Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial.

BACKGROUND: The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC. METHODS: Patients recruited from 16 hospitals received gemcitabine (1000 mg/m2, D 1, 8, and 15)/capecitabine (830 mg/m2 BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety. RESULTS: Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively. CONCLUSIONS: GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC. CLINICAL TRIAL REGISTRATION: NCT02854072.

EUS-guided FNA and biopsy for cytohistologic diagnosis of gallbladder cancer: a multicenter retrospective study.

BACKGROUND AND AIMS: EUS-guided FNA and biopsy (EUS-FNAB) is a standard diagnostic procedure for pancreatic masses but not gallbladder (GB) cancer (GBC). The aim of this study was to investigate the efficacy and safety of EUS-FNAB for patients with suspected GBC. METHODS: Data were analyzed from patients who underwent EUS-FNAB for suspected GBC in 3 hospitals between 2010 and 2023. The diagnostic performance and safety of EUS-FNAB according to characteristic factors were calculated and compared. RESULTS: Of 170 patients, 163 had GBC. EUS-FNAB samples were obtained from the GB in 125 patients and sites other than the GB in 45 patients. The overall sensitivity, specificity, and accuracy were 83.4%, 100%, and 84.1%, respectively. The sensitivity and accuracy for patients with GB samples were 80.8% and 81.6%; for patients without GB samples, these values were 90.7% and 91.1%. The sensitivity and accuracy were higher with fine-needle biopsy needles than with FNA needles and with ≤22-gauge needles than with 25-gauge needles. However, no significant differences were observed between the GB and lymph node samples. GB lesions <40 mm in size, wall-thickening type, fundal location, absence of extensive liver invasion, and distant metastasis were more frequent in patients without GB samples than in patients with GB samples. Four mild bleeding events were the only reported adverse events. CONCLUSIONS: EUS-FNAB was safe and showed high diagnostic performance for patients with suspected GBC, regardless of the target site. When appropriate GB targeting is difficult, targeting the lymph nodes would be a good strategy with comparable outcomes.

Safety and efficacy of remimazolam versus propofol during endoscopic ultrasound: A multicenter randomized controlled study.

BACKGROUND AND AIMS: Propofol, a widely used sedative in gastrointestinal endoscopic procedures, is associated with cardiorespiratory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine sedative with rapid onset and minimal cardiorespiratory depression. This study aimed to compare the safety and efficacy of remimazolam and propofol during endoscopic ultrasound (EUS) procedures. METHODS: A multicenter randomized controlled study was conducted between October 2022 and March 2023 in patients who underwent EUS procedures. Patients were randomly assigned to receive either remimazolam or propofol as a sedative agent. The primary endpoint was cardiorespiratory adverse events during the procedure, including desaturation, respiratory depression, hypotension, and tachycardia. Secondary endpoints included the time to achieve sedation, recovery time, quality of sedation, pain at the injection site, and satisfaction of both the endoscopists and patients. RESULTS: Four hundred patients enrolled in the study: 200 received remimazolam (10.8±7.7 mg) and 200 received propofol (88.0±49.1 mg). For cardiorespiratory adverse events, the remimazolam group experienced fewer occurrences than the propofol group (8.5% vs. 16%, p=0.022). There was a non-significant trend toward less oxygen desaturation (1.0% vs 3.5%, p= 0.09), respiratory depression (0.5% vs 1.5%, p= 0.62), hypotension (2.5% vs 5.5%, p=0.12) and tachycardia (4.5% vs 5.5%, p=0.68) with remimazolam than with propofol. Remimazolam showed a shorter induction time than propofol, while maintaining comparable awakening and recovery times. Injection site pain was significantly lower in the remimazolam group than in the propofol group. The remimazolam group demonstrated a significantly higher quality of sedation and satisfaction scores than the propofol group, as evaluated by both endoscopists and patients. CONCLUSION: Remimazolam was superior to propofol in terms of safety and efficacy during EUS examinations.

Diagnostic performance of endoscopic ultrasound elastography for differential diagnosis of solid pancreatic lesions: A propensity score-matched analysis.

BACKGROUND: Endoscopic ultrasound-elastography (EUS-EG) is a non-invasive complementary diagnostic method for differential diagnosis of solid pancreatic lesions (SPL). However, the optimal strain ratio (SR) value and diagnostic performance of EUS-EG have not yet been determined in pancreatic neuroendocrine neoplasm (PNEN), mass-forming pancreatitis (MFP), and pancreatic ductal adenocarcinoma (PDAC). We aimed to determine the optimal SR value in EUS-EG for differential diagnosis of SPLs. METHODS: Patients who underwent EUS-EG for SPL evaluation between July 2016 and June 2019 were retrospectively investigated. Patients were divided into three groups based on the final diagnosis (PNEN, MFP, or PDAC). Patient demographics, characteristics of SPL, and EUS-EG were compared. RESULTS: The mean (± standard deviation) SR value for each group were 11.85 ± 7.56 (PNEN, n = 10), 11.45 ± 5.97 (MFP, n = 37), and 22.50 ± 13.19 (PDAC, n = 87). Multinomial logistic regression analysis revealed that an increase of SR value was significantly associated with PDAC (PNEN versus PDAC, p = 0.0216; MFP versus PDAC, p = 0.0006). The optimal cut-off value for differential diagnosis was confirmed as 17.14 after propensity score matching. CONCLUSIONS: We provided the optimal cut-off SR values for differential diagnosis between MFP and PDAC. EUS-EG can be used as a supplementary diagnostic method in the diagnosis of SPLs. (Clinical trial registration number: https://cris.nih.go.kr/cris: KCT0002082).

In-stent radiofrequency ablation with uncovered metal stent placement for tumor ingrowth/overgrowth causing self-expandable metal stent occlusion in distal malignant biliary obstruction: multicenter propensity score-matched study.

BACKGROUND AND AIMS: In patients with unresectable malignant biliary obstruction (MBO), endoscopic drainage with a self-expandable metal stent (SEMS) is a well-established treatment, but stent patency is limited. This study aimed to evaluate the efficacy of in-stent radiofrequency ablation (IS-RFA) followed by uncovered SEMS placement for the management of occluded SEMSs. METHODS: From 2016 to 2020, 48 patients with recurrent biliary obstruction due to tumor ingrowth or overgrowth after SEMS placement for pancreatobiliary cancer in 3 tertiary hospitals were analyzed. For distal MBO, patients in the RFA group were treated with IS-RFA and uncovered SEMS placement, and those in the control group were treated with uncovered SEMS placement alone. Patients in both groups were matched on the basis of propensity scores in a 1:1 ratio. RESULTS: The median time to recurrent biliary obstruction (TRBO) was 117 days in the RFA group and 82.5 days in the control group (P = .029). No significant differences in median overall survival were detected between the 2 groups (170 days vs 72 days; P = .902). No significant adverse events were reported after the second SEMS placement in either group, but 2 cases of mild cholangitis were reported in the control group. Ablation was interrupted in 5 patients (35.7%) of the RFA group owing to in-stent contact, but sufficient ablative energy was delivered in the majority of the patients (92.9%) after IS-RFA was repeated in the same session. CONCLUSIONS: IS-RFA followed by an uncovered SEMS is safe and feasible and may improve TRBO as a stent revision for occluded SEMSs in pancreatobiliary cancer.

Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial.

BACKGROUND AND AIMS: In a recent randomized controlled trial, a double bare metal stent (DBS) showed better stent patency than single-layer metal stents. However, clear evidence comparing the efficacy of uncovered (UCDBS) and partially covered (PCDBS) DBSs for distal malignant biliary obstruction (MBO) is lacking. Therefore, we compared the clinical outcomes including stent patency of UCDBSs versus PCDBSs. METHODS: A multicenter, randomized study was performed in patients with distal MBO. The primary endpoint was stent patency. Secondary endpoints were the proportion of patients with patent stents at 6 months, risk factors for stent dysfunction, overall survival, technical and clinical success rates of stent placement, and other adverse events (AEs). RESULTS: Among 258 included patients, 130 were randomly assigned to the PCDBS group and 128 to the UCDBS group. The mean duration of stent patency of the PCDBS (421.2 days; 95% confidence interval [CI], 346.7-495.7) was longer than that of the UCDBS (377.4 days; 95% CI, 299.7-455.0), although total stent dysfunction and stent dysfunction within 6 months were not different between groups. Multivariate analysis indicated that chemotherapy after stent placement was a significant factor for overall survival (hazard ratio, .570; 95% CI, .408-.796) and had a marginal impact on stent patency (hazard ratio, 1.569; 95% CI, .923-2.667). There were no remarkable differences in AEs, including pancreatitis, cholecystitis, and stent migration, between the 2 groups. CONCLUSIONS: The use of PCDBSs compared with UCDBSs in patients with distal MBO has unclear benefits regarding stent patency and overall survival, although PCDBSs have a lower rate of tumor ingrowth. (Clinical trial registration number: NCT02937246.).

Long-term outcomes and predictors of adverse events of EUS-guided hepatico-gastrostomy for malignant biliary obstruction: Multicenter, retrospective study.

BACKGROUND AND AIMS: Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) may be a feasible and useful alternative in patients with malignant biliary obstruction (MBO) after failed endoscopic retrograde cholangiopancreatography (ERCP). To date, the risk factors for adverse events (AEs) and long-term outcomes of EUS-HGS have not been fully explored according to stent type. Therefore, we evaluated potential risk factors for AEs and long-term outcomes of EUS-HGS. METHODS: In total, 120 patients who underwent EUS-HGS were retrospectively reviewed. A multivariate analysis through Cox proportional hazard and logistic regression model was used to identify the risk factors for stent dysfunction and AEs, respectively. Stent patency and patient survival were evaluated using Kaplan-Meier plots with a log-rank test for each stent. RESULTS: The technical and clinical success rates were 96.2% (102/106) and 83.0% (88/106). The median duration of stent patency was longer in self-expandable metal stents (SEMS) compared to plastic stents (PS) (158 vs. 108 days). Kaplan-Meier analysis indicated that the type of stent was not associated with stent patency (Hazard ratios [HR] 0.997, 95% confidence interval [CI] [0.525-1.896]) or overall survival. In addition, multivariate analysis indicated that hilar MBO significantly associated with stent dysfunction (HR, 2.340; 95% CI, 1.028-5.326, p = 0.043) and late AEs. CONCLUSIONS: Given the lower incidence of AEs and better long-term outcomes of EUS-HGS, it can be considered a safe alternative to ERCP or percutaneous approaches regardless of which stent is used. Furthermore, hilar MBO was established as a potential risk factor for stent dysfunction and late AEs.

Comparison of contrast-enhanced versus conventional EUS-guided FNA/fine-needle biopsy in diagnosis of solid pancreatic lesions: a randomized controlled trial.

BACKGROUND AND AIMS: Contrast-enhanced harmonic EUS (CEH-EUS) is useful in the differential diagnosis of solid pancreatic lesions (SPLs). However, there is lack of verification about the usefulness of CEH-EUS-guided FNA/fine-needle biopsy (FNB) sampling. This study aimed to investigate the usefulness of CEH-EUS-guided FNA/FNB sampling without on-site cytopathology. METHODS: Patients with SPLs were prospectively enrolled and randomly assigned (1:1) to 2 parallel groups, the interventional group (CEH-EUS) or the control group (conventional EUS). The diagnostic sensitivity and optimal number of needle passes for pathologic diagnosis were investigated and compared between groups. RESULTS: Two hundred forty patients were enrolled from March 2016 to September 2019, with 120 patients assigned to each group. Pancreatic malignancies and neuroendocrine tumors were found in 202 (90.83%) and 9 (3.75%) patients, respectively. There was no statistically significant difference between the groups in terms of age, sex, lesion size (30.96 ± 12.09 mm in the CEH-EUS group vs 33.09 ± 16.39 mm in the conventional EUS group; P = .252), lesion location, adverse event rate, and disease distribution. The diagnostic sensitivity values in the CEH-EUS and conventional EUS groups were 85.8% and 88.3%, respectively (P = .564). All patients in the conventional EUS group and most in the CEH-EUS group received a pathologic diagnosis within 3 needle passes. CONCLUSIONS: Diagnostic sensitivity for SPLs was not different between the CEH-EUS and conventional EUS groups, and no independent factors were found that could improve diagnostic sensitivity. CEH-EUS-guided FNA/FNB sampling does not need to be used routinely and may be selectively considered for small, indeterminate lesions. (Clinical trial registration number: KCT 0001840.).

Diagnostic performance of endoscopic ultrasound-artificial intelligence using deep learning analysis of gallbladder polypoid lesions.

BACKGROUND AND AIM: Endoscopic ultrasound (EUS) is the most accurate diagnostic modality for polypoid lesions of the gallbladder (GB), but is limited by subjective interpretation. Deep learning-based artificial intelligence (AI) algorithms are under development. We evaluated the diagnostic performance of AI in differentiating polypoid lesions using EUS images. METHODS: The diagnostic performance of the EUS-AI system with ResNet50 architecture was evaluated via three processes: training, internal validation, and testing using an AI development cohort of 1039 EUS images (836 GB polyps and 203 gallstones). The diagnostic performance was verified using an external validation cohort of 83 patients and compared with the performance of EUS endoscopists. RESULTS: In the AI development cohort, we developed an EUS-AI algorithm and evaluated the diagnostic performance of the EUS-AI including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. For the differential diagnosis of neoplastic and non-neoplastic GB polyps, these values for EUS-AI were 57.9%, 96.5%, 77.8%, 91.6%, and 89.8%, respectively. In the external validation cohort, we compared diagnostic performances between EUS-AI and endoscopists. For the differential diagnosis of neoplastic and non-neoplastic GB polyps, the sensitivity and specificity were 33.3% and 96.1% for EUS-AI; they were 74.2% and 44.9%, respectively, for the endoscopists. Besides, the accuracy of the EUS-AI was between the accuracies of mid-level (66.7%) and expert EUS endoscopists (77.5%). CONCLUSIONS: This newly developed EUS-AI system showed favorable performance for the diagnosis of neoplastic GB polyps, with a performance comparable to that of EUS endoscopists.

Clinical features and outcomes of hypertriglyceridemia-induced acute pancreatitis: Propensity score matching analysis from a prospective acute pancreatitis registry.

BACKGROUND: Hypertriglyceridemia (HTG) is a well-known cause of acute pancreatitis (AP) and elevation of serum triglycerides (TG) to ≥1000 mg/dl is strongly indicative of HTG-induced AP (HTG-AP). HTG-AP is potentially associated with persistent organ failure and poor prognosis. Here, we compared differences in clinical features and outcomes between patients with HTG-AP and patients with AP due to other causes. METHODS: A prospective AP registry was constructed in Gil Medical Center between June 2014 and May 2018. In total, 499 patients with AP were included for whom serum TG data at admission were available. RESULTS: HTG-AP was present in 52 patients (10.4%); these patients were younger than patients with AP due to other causes (39.62 ± 10.12 vs. 51.62 ± 17.41, p < 0.001). After propensity score matching adjusted by age, the factors associated with severity were more common in the HTG-AP group; these factors included the presence of systemic inflammatory response syndrome, Ranson's score ≥3, acute physiology, age, chronic health evaluation (APACHE) II score ≥8 at admission, and C-reactive protein level >10 mg/dl after 24 h of hospitalization. There were no significant differences in complications or severity based on the revised Atlanta classification 2012. In addition, recurrence was more frequent in the HTG-AP group (25.0% vs. 6.4%, p < 0.001). CONCLUSION: HTG-AP occurred in younger patients and showed more frequent recurrences than AP with other causes. Although factors related to severe feature were more common in HTG-AP during early phase, overall severity and prognosis were not different between the two groups.

Stenting as a bridge to surgery for extra-colonic malignancy induced colorectal obstruction: preliminary experience.

BACKGROUND: The majority of colonic obstructions result from colorectal cancer. However, malignancies of extra-colonic origin can also disrupt colorectal patency, and the efficacy of self-expanding metal stents (SEMS) insertion as a bridge to surgery in these patients are still in debate. The aim of this study is to evaluate the efficacy of endoscopic stenting as a bridge to surgery (BTS) for extra-colonic malignancy (ECM)-induced colonic obstruction. METHODS: Thirty-three patients with colonic obstruction due to ECM who received self-expanding metal stents (SEMS) insertion at a single academic tertiary medical center between 2004 and 2015 were included. The purpose of SEMS insertion was determined based on whether the patient's medical records indicated any surgical plans before SEMS insertion. Technical success was defined as a patent SEMS covering the entire length of the obstruction. Bridging success was defined as elective surgical procedures after the first SEMS insertion. RESULTS: Among the 33 patients who underwent SEMS insertion for colorectal obstruction due to ECM, nine underwent SEMS as a BTS. Technical success was achieved in 100% (9/9). Seven patients underwent elective surgery after successful decompression with the first SEMS, and the bridging success rate was 77.8% (7/9). Two patients needed secondary stent insertion before elective surgery. However, none of them required emergent surgery. No major complications occurred, including death related to colorectal endoscopic procedures, perforation, or bleeding. CONCLUSION: SEMS insertion as a BTS is a good treatment option to avoid emergent surgery in patients with colonic obstruction caused by extra-colonic malignancy.

NRF2 Knockdown Resensitizes 5-Fluorouracil-Resistant Pancreatic Cancer Cells by Suppressing HO-1 and ABCG2 Expression.

Chemoresistance is a leading cause of morbidity and mortality in patients with pancreatic cancer and remains an obstacle to successful treatment. The antioxidant transcription factor nuclear factor (erythroid-derived 2)-related factor 2 (NRF2), which plays important roles in tumor angiogenesis and invasiveness, is upregulated in pancreatic ductal adenocarcinoma (PDAC), where it correlates with poor survival. Here, we investigated the role of NRF2 in two 5-Fluourouracil-resistant (5-FUR) PDAC cell lines: BxPC-3 and CFPAC-1. Levels of NRF2 and antioxidants, such as heme oxygenase 1 (HO-1), NAD(P)H quinone dehydrogenase 1 (NQO1), and superoxide dismutase 2 (SOD2), were higher in the chemoresistant cells than in their chemosensitive counterparts. Expression of epithelial mesenchymal transition (EMT) markers, stemness markers, including Nanog, Oct4, and CD133, and that of the drug transporter ATP binding cassette, subfamily G, member A2 (ABCG2) was also upregulated in 5-FUR PDAC cells. NRF2 knockdown reversed 5-FU resistance of PDAC cells via suppression of ABCG2 and HO-1. In summary, these data indicate that NRF2 is a potential target for resensitizing 5-FUR PDAC cells to 5-FU to improve treatment outcomes in patients with pancreatic cancer.

Autologous blood, a novel agent for preoperative colonic localization: a safety and efficacy comparison study.

BACKGROUND: Preoperative localization is essential for minimally invasive colorectal surgery. However, conventional endoscopic tattooing agents such as India ink have safety issues. The availability of new endoscopic markers such as non-India-ink-based agent is limited. We assessed the efficacy and safety of preoperative endoscopic tattooing using autologous blood in colorectal surgery. METHODS: From February 2016, all patients who required localization of a target lesion before colorectal surgery underwent endoscopic tattooing using autologous blood, and the outcomes were collected prospectively. As a comparison, we retrospectively reviewed the medical records of a further 51 consecutive patients who underwent endoscopic tattooing using India ink before February 2016. A total of 102 patients who underwent endoscopic tattooing using either India ink or autologous blood were included in this study. The primary outcomes were the visibility of the tattooing in the peritoneal cavity and related adverse events. RESULTS: Endoscopic tattoos produced using India ink were visible in 49 (96.1%) patients, and tattoos created using autologous blood were visible in 47 (92.2%) patients. In the autologous blood group, the tattoo could not be identified in four patients due to excessive peritoneal fat, bleeding tendency, congenital anomaly, and suboptimal tattooing. Seven (13.7%) patients in the India ink group and three (5.9%) patients in the autologous blood group experienced endoscopic tattooing-related adverse events. CONCLUSIONS: Autologous blood is a feasible and safe tattooing agent for preoperative endoscopic localization of colorectal lesions within maximal interval of 5 days.

Long-term results of temperature-controlled endobiliary radiofrequency ablation in a normal swine model.

BACKGROUND AND AIMS: Endobiliary radiofrequency ablation (EB-RFA) is a new adjunctive method for biliary drainage restoration. However, a concern remains about long-term adverse events of this procedure, such as biliary stricture, perforation, and hemorrhage. Therefore, we aimed to assess the long-term effects of in vivo EB-RFA in a swine model. METHODS: Six mini-pigs were divided into 2 groups: 10-W/33-mm EB-RFA and 7-W/18-mm EB-RFA. Endoscopic retrograde cholangiography-guided temperature controlled EB-RFA (80°C, 7-10 W, 120 seconds) was performed. After 28 days all mini-pigs underwent follow-up ERC and were killed to assess the long-term effects of EB-RFA. RESULTS: All mini-pigs developed biliary stricture (median length, 10.5 mm; range, 6-15) with jaundice (total bilirubin, 5.84 mg/dL; range, 4.3-9.2) and purulent bile at 1 month after EB-RFA. A significant difference was found in the length of stricture on cholangiogram between the 10 W/33-mm and 7 W/18-mm EB-RFA groups (median, 14 vs 6 mm; P = .034); however, no differences were found in the width of the stricture and laboratory findings. Histologic examination revealed marked thickening of bile duct with severe damage of whole layers replaced with reactive myofibroblastic proliferation, dense collagen laydown, chronic and acute inflammation, and fat necrosis. However, long-term adverse events, such as perforation or hemorrhage, were not found. CONCLUSIONS: As a long-term result of EB-RFA, segmental biliary stricture with cholangitis develops in proportion to the power/length of the RFA electrode. Therefore, biliary stents should be placed to maintain biliary drainage after EB-RFA.

The efficacy of real-time colour Doppler flow imaging on endoscopic ultrasonography for differential diagnosis between neoplastic and non-neoplastic gallbladder polyps.

OBJECTIVES: We evaluated the usefulness of real-time colour Doppler flow (CDF) endoscopic ultrasonography (EUS) for differentiating neoplastic gallbladder (GB) polyps from non-neoplastic polyps. METHODS: Between August 2014 and December 2016, a total of 233 patients with GB polyps who underwent real-time CDF-EUS were consecutively enrolled in this prospective study. CDF imaging was subjectively categorized for each patient as: strong CDF pattern, weak CDF pattern and no CDF pattern. RESULTS: Of the 233 patients, 115 underwent surgical resection. Of these, there were 90 cases of non-neoplastic GB polyps and 23 cases of neoplastic GB polyps. In a multivariate analysis, a strong CDF pattern was the most significant predictive factor for neoplastic polyps; sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 52.2 %, 79.4 %, 38.7 %, 86.9 % and 73.9 %, respectively. Solitary polyp and polyp size were associated with an increased risk of neoplasm. CONCLUSIONS: The presence of a strong CDF pattern as well as solitary and larger polyps on EUS may be predictive of neoplastic GB polyps. As real-time CDF-EUS poses no danger to the patient and requires no additional equipment, it is likely to become a supplemental tool for the differential diagnosis of GB polyps. KEY POINTS: • Differential diagnosis between neoplastic polyps and non-neoplastic polyps of GB is limited. • The use of real-time CDF-EUS was convenient, with high agreement between operators. • The real-time CDF-EUS is helpful in differential diagnosis of GB polyps.

Endoscopic botulinum toxin injection for treatment of pharyngeal dysphagia in patients with cricopharyngeal dysfunction.

BACKGROUND: Dysphagia associated with neurologic disorders is a problem worldwide. However, few studies have assessed the efficacy of endoscopic botulinum toxin injections into the cricopharyngeal muscle using a pharyngoscope. METHODS: Fourteen patients who received an endoscopic botulinum toxin injection due to cricopharyngeal muscle dysfunction and a neurological disorder from 2006 to 2017 were retrospectively reviewed at a single tertiary medical center. The toxin was injected at a 100 international unit (IU) total dose under direct endoscopic vision. The success of the procedure was evaluated comprehensively using the following: clinical resolution of the previous symptoms, functional oral intake scale (FOIS) for the clinical evaluation of swallowing, and videofluoroscopic swallowing study (VFSS) to check decreased retention of barium at the pyriform sinus and the epiglottic vallecula. RESULTS: The study included 12 males and 2 females (mean age, 58 years old; range, 37-82 years). Three patients (21.4%) were confirmed clinically and eleven were confirmed by VFSS. Eleven patients (78.6%) were managed successfully with the injection. Three patients (21.4%) did not improve despite the injection. CONCLUSION: An endoscopic botulinum toxin injection may be a good treatment option for patients with dysphagia and cricopharyngeal dysfunction due to a neurological disorder. Large, prospective, long-term follow-up studies are needed in the future.

Safety and efficacy of glycopyrrolate as a premedication for endoscopic submucosal dissection: a randomized, double-blind, placebo-controlled study.

Background and study aims Anticholinergic premedication has not been validated for endoscopic submucosal dissection (ESD). In this randomized, double-blind, placebo-controlled trial, we investigated the efficacy and safety of glycopyrrolate as a premedication for ESD. Methods A total of 196 patients undergoing ESD at a single tertiary medical center between December 2014 and February 2016 were randomly allocated to receive one of the following two premedications: glycopyrrolate (0.004 mg/kg intramuscularly [IM]) or placebo (2.0 mL normal saline solution IM). All patients received the premedication 30 minutes prior to ESD in a double-blind manner. The endoscopists reported the ease of performing the procedure and the incidence of secretion-induced hypoxemia, cough, and other procedure-related adverse events. Results Glycopyrrolate and placebo were received by 96 and 100 patients, respectively. ESD was successfully performed in all patients without any serious adverse events related to sedation or ESD. The median visual analog scale for procedure ease was higher in the glycopyrrolate group at 8 (interquartile range [IQR] 7 - 9) vs. 7 (IQR 6 - 8.25); P < 0.001. The proportions of patients with secretion-induced hypoxemia (4.4 % vs. 14.3 %; P = 0.03) and cough (16.7 % vs. 35.7 %; P = 0.005) were lower in the glycopyrrolate group.  Conclusions The use of glycopyrrolate as a premedication for ESD significantly improved the ease of performing the procedure and reduced the incidence of secretion-induced hypoxemia and cough during ESD. Glycopyrrolate may be a promising premedication to ensure safe and stable ESD procedures. TRIAL REGISTRATION: Clinical Research Information Service (CRIS): KCT0001540.

Diagnostic efficacy of quantitative endoscopic ultrasound elastography for differentiating pancreatic disease.

BACKGROUND AND AIM: Endoscopic ultrasound elastography (EUS-EG) constitutes a novel imaging procedure that allows for the quantification of tissue stiffness with high degrees of accuracy in pancreatic disease. However, the optimal cut-off and reference strain ratio (SR) value of quantitative EUS-EG for differential diagnosis in patients with pancreatic disease remains unclear. This study aimed to clarify these values of normal pancreas, chronic pancreatitis, or pancreatic cancer in an Asian population. METHODS: Between December 2014 and November 2015, 398 patients without pancreatic disease, 67 patients with chronic pancreatitis, and 90 patients with pancreatic cancer who underwent EUS were enrolled prospectively. Elastographic evaluation was measured using the quotient B/A (SR value). RESULTS: The mean SR was 3.78 ± 1.35 for normal pancreas, 8.21 ± 5.16 for chronic pancreatitis, and 21.80 ± 12.23 for pancreatic cancer (P < 0.001). The median SR was 15.14 for mass-forming pancreatitis and 18.00 for pancreatic cancer (P = 0.024). The sensitivity, specificity, and accuracy of the SR were 71.6%, 75.2%, and 74.8%, respectively, for detecting chronic pancreatitis using a cut-off value of 5.62, and were 95.6%, 96.3%, and 96.2%, respectively, for detecting pancreatic cancer using a cut-off value of 8.86. CONCLUSIONS: We provided reference range SR values for normal pancreas, chronic pancreatitis, and pancreatic cancer, as well as an optimal cut-off value for chronic pancreatitis and pancreatic cancer diagnostic accuracy in an Asian population. Quantitative EUS-EG is a supplementary diagnostic method for identifying pancreatic disease.