K-ras mutation detected by peptide nucleic acid-clamping polymerase chain reaction, Ki-67, S100P, and SMAD4 expression can improve the diagnostic accuracy of inconclusive pancreatic EUS-FNB specimens.

OBJECTIVES: We aimed to assess the diagnostic utility of an immunohistochemical panel including calcium-binding protein P, p53, Ki-67, and SMAD family member 4 and K-ras mutation for diagnosing pancreatic solid lesion specimens obtained by endoscopic ultrasound-guided fine-needle biopsy and to confirm their usefulness in histologically inconclusive cases. METHODS: Immunohistochemistry and peptide nucleic acid-clamping polymerase chain reaction for K-ras mutation were performed on 96 endoscopic ultrasound-guided fine-needle biopsy specimens. The diagnostic efficacy of each marker and the combination of markers was calculated. The diagnostic performances of these markers were evaluated in 27 endoscopic ultrasound-guided fine-needle biopsy specimens with histologically inconclusive diagnoses. A classification tree was constructed. RESULTS: K-ras mutation showed the highest accuracy and consistency. Positivity in more than two or three of the five markers showed high diagnostic accuracy (94.6 % and 93.6 %, respectively), and positivity for more than three markers showed the highest accuracy for inconclusive cases (92.0 %). A classification tree using K-ras mutation, Ki-67, S100P, and SMAD4 showed high diagnostic performance, with only two misclassifications in inconclusive cases. CONCLUSIONS: K-ras mutation detection via peptide nucleic acid-clamping polymerase chain reaction is a stable and accurate method for distinguishing between pancreatic ductal adenocarcinoma and non-pancreatic ductal adenocarcinoma lesions. A classification tree using K-ras mutation, Ki-67, S100P, and SMAD4 helps increase the diagnostic accuracy of cases that are histologically difficult to diagnose.

Clinical impact of pancreatic steatosis measured by CT on the risk of post-ERCP pancreatitis: a multicenter prospective trial.

BACKGROUND AND AIMS: Pancreatic steatosis (PS) may be a risk factor for acute pancreatitis. Whether it is also a risk factor for post-ERCP pancreatitis (PEP) has not been evaluated. This study aimed to determine the impact of PS on PEP development. METHODS: This multicenter prospective trial enrolled 786 consecutive patients who underwent contrast-enhanced abdominal CT and subsequent first-time ERCP. PS was evaluated based on pancreatic attenuation on unenhanced CT images. The risk of PS for the development of PEP was evaluated using a logistic regression model. RESULTS: Of 527 patients included in the study, 157 (29.8%) had PS and 370 (70.2%) did not. At 24 hours after ERCP, there was a significant difference in the PEP identified in 22 patients (14.0%) in the PS group and 23 patients (6.2%) in the "no PS" (NPS) group (P = .017). Diabetes and hypertension were more common in the PS group than in the NPS group; no differences in dyslipidemia were found. Patients with PS had a higher risk for the development of PEP than those with NPS (odds ratio, 2.09; 95% confidence interval, 1.08-4.03). No other variables were identified as risk factors for PEP. CONCLUSIONS: PS is a significant risk factor for PEP for which preventive measures should be considered. Standardized measurement protocols to assess PS by CT are needed. (Clinical trial registration number: KCT0006068.).

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.

A comparison of novel electrocautery-enhanced lumen-apposing metal stents and plastic stents in EUS-guided drainage of infected walled-off necrosis: A multicenter randomized study.

BACKGROUND AND STUDY AIMS: Although lumen-apposing metal stents (LAMSs) have been increasingly used for walled-off necrosis (WON), their advantages over plastic stents (PS) in infected WON are unclear. We investigated the safety and efficacy of novel electrocautery-enhanced LAMS (EC-LAMS) for managing infected WON. PATIENTS AND METHODS: Patients who underwent endoscopic ultrasound-guided WON drainage were randomly assigned to the LAMS or PS groups. The primary outcome was the total number of direct endoscopic necrosectomy (DEN) procedures required to achieve clinical success. The secondary outcomes included technical success, clinical success, and adverse event occurrence. RESULTS: Forty-six patients were divided into the LAMS or PS groups (n=23 each). The total number of DEN procedures did not differ significantly between the PS (four procedures, interquartile range [IQR] 2.5-5.0) and LAMS groups (nine procedures, IQR: 8.0-9.0) (P=0.07). The LAMS group demonstrated a significantly higher clinical success rate than the PS group based on intention-to-treat analysis (100% vs. 73.9%, P=0.03) at 8 weeks but not at 4 weeks. No significant bleeding events were reported in the LAMS group, and one was reported in the PS group. CONCLUSIONS: We found no significant difference in the total number of DEN procedures between LAMS and PS for managing infected WON. The only statistically significant finding was a higher clinical success rate at 8 weeks for patients treated with EC-LAMS. The use of EC-LAMS did not result in any adverse events, such as bleeding or buried LAMS syndrome, within the study duration.

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.).

Comparison of the long-term outcomes between proximal and distal IgG4-related sclerosing cholangitis: A multicenter cohort study.

BACKGROUND AND AIMS: Immunoglobulin G4-related sclerosing cholangitis (IgG4-SC) is considered a biliary manifestation of IgG4-related diseases. However, there has been a controversy on the clinical outcomes according to the location of the involved bile duct. We therefore compared the clinical outcomes and long-term prognosis of IgG4-SC with proximal bile duct involvement (proximal IgG4-SC) and IgG4-SC with distal bile duct involvement (distal IgG4-SC). METHODS: We reviewed the data of patients with IgG4-SC that were prospectively collected at 10 tertiary centers between March 2002 and October 2020. Clinