showed the shortest overall survival among the three groups. The vascular-poor pattern on late-phase CH-EUS had the highest sensitivity, specificity, and accuracy for aggressive PanNENs among the patterns analyzed on CH-EUS and CECT (84.6%, 91.7%, and 89.2%, respectively). CH-EUS is useful for the diagnosis of and predicting the prognosis of PanNENs.

Comparison of 22G Fork-Tip and Franseen Needles and Usefulness of Contrast-Enhanced Endoscopic Ultrasound for Diagnosis of Upper Gastrointestinal Subepithelial Lesions.

Endoscopic ultrasound (EUS)-guided tissue acquisition (EUS-TA) is less accurate in obtaining samples from gastrointestinal subepithelial lesions (SELs) ≤2 cm than from pancreatic cancers. The present study compared the usefulness of 22G Fork-tip and Franseen needles for EUS-TA and assessed the ability of contrast-enhanced harmonic EUS (CH-EUS) to diagnose SELs ≤2 cm. Fifty-seven patients who underwent EUS-TA for SELs ≤2 cm were evaluated. The primary endpoint was to compare the rate of acquisition of sufficient samples by these two needles. Secondary endpoints included technical success rate, adverse events, numbers of needle passes, and diagnostic ability of CH-EUS for SELs. Of the 57 included patients, 23 and 34 underwent EUS-TA with Fork-tip and Franseen needles, respectively. Technical success rates were 100% with both needles and adverse events occurred in zero (0%) and one (2.9%) patient with Fork-tip and Franseen needles, respectively. The rate of adequate sample acquisition was significantly higher using Fork-tip than Franseen needles (96% vs. 74%; p = 0.038). The hyper- or iso-vascular pattern on CH-EUS correlated significantly with a diagnosis of gastrointestinal stromal tumor (p < 0.001). EUS-TA with Fork-tip needles were superior to EUS-TA with Franseen needles in acquiring sufficient samples and CH-EUS was also useful for the diagnosis of SELs ≤2 cm.

Feasibility and efficacy of endoscopic reintervention after covered metal stent placement for EUS-guided hepaticogastrostomy: A multicenter experience.

Background and Objectives: Although the use of a long metal stent is favored for EUS-guided hepaticogastrostomy (EUS-HGS) for the relief of malignant biliary obstruction (MBO), endoscopic reintervention (E-RI) at the time of recurrent biliary obstruction (RBO) is challenging due to a long intragastric portion. This study evaluated the feasibility and safety of E-RI after a long partially covered metal stent (L-PCMS) placement during EUS-HGS. Materials and Methods: We performed a multicenter retrospective study between January 2015 and December 2019 examining patients with MBO who underwent E-RI for RBO through the EUS-HGS route after the L-PCMS placement. Technical and clinical success rates, details of E-RI, adverse events (AEs), stent patency, and survival time were evaluated. Results: Thirty-three patients at eight referral centers in Japan who underwent E-RI through the EUS-HGS route were enrolled. The location of MBO was distal in 54.5%. The median intragastric length of the L-PCMS was 5 cm. As the first E-RI attempt, E-RI via the distal end of the existing L-PCMS was successful in 60.6%. The overall technical and clinical success rates of E-RI were 100% and 81.8%, respectively. Liver abscess was noted in one patient. A proximal biliary stricture was associated with the clinical ineffectiveness of E-RI in multivariable analysis (odds ratio, 12.5, P = 0.04). The median survival and stent patency duration after E-RI were 140 and 394 days, respectively. Conclusions: Our study findings suggest that E-RI for RBO after EUS-HGS with a L-PCMS is technically feasible and clinically effective, without any severe AEs, especially for patients with distal MBO.

Usefulness of Contrast-Enhanced Harmonic Endoscopic Ultrasonography for Diagnosis of Malignancy in Intraductal Papillary Mucinous Neoplasm.

