Multiparametric US for Identifying Patients with High-Risk NASH: A Derivation and Validation Study.

Background Nonalcoholic fatty liver disease (NAFLD) is common in the general population but identifying patients with high-risk nonalcoholic steatohepatitis (NASH) who are candidates for pharmacologic therapy remains a challenge. Purpose To develop a score to identify patients with high-risk NASH, defined as NASH with an NAFLD activity score (NAS) of 4 or greater and clinically significant fibrosis (stage 2 [F2] or higher). Materials and Methods This was a cross-sectional secondary analysis of data prospectively collected between April 2017 and March 2019 for a group of patients with NAFLD in Japan (Japan NAFLD, the derivation data set) with contemporaneous two-dimensional shear-wave elastography and biopsy-proven NAFLD (age range, 20-89 years). Three US markers (liver stiffness [LS, measured in kilopascals], attenuation coefficient [AC, measured in decibels per centimeter per megahertz], and dispersion slope [DS, measured in meters per second per kilohertz]) were determined, together with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels and the AST-to-ALT ratio. The best-fit multivariate logistic regression model for identifying patients with high-risk NASH was determined. Diagnostic performance was assessed by using the area under the receiver operating characteristic curve (AUC). The findings were validated in an independent data set (Korea NAFLD; age range, 20-78 years). Results The Japan NAFLD data set included 111 patients (mean age, 53 years ± 18 [standard deviation]; 57 men), 84 (76%) with NASH. The Korea NAFLD data set included 102 patients (mean age, 48 years ± 18; 43 men), 55 (36%) with NASH. The most predictive model (LAD NASH score) combined LS, AC, and DS. Performance was satisfactory in both the derivation sample (AUC, 0.86; 95% CI: 0.79, 0.93) and the validation sample (AUC, 0.88; 95% CI: 0.80, 0.95). The LAD NASH score showed a positive predictive value of 86.5% and a negative predictive value of 87.5% for high-risk NASH in the derivation sample. Conclusion A score combining three US markers may be useful for noninvasive identification of patients with high-risk nonalcoholic steatohepatitis for inclusion in clinical trials and pharmacologic therapy. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Lockhart in this issue.

The Role of Multiparametric US of the Liver for the Evaluation of Nonalcoholic Steatohepatitis.

Background Nonalcoholic steatohepatitis (NASH) is diagnosed with histopathologic testing, but noninvasive surrogate markers are desirable for screening patients who are at high risk of NASH. Purpose To investigate the diagnostic performance of dispersion slope, attenuation coefficient, and shear-wave speed measurements obtained using two-dimensional (2D) shear-wave elastography (SWE) in assessing inflammation, steatosis, and fibrosis and in the noninvasive diagnosis of NASH in patients suspected of having nonalcoholic fatty liver disease (NAFLD). Materials and Methods This prospective study collected data from 120 consecutive adults who underwent liver biopsy for suspected NAFLD and were enrolled between April 2017 and March 2019. Three US parameters (dispersion slope [(m/sec)/kHz], attenuation coefficient [dB/cm/MHz], and shear-wave speed [in meters per second]) were measured using a 2D SWE system immediately before biopsy. The biopsy specimens were scored by one expert pathologist according to the Nonalcoholic Steatohepatitis Clinical Research Network criteria (119 participants underwent a histologic examination). Diagnostic performance was assessed using the area under the receiver operating characteristic curve (AUC) for the categories of inflammation, steatosis, and fibrosis. Results One hundred eleven adults (mean age, 53 years ± 18 [standard deviation]; 57 men) underwent a US examination. Dispersion slope enabled the identification of lobular inflammation, with an AUC of 0.95 (95% confidence interval [CI]: 0.91, 0.10) for an inflammation grade greater than or equal to A1 (mild), 0.81 (95% CI: 0.72, 0.89) for an inflammation grade greater than or equal to A2 (moderate), and 0.85 (95% CI: 0.74, 0.97) for an inflammation grade equal to A3 (marked). Attenuation coefficient enabled the identification of steatosis, with an AUC of 0.88 (95% CI: 0.80, 0.97) for steatosis grade greater than or equal to S1 (mild), 0.86 (95% CI: 0.79, 0.93) for steatosis grade greater than or equal to S2 (moderate), and 0.79 (95% CI: 0.68, 0.89) for steatosis grade equal to S3 (severe). Shear-wave speed enabled the identification of fibrosis, with an AUC of 0.79 (95% CI: 0.69, 0.88) for fibrosis stage greater than or equal to F1 (portal fibrosis), 0.88 (95% CI: 0.82, 0.94) for fibrosis stage greater than or equal to F2 (periportal fibrosis), 0.90 (95% CI: 0.84, 0.96) for fibrosis stage greater than or equal to F3 (septal fibrosis), and 0.95 (95% CI: 0.91, 0.99) for fibrosis stage equal to F4 (cirrhosis). The combination of dispersion slope, attenuation coefficient, and shear-wave speed showed an AUC of 0.81 (95% CI: 0.71, 0.91) for the diagnosis of NASH. Conclusion Dispersion slope, attenuation coefficient, and shear-wave speed were found to be useful for assessing lobular inflammation, steatosis, and fibrosis, respectively, in participants with biopsy-proven nonalcoholic fatty liver disease. © RSNA, 2020 Online supplemental material is available for this article.

Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver - Update 2020 - WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS.

The present, updated document describes the fourth iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS), first initiated in 2004 by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). The previous updated editions of the guidelines reflected changes in the available contrast agents and updated the guidelines not only for hepatic but also for non-hepatic applications.The 2012 guideline requires updating as previously the differences of the contrast agents were not precisely described and the differences in contrast phases as well as handling were not clearly indicated. In addition, more evidence has been published for all contrast agents. The update also reflects the most recent developments in contrast agents, including the United States Food and Drug Administration (FDA) approval as well as the extensive Asian experience, to produce a truly international perspective.These guidelines and recommendations provide general advice on the use of ultrasound contrast agents (UCA) and are intended to create standard protocols for the use and administration of UCA in liver applications on an international basis to improve the management of patients.

Irreversible Electroporation versus Radiofrequency Ablation: Comparison of Systemic Immune Responses in Patients with Hepatocellular Carcinoma.

PURPOSE: Irreversible electroporation (IRE) differs from thermal radiofrequency (RF) ablation, especially in terms of the reparative process in the ablation zone induced. To elucidate this, the systemic immune responses after 2 mechanistically different types of ablation (IRE and RF ablation) were evaluated in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Twenty-one patients with HCC who underwent either RF ablation (n = 11) or IRE (n = 10) were studied. Peripheral blood samples were collected from all patients at 4 timepoints: before ablation, within 1 hour after ablation, 1 day after ablation, and 4 days after ablation. The phenotypes and functions of immune cells in peripheral blood and serum levels of cytokines and chemokines were monitored and analyzed using the mixed-effects model. Follow-up radiological images were also obtained to assess temporal changes in the ablation zone. RESULTS: The most significant difference was seen in the levels of macrophage migration inhibitory factor (MIF) in the IRE group compared to the RF ablation group (P = .0011): the serum levels of MIF in the IRE group significantly increased immediately after IRE and then rapidly decreased to the pre-ablation range 1 day after IRE, but, in contrast, no consistent trend was observed in the RF ablation group. The axial diameter (P = .0009) and area (P = .0192) of the ablation zone of IRE were significantly smaller than those of RF ablation 1 year after ablation. CONCLUSIONS: IRE was found to be associated with a significant early increase in MIF levels, which may facilitate the early reparative process and result in significant shrinkage of the ablation zone.

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

AIM: The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. METHODS: Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. RESULTS: In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. CONCLUSION: The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia.

Serum Metabolomic Profiles for Human Pancreatic Cancer Discrimination.

This study evaluated the clinical use of serum metabolomics to discriminate malignant cancers including pancreatic cancer (PC) from malignant diseases, such as biliary tract cancer (BTC), intraductal papillary mucinous carcinoma (IPMC), and various benign pancreaticobiliary diseases. Capillary electrophoresismass spectrometry was used to analyze charged metabolites. We repeatedly analyzed serum samples (n = 41) of different storage durations to identify metabolites showing high quantitative reproducibility, and subsequently analyzed all samples (n = 140). Overall, 189 metabolites were quantified and 66 metabolites had a 20% coefficient of variation and, of these, 24 metabolites showed significant differences among control, benign, and malignant groups (p < 0.05; Steel-Dwass test). Four multiple logistic regression models (MLR) were developed and one MLR model clearly discriminated all disease patients from healthy controls with an area under receiver operating characteristic curve (AUC) of 0.970 (95% confidential interval (CI), 0.946-0.994, p < 0.0001). Another model to discriminate PC from BTC and IPMC yielded AUC = 0.831 (95% CI, 0.650-1.01, p = 0.0020) with higher accuracy compared with tumor markers including carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), pancreatic cancer-associated antigen (DUPAN2) and s-pancreas-1 antigen (SPAN1). Changes in metabolomic profiles might be used to screen for malignant cancers as well as to differentiate between PC and other malignant diseases.

Usefulness of a traction method using dental floss and a hemoclip for gastric endoscopic submucosal dissection: a propensity score matching analysis (with videos).

BACKGROUND AND AIMS: Although endoscopic submucosal dissection (ESD) is a significant advancement in therapeutic endoscopy, it is a complicated technique and requires considerable expertise. In this exploratory study, we evaluated the efficacy of a simple traction method that uses dental floss and a hemoclip (DFC) and was developed to overcome the technical difficulties of ESD. METHODS: In total, 238 early gastric cancers treated by ESD between May 2012 and December 2014 at Tokyo Medical University were retrospectively reviewed. Lesions treated by conventional ESD (n = 185) and by ESD with DFC (ESD-DFC) (n = 53) were compared. Multivariable analyses and propensity score matching were used to compensate for the differences in age, sex, resected specimen size, lesion location, lesion position, presence of ulceration, and operator level. The procedure time, rate of en bloc and complete resection, and rates of adverse events were evaluated between the 2 groups. RESULTS: Propensity score matching analysis created 43 matched pairs. Adjusted comparisons between ESD-DFC and conventional ESD showed similar treatment outcomes (en bloc resection rate: 97.7% vs 100%, P = .315; complete resection rate: 90.7% vs 95.3%, P = .397; perforation during ESD rate: 2.3% vs 2.3%, P = 1.000; post-ESD bleeding rate: 4.7% vs 4.7%, P = 1.000) but a significantly shorter procedure time for ESD-DFC (82.2 ± 79.5 minutes vs 118.2 ± 71.6 minutes, P = .002). CONCLUSION: ESD-DFC facilitated rapid ESD with good visualization and traction while ensuring high curability and safety.

Multicenter, prospective, crossover trial comparing the door-knocking method with the conventional method for EUS-FNA of solid pancreatic masses (with videos).

BACKGROUND AND AIMS: There are currently no prospective, controlled trials of needle puncture speed in EUS-guided FNA (EUS-FNA). In this study, we prospectively evaluated the accuracy of histological diagnosis and the tissue acquisition rate of EUS-FNA by using the door-knocking method (DKM) with a standard 22-gauge needle. METHODS: From November 2013 to August 2014, 82 patients who had solid pancreatic masses underwent EUS-FNA in which the conventional method (CM) and DKM with 2 respective passes in turn were used. The primary outcomes of this study were the accuracy of histological diagnosis and the rates of tissue acquisition in 2 FNA procedures by using these 2 methods. RESULTS: Although the successful tissue acquisition rate for histology was not significantly different with the DKM and CM (91.5% vs 89.0%, P = .37), the high cellularity tissue acquisition rate for histology with the DKM was significantly superior to that with the CM (54.9% vs 41.5%, P = .03). However, adequate quality rate and accuracy were not different in the DKM and CM (78.0% vs 80.5%, P = .42 and 76.8% vs 78.0%, P = .50, respectively). In the transgastric puncture group, although the adequate quality rate and accuracy were similar in the DKM and CM (84.1% vs 79.4%, P = .30 and 84.1% vs 76.2%, P = .11, respectively), the tissue acquisition rate tended to be higher with the DKM than the CM (93.7% vs 85.7%, P = .06). Moreover, the high cellularity tissue acquisition rate was significantly better with the DKM than the CM (63.5% vs 39.7%, P = .002). On the other hand, in the transduodenal puncture group, although the tissue acquisition rate was similar with the DKM and CM (84.2% vs 100%, P = .13), the adequate quality rate and accuracy were significantly lower with the DKM than with the CM (57.9% vs 84.2%, P = .03 and 52.6% vs 84.2%, P = .02, respectively). CONCLUSION: EUS-FNA by using a 22-gauge needle with the DKM did not improve the accuracy of histological diagnosis, but enabled acquisition of a larger amount of tissue specimen by using transgastric puncture. ( TRIAL REGISTRATION: http://www.umin.ac.jp/english/: UMIN000012127.).

Balloon enteroscopy-assisted ERCP in patients with Roux-en-Y gastrectomy and intact papillae (with videos).

BACKGROUND AND AIMS: Balloon enteroscopy-assisted ERCP has provided a marked improvement in the success rate of reaching the papilla and consecutive ERCP procedures in patients with surgically altered anatomy in the Roux-en-Y reconstruction setting. However, limited data are available on the outcome of balloon enteroscopy-assisted ERCP in patients with Roux-en-Y anatomy who have naïve papillae. We retrospectively evaluated the feasibility of balloon enteroscopy-assisted ERCP in Roux-en-Y reconstruction after total or subtotal gastrectomy (RYG) with native papillae. METHODS: We performed 123 ERCP procedures in 109 patients with RYG. Among these patients, 90 consecutive ERCPs in 90 patients with native papillae were included. When selective biliary cannulation failed, the double-guidewire technique, the precut technique, or the rendezvous technique were performed as advanced cannulation methods. RESULTS: The overall success rate of reaching the papilla was 93.5% (115/123). The total procedure success rate was 88.1% (96/109). The adverse event rate was 7.3% (8/109). The success rate of the standard cannulation of the intact papilla was 67.8% (61/90). The final cannulation success rate was 95.6% (86/90) by using advanced cannulation methods. CONCLUSIONS: Standard cannulation of the intact papilla in RYG cases remains challenging and uncertain. The use of various advanced cannulation methods improves the deep cannulation rate. Once selective cannulation succeeds, the treatment success rate is very high.

Computer-aided diagnosis for estimating the malignancy grade of hepatocellular carcinoma using contrast-enhanced ultrasound: an ROC observer study.

BACKGROUND & AIMS: We are developing a computer-aided diagnosis (CAD) system for estimating the malignancy grade of hepatocellular carcinoma (HCC) using contrast-enhanced ultrasound (CEUS). In this study, observers estimated the malignancy grade of HCC with and without the cues provided by CAD. MATERIALS AND METHODS: Institutional review board approval was obtained and informed consent was waived. A total of 232 histologically confirmed HCCs were studied: 76 well-differentiated HCC (w-HCC), 133 moderately differentiated HCC (m-HCC), and 23 poorly differentiated HCC (p-HCC). In this observer study, CEUS vascular images acquired using the maximum intensity projection technique were displayed together with static B-mode and Kupffer-phase (defined as 10 min after injection) images. Five hepatologists independently assigned confidence ratings for the malignancy grade of each HCC. Each hepatologist first read each case without CAD and then immediately afterwards with CAD. The observers' rating data were evaluated by multireader multicase receiver operating characteristic (ROC) analysis. RESULTS: The overall sensitivity of our CAD system for discrimination between three histological differentiation grades of HCC was 87.5% (203/232). For discrimination between w-HCC and m/p-HCC, the mean area under the ROC curve (AUC) for the five observers was significantly improved from 0.779 ± 0.074 to 0.872 ± 0.090 with CAD (P = 0.0069). For discrimination between m-HCC and p-HCC, the mean AUC was also significantly improved from 0.713 ± 0.107 to 0.863 ± 0.101 with CAD (P = 0.0321). CONCLUSION: The use of our CAD system can significantly improve the diagnostic performance of hepatologists in discriminating between three histological differentiation grades of HCC using CEUS.

Five biopsy specimens from the proximal part of the tumor reliably determine HER2 protein expression status in gastric cancer.

BACKGROUND: National guidelines recommend trastuzumab for treatment of patients with metastatic HER2-positive gastric cancer (GC). There is currently no guideline indicating the number of biopsy specimens and the location from which they should be obtained to reliably determine the human epidermal growth factor receptor 2 (HER2) status in GC. The aim of this pilot study was (a) to quantify HER2-positive tumor cells in different tumor regions to assess the spatial heterogeneity of HER2 expression and (b) to establish the required number of biopsy specimens and the location from which they should be obtained within the tumor to achieve concordance between HER2 expression status in the biopsy specimens and the resection specimen. METHODS: HER2 expression was quantified in six different regions of 24 HER2-positive GC and in six virtual biopsy specimens from different luminal regions. Intratumoral regional heterogeneity and concordance between HER2 status in the biopsy specimens and the resection specimen were analyzed. RESULTS: HER2-positive cells were more frequent in the luminal tumor surface compared with deeper layers (p < 0.001). GCs with differentiated histological features were more commonly HER2 positive (p < 0.001). Assessment of HER2 expression status in five biopsy specimens was sufficient to achieve 100 % concordance between the biopsy specimens and the resection specimen. CONCLUSIONS: This is the first study to suggest preferential HER2 positivity at the luminal surface in GC and to establish a minimum number of biopsy specimens needed to obtain a biopsy HER2 result which is identical to that from the whole tumor. Our study suggests that HER2 testing in five tumor-containing endoscopic biopsy specimens from the proximal (oral) part of the tumor is advisable. The results from this pilot study require validation in a prospective study.

Branched-chain amino acid-enriched nutrient increases blood platelet count in patients after endoscopic injection sclerotherapy.

AIM: Protein and energy malnutrition is a severe problem for patients with liver cirrhosis (LC) and fasting often induces starvation which is a vitally important outcome. Dietary restriction is essential for endoscopic injection sclerotherapy (EIS) in patients with risky esophageal varices, thereby creating the possible exacerbation of nutritional state and inducing liver dysfunction. Whether EIS induces nutritional deficiency in LC patients and the effects of branched-chain amino acid (BCAA)-enriched nutrient are prospectively investigated. METHODS: A total of 61 LC patients were randomly divided into an EIS monotherapy group (non-BCAA group, n = 31) and an EIS combined with BCAA therapy group (n = 30). Platelet count, blood chemistry and somatometry values were prospectively measured at five time points. RESULTS: The platelet counts before treatment were at the same level in both groups (P = 0.72). Three months after treatment, the counts decreased in the non-BCAA group; however, they increased in the BCAA group (P = 0.019). Body mass index, triceps skin fold thickness and arm muscle circumference significantly decreased in both groups. The BCAA and tyrosine ratio value increased only in the BCAA group (P < 0.01). The skeletal muscle volume measured by InBody720 significantly decreased in the non-BCAA group (P < 0.001). CONCLUSION: EIS induced protein-energy malnutrition, however, skeletal muscle volume was maintained by taking BCAA. Administration of BCAA had some effect in maintaining the nutritional state, and may improve the platelet count. Taking a greater amount of nutrients and shorter dietary restriction period or hospitalization was desirable.

Key Issues Associated with Helicobacter pylori Eradication.

Eradication of Helicobacter pylori causes improvement of gastric atrophy and intestinal metaplasia. Gastric acid secretion levels in corpus predominant gastritis increase after eradication. These changes can increase the risk of reflux esophagitis and low-dosage aspirin ulcers. Although eradication may reduce the overall risk of gastric cancer, a certain degree of risk remains, related to the extent of atrophy and intestinal metaplasia. Many post-eradication gastric cancers are the early depressed type, with low levels of epithelial atypia, and therefore can be difficult to distinguish endoscopically from benign erosion. Further research is required in this area.

Diagnostic potential of endoscopic ultrasonography-elastography for gastric submucosal tumors: A pilot study.

BACKGROUND AND AIM: Qualitative diagnosis for gastric submucosal tumors (SMT) is not easy. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in combination with EUS-elastography (EUS-EG) is reported useful for qualitatively diagnosing pancreatic tissues. We prospectively studied whether EUS-EG could be useful in qualitative diagnosis of gastric SMT. METHODS: We prospectively registered 25 consecutive patients with gastric SMT diagnosed by esophagogastroduodenoscopy and carried out qualitative evaluations using EUS-EG (May 2013 to March 2015) followed by histopathological diagnosis using EUS-FNA or endoscopic mucosal cutting biopsy. Elastic scores of gastric SMT were compared to the cytological diagnosis. RESULTS: Of 25 patients, 22 had a confirmed cytological diagnosis. Regarding the Giovannini elastic score, of three patients with aberrant pancreas, one was score 1 and two were score 2; of eight patients with leiomyoma, seven were score 2 and one was score 3. Both of two patients with schwannoma were score 4. Of nine patients with gastrointestinal stromal tumor, six were score 4 and three were score 5. Gastrointestinal stromal tumor (GIST) is harder than other types of gastric SMT, and our study's findings suggested the usefulness of EUS-EG, which can also assess tumor hardness of gastric SMT. CONCLUSION: EUS-EG might be helpful for the differential diagnosis of gastric SMT, especially to differentiate GIST from other SMT.

Investigation modalities for evaluation of esophageal clearance function.

The clearance of the esophagus is to transport food boluses from the pharynx to the stom- ach through peristaltic motion. This occurs through the primary peristaltic wave, triggered by swallowing, passing from the upper to lower esophagus in a sequence of contractions and relaxations. Investigation modalities for evaluation of esophageal clearance function include esophageal manometry (included high resolution manometry), esophageal radiography (barium swallow), esophageal scintigraphy, ultrasonography, impedance methods and com- bination with transnasal endoscopy and manometry. Of these, evaluation of esophageal clear- ance is conducted quantitative assessment of esophageal motility as well as transient lower esophageal sphincter relaxation(TLESR) in reflux esophagitis.

EUS-guided drainage of hepatic abscess and infected biloma using short and long metal stents (with videos).

BACKGROUND: Currently, few reports exist on EUS-guided hepatic abscess drainage (EUS-HAD) and EUS-guided biloma drainage (EUS-BLD) using a metal stent. OBJECTIVE: We evaluated the technical success rate and efficacy of EUS-HAD and EUS-BLD for patients with hepatic abscess (HA) and infected biloma. DESIGN: Retrospective case series. SETTING: Single tertiary referral medical center. PATIENTS: We evaluated 7 HA and 6 infected biloma patients who were treated between August 2013 and August 2014 at Tokyo Medical University Hospital. INTERVENTIONS: EUS-HAD or EUS-BLD using a short (length, 2 or 3 cm) or long (length, 6 or 8 cm) self-expandable fully covered metal stent. MAIN OUTCOME MEASUREMENTS: Technical success, clinical success, and adverse event. RESULTS: The overall technical success rate was 100% in both EUS-HAD and EUS-BLD. The clinical success rates of EUS-HAD and EUS-BLD at the first session were 71.4% and 83.3%, respectively. Direct endoscopic necrosectomy was required in 1 case each of HA and infected biloma. The final clinical success rate was 100%. There were no procedure-related adverse events or cases of recurrence during the follow-up period (median, 83.5 days; range, 24-396 days). LIMITATIONS: Small sample size and no control group. CONCLUSIONS: EUS-HAD and EUS-BLD using a metal stent can be performed safely and effectively for HA and infected biloma.

A newly designed plastic stent for EUS-guided hepaticogastrostomy: a prospective preliminary feasibility study (with videos).

BACKGROUND: There are currently no dedicated plastic stents for EUS-guided hepaticogastrostomy (EUS-HGS). OBJECTIVE: We prospectively evaluated the feasibility and the technical and functional success rates of our newly designed plastic stent for EUS-HGS. DESIGN: Prospective preliminary feasibility study. SETTING: A tertiary-care referral center. PATIENTS: Twenty-three consecutive patients were treated. The reasons for requiring EUS-HGS were periampullary tumor invasion (n=9), altered anatomy (n=7), failed duodenal intubation (n=3), and previous ERCP failure (n=4). INTERVENTIONS: An 8F single-pigtail plastic stent with 4 flanges was placed for EUS-HGS. MAIN OUTCOME MEASUREMENTS: Technical success, clinical success, and adverse events according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: All stents were successfully deployed without procedural adverse events (100% technical success rate). Bleeding from the punctured gastric wall occurred in 1 patient 3 days postoperatively. We exchanged the plastic stent for a fully covered self-expandable metal stent. A mild adverse event of self-limited abdominal pain occurred in 3 patients. Treatment success was achieved in all patients. The occlusion rate was 13.7% (3/22) during the median follow-up period (5.0 months, range 0.5-12.5 months). The median duration of stent patency was 4.0 months (range 0.5-9.0 months). There was no stent migration or dislocation during the follow-up period. LIMITATIONS: Small number of patients and lack of a control group. CONCLUSIONS: This newly designed single-pigtail plastic stent dedicated for EUS-HGS was technically feasible and can possibly be used for highly selected patients with advanced malignancy or benign stricture. ( TRIAL REGISTRATION: http://www.umin.ac.jp/english/: UMIN000012993.).