Intraductal papillary mucinous neoplasms (IPMNs) have a wide pathologic spectrum and it can be difficult to diagnose malignancy, including pathological grade. The aim of this study was to evaluate contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) for the diagnosis of malignant IPMN and IPMN-associated invasive carcinoma (invasive IPMC). From 5009 patients diagnosed with IPMN at Wakayama medical university between December 2009 and December 2021, 115 patients who underwent contrast-enhanced computed tomography (CE-CT), conventional EUS, CH-EUS, and surgical resection were enrolled. The detection of mural lesions was compared with pathological findings. Malignant IPMN and invasive IPMC were also assessed according to mural lesion size and vascularity on CH-EUS. CH-EUS and conventional EUS showed significantly higher accuracy than CE-CT in the detection of mural nodules (92%, 83%, and 72%, respectively) and diagnosis of malignant IPMN (75%, 73%, and 63%, respectively). An early wash-out pattern on CH-EUS was observed in significantly more patients with invasive IPMC than in those with low-, intermediate-, or high-grade dysplasia. When compared with CE-CT, CH-EUS was significantly more accurate for detecting mural nodules and more useful for diagnosing malignant IPMN. The vascular pattern on CH-EUS was also useful for diagnosing invasive IPMC.

Needle tract seeding after endoscopic ultrasound-guided tissue acquisition of pancreatic tumors: A nationwide survey in Japan.

OBJECTIVES: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) plays a crucial role in the diagnosis of pancreatic tumors. The present study aimed to investigate the current status of needle tract seeding (NTS) after EUS-TA of pancreatic tumors based on a nationwide survey in Japan. METHODS: Patients who underwent surgical resection of primary pancreatic tumors after EUS-TA performed between April 2010 and March 2018 were surveyed. The incidence rates of NTS were determined, and compared in patients with pancreatic ductal adenocarcinomas (PDACs) and other tumors, and in patients who underwent transgastric and transduodenal EUS-TA of PDACs. The detailed features and prognosis of patients with NTS were also assessed. RESULTS: A total of 12,109 patients underwent surgical resection of primary pancreatic tumors after EUS-TA. The overall incidence rate of NTS was 0.330%, and the NTS rate was significantly higher in patients with PDAC than in those with other tumors (0.409% vs. 0.071%, P=0.004). NTS was observed in 0.857% of patients who underwent transgastric EUS-TA, but in none of those who underwent transduodenal EUS-TA. Of the patients with NTS of PDACs, the median time from EUS-TA to occurrence of NTS and median patient survival were 19.3 and 44.7 months, respectively, with 97.4% of NTS located in the gastric wall and 65.8% of NTS resected. The patient survival was significantly longer in patients who underwent NTS resection than in those without NTS resection (P=0.037). CONCLUSIONS: NTS appeared only after transgastric not after transduodenal EUS-TA. Careful follow-up provides an opportunity to remove localized NTS lesions by gastrectomy.

Contrast-enhanced harmonic endoscopic ultrasonography for predicting the efficacy of first-line gemcitabine and nab-paclitaxel chemotherapy in pancreatic cancer.

BACKGROUND AND AIMS: The purpose of this study was to assess prognosis with different intratumoral vascularity on contrast-enhanced endoscopic harmonic ultrasonography (CH-EUS) in pancreatic cancer patients receiving chemotherapy. METHODS: Patients with unresectable pancreatic cancer who underwent CH-EUS before first-line gemcitabine and nab-paclitaxel (GEM and nab-PTX) therapy were classified into four groups according to vascularity on the early and late phases of contrast enhancement: "Group A″, poor on both phases; "Group B″, rich and poor on the early and late phases, respectively; "Group C″, poor and rich on the early and late phases; "Group D″, rich on both phases. Subgroups were compared in terms of progression-free survival (PFS) and overall survival (OS). We also assessed whether the results with CH-EUS correlate with those of contrast-enhanced computed tomography (CE-CT). RESULTS: On CH-EUS, 57, 64, 0, and 24 patients were classified into Groups A, B, C, and D, respectively. The median PFS of patients in groups A, B, and D was 3.9, 7.6, and 10.8 months, respectively, and the median OS were 9.5, 13.1, and 18.6 months, respectively. Both PFS and OS were longest in Group D (p < 0.001 and p < 0.001, respectively). The results of CE-CT were consistent with those of CH-EUS, and there was a correlation between CE-CT and CH-EUS. CONCLUSIONS: Evaluation of intratumoral vascularity by CH-EUS may be useful for predicting the efficacy of chemotherapy in patients with pancreatic cancer. A better response to GEM and nab-PTX can be expected in patients showing rich vascularity at both the early and late phases.

Kras Gene Analysis Using Liquid-Based Cytology Specimens Predicts Therapeutic Responses and Prognosis in Patients with Pancreatic Cancer.

BACKGROUND: Although several molecular analyses have shown that the Kras gene status is related to long-term survival of patients with pancreatic ductal adenocarcinoma (PDAC), the results remain controversial. Here, we examined the Kras gene status in a cohort of unresectable PDAC patients who underwent first-line therapy with gemcitabine and nab-paclitaxel (GA) and assessed differences in chemotherapy responses and survival. METHODS: Patients with a histological diagnosis of PDAC (based on EUS-guided fine-needle aspiration) from 2017 to 2019 were enrolled. Tumor genomic DNA was extracted from residual liquid-based cytology specimens and Kras mutations were assessed using the quenching probe method. The relationships between the Kras status and progression-free survival (PFS) and overall survival (OS) were assessed. RESULTS: Of the 110 patients analyzed, 15 had wild-type Kras. Those with the wild-type gene showed significantly longer PFS and OS than those with mutant Kras (6.9/5.3 months (p = 0.044) vs. 19.9/11.8 months (p = 0.037), respectively). Multivariate analyses identified wild-type Kras as a significant independent factor associated with longer PFS and OS (HR = 0.53 (p = 0.045) and HR = 0.35 (p = 0.007), respectively). CONCLUSIONS: The analysis of the Kras gene status could be used to predict therapeutic responses to GA and prognosis in unresectable PDAC patients.

Impact of sarcopenia on prediction of progression-free survival and overall survival of patients with pancreatic ductal adenocarcinoma receiving first-line gemcitabine and nab-paclitaxel chemotherapy.

BACKGROUND AND AIMS: Sarcopenia is an important prognostic factor for cancer patients. Here, we assessed the effects of sarcopenia on progression-free survival (PFS) and overall survival (OS) of patients with pancreatic ductal adenocarcinoma (PDAC) who underwent treatment with first-line gemcitabine and nab-paclitaxel (GEM and nab-PTX). METHODS: The study enrolled patients with unresectable PDAC who underwent chemotherapy between April 2016 and May 2020. The skeletal muscle index (SMI) at the third lumbar spine level (L3) was calculated from computed tomography (CT) images. Propensity score analysis was used to compare PFS and OS in the sarcopenia and non-sarcopenia groups. Univariate and multivariate analyses were performed to determine variables significantly associated with prognosis. RESULTS: Of the 176 patients who received first-line GEM and nab-PTX, 84 were selected and divided into two groups of 42 (the sarcopenia and the non-sarcopenia groups) by propensity score matching. The median PFS of the sarcopenia and the non-sarcopenia groups was 5.0 and 8.0 months, respectively (p = 0.004). The median OS was 10.3 and 18.1 months, respectively (p = 0.001). Multivariate analyses revealed that sarcopenia was an independent prognostic factor for PFS and OS (p = 0.004, p = 0.001, respectively). The rates of major grade 3 or 4 AEs were significantly higher in the sarcopenia group (p = 0.008). CONCLUSIONS: Sarcopenia is an independent indicator of a poor prognosis in patients with PDAC treated with first-line GEM and nab-PTX.

Clinical dilemma of endoscopic ultrasound-guided fine needle aspiration for resectable pancreatic body and tail cancer.

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a first-line procedure for definitive tissue diagnosis of pancreatic cancer because of its high accuracy and low complication rate. The overall sensitivity of EUS-FNA for the diagnosis of pancreatic cancer is approximately 90%; however, its diagnostic ability for small lesions (<10 mm) remains limited. Although EUS-FNA is a relatively safe procedure, with an overall morbidity of ≤2%, it should be noted that needle tract seeding (NTS) can occur after EUS-FNA, which may affect the patient prognosis negatively. In patients with resected pancreatic tumors, preoperative EUS-FNA is not associated with an increased risk of postoperative recurrence. However, NTS after EUS-FNA for resectable pancreatic body and tail cancer has been highlighted recently, particularly by Japanese endoscopists. Thus, the use of preoperative EUS-FNA for the diagnosis of resectable pancreatic body and tail cancer has become a clinical dilemma that challenges gastroenterologists and must be carefully considered on a case-by-case basis by weighing the benefits and risks. This review summarizes the pros and cons of performing EUS-FNA in patients with resectable pancreatic body and tail cancer and provides valuable insight for gastroenterologists treating pancreatic cancer.

A Novel Endoscopic Ultrasonography Imaging Technique for Depicting Microcirculation in Pancreatobiliary Lesions without the Need for Contrast-Enhancement: A Prospective Exploratory Study.