Initial evaluation of a new plastic pancreatic duct stent for endoscopic ultrasonography-guided placement.

There are currently no plastic pancreatic duct stents that have been designed for endoscopic ultrasonography (EUS)-guided placement. This study prospectively evaluated the feasibility and efficacy of a new, single-pigtail, plastic stent. Eight patients with main pancreatic duct stricture or stenotic pancreatojejunostomy underwent EUS-guided placement of the pancreatic duct stent. The stent was placed successfully in all cases (8/8). Treatment success was achieved in all cases (8/8). A mild adverse event associated with the procedure was observed in one patient but there were no other adverse events during a mean follow-up of 7.4 months. This new pancreatic duct stent appears to be feasible and effective for EUS-guided stenting.

Endoscopic ultrasound-guided placement of plastic vs. biflanged metal stents for therapy of walled-off necrosis: a retrospective single-center series.

BACKGROUND AND STUDY AIMS: Recently, a novel fully covered and biflanged metal stent (BFMS)dedicated to the drainage of walled-off necrosis(WON) was developed. The aim of this study was to retrospectively evaluate the safety, efficacy, and cost performance of drainage of WON using the novel BFMS compared with a traditional plastic stent. PATIENTS AND METHODS: A total of 70 patients with symptomatic WON were treated under endoscopic ultrasound (EUS) guidance. Initial drainage was conducted using the single gateway technique with placement of one or more plastic stents or a single BFMS.If drainage was unsuccessful,direct endoscopic necrosectomy (DEN)was performed. RESULTS: There were no statistically significant differences in rates of technical success, clinical success,and adverse events between plastics stents and BFMS, despite the size of WON in the BFMS group being significantly larger than that in the plastic stent group (105.6 vs. 77.1 mm; P=0.003).The mean procedure times for the first EUS-guided drainage and for re-intervention were significantly shorter in the BFMS group than in the plastic stent group (28.8±7.1 vs. 42.6±14.2, respectively,for drainage, P<0.001; and 34.9±8.5 vs.41.8±7.6, respectively, for re-intervention, P<0.001). There was no statistically significant difference in the total cost between plastic stent and BFMS use in the treatment of WON ($5352vs. $6274; P=0.25). CONCLUSIONS: Plastic stents and BFMS were safe and effective for the treatment of WON. In particular,BFMS placement appeared to be preferable for initial EUS-guided drainage and additional reintervention(e.g. DEN) as it reduced the procedure time. Prospective randomized controlled trials are warranted.

Morphologic and Histologic Changes in Gastric Adenomas After Helicobacter pylori Eradication: A Long-Term Prospective Analysis.

BACKGROUND: Helicobacter pylori infection causes gastric neoplasia via development of chronic atrophic gastritis and intestinal metaplasia. The effect of H. pylori eradication on pre-existing gastric neoplasias is still controversial. The aim of this study was to use long-term observation to clarify morphologic and histologic changes in gastric adenomas following H. pylori eradication. MATERIALS AND METHODS: Twenty-seven patients with gastric adenomas (revised Vienna classification category 3 or 4.1) who underwent successful H. pylori eradication between April 1996 and December 1997 were followed up at regular intervals with endoscopic and histologic examination. The association between macroscopic and histologic regressions of the lesions and the following patient and lesion characteristics was assessed with univariate analysis: follow-up period, age, sex, serum pepsinogen level, lesion size, lesion location, and histologic gastritis. RESULTS: The mean follow-up period was 91.9 months (range 44-181 months). Twelve lesions (44.4%) showed macroscopic regression, of which 7 (25.9% of the total) also showed histologic regression, with the mean duration from H. pylori eradication to complete macroscopic and histologic regression being 19.9 months. The other 15 lesions (55.6%) remained stable macroscopically and histologically, of which 6 (22.2% of the total) progressed to malignancy during the follow-up period. Univariate analysis revealed that female sex (p = .005), smaller lesion size (p = .025), higher baseline serum pepsinogen II level (p = .041), and absence of intestinal metaplasia in the greater curvature of the corpus (p = .026) were significantly associated with complete regression. CONCLUSIONS: Helicobacter pylori eradication may induce regression in some gastric adenomas.