Detective flow imaging endoscopic ultrasonography (DFI-EUS) provides a new method to image and detect fine vessels and low-velocity blood flow without using ultrasound contrast agents. The aim of this study was to evaluate the utility of DFI-EUS for pancreatobiliary lesions and lymph nodes. Between January 2019 and January 2020, 53 patients who underwent DFI-EUS, e-FLOW EUS, and contrast-enhanced EUS were enrolled. The ability of DFI-EUS and e-FLOW EUS to detect vessels was compared with that of contrast-enhanced EUS. This article describes the DFI technique along with our first experience of its use for vascular assessment of pancreatobiliary lesions. Vessels were imaged in 34 pancreatic solid lesions, eight intraductal papillary mucinous neoplasms (IPMNs), seven gall bladder lesions, and four swollen lymph nodes. DFI-EUS (91%) was significantly superior to e-FLOW EUS (53%) with respect to detection of vessels (p < 0.001) and for discrimination of mural nodules from mucous clots in IPMN and gallbladder lesions from sludge (p = 0.046). Thus, DFI-EUS has the potential to become an essential tool for diagnosis and vascular assessment of various diseases.

Value of contrast-enhanced harmonic endoscopic ultrasound for diagnosing hepatic metastases of pancreatic cancer: A prospective study.

BACKGROUND AND AIMS: This study aimed to compare contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) with fundamental B-mode endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CE-CT) for the diagnosis of left hepatic lobe metastases of pancreatic adenocarcinoma. METHODS: In this single-center prospective study, CE-CT, EUS, and CH-EUS were performed to detect left hepatic lobe metastases in patients with pancreatic adenocarcinoma, and the detection rates were compared between EUS plus CH-EUS and the other two modalities. Subgroup comparisons of between-modality detection rate were performed in patients with only metastases of <10 mm. The number of pancreatic adenocarcinoma patients whose clinical stage and treatment strategy were changed because of EUS plus CH-EUS findings was also assessed. RESULTS: Thirty-one patients were diagnosed with left hepatic lobe metastases. For overall detection of left hepatic lobe metastases, EUS plus CH-EUS had significantly higher accuracy (94.3%) than CE-CT (86.7%) and EUS alone (87.6%) (P = 0.021 and P = 0.020, respectively). For detection of left hepatic lobe metastases < 10 mm, EUS plus CH-EUS (93.3%) was significantly superior to CE-CT (84.4%) and EUS alone (85.6%) (P = 0.021 and P = 0.020, respectively). In five of the 11 patients in whom only CH-EUS allowed detection of hepatic metastases, the stage and/or treatment strategy of the pancreatic adenocarcinoma was changed after CH-EUS. CONCLUSION: This study demonstrated that EUS plus CH-EUS has advantages over CE-CT and EUS alone with regard to the accuracy of detecting left hepatic lobe metastases, particularly small hepatic metastases and accurate staging.

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.).

Usefulness of a newly designed laser-cut metal stent with an anchoring hook and thin delivery system for EUS-guided hepaticogastrostomy in experimental settings (with video).

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HGS) is associated with high rates of adverse events. The present study evaluated the feasibility of a newly designed stent equipped with a dilatation and antimigration system for EUS-HGS in phantom and animal models. METHODS: The newly designed stent was a partially covered laser-cut stent with antimigration anchoring hooks and a thin tapered tip (7.2F). The feasibility of these stents for biliary obstruction was compared with that of conventional stents. Evaluated outcomes were resistance force to migration in phantom and ex vivo models, rates of technical success and adverse events, and histology in an in vivo model. RESULTS: The resistance forces on the distal (3.59 vs 1.73 N and 6.21 vs 1.74 N) and proximal (3.58 vs 1.5 N and 5.97 vs 1.67 N) sides in phantom and ex vivo models were significantly higher for hook stents than for conventional stents. Although EUS-HGS was successfully performed in all cases with both stents (100% [10/10] vs 100% [8/8]), the success rate of EUS-HGS without using a fistulous tract dilation device was significantly higher with hook stents (100% [10/10]) than with conventional stents (13% [1/8]). No adverse events occurred with either stent. Pathologic examination showed adhesion between the stomach and liver. CONCLUSIONS: The strong resistance to migration and the absence of the dilation step are important advantages of newly designed hook stents. These stents may therefore be feasible and safe for EUS-HGS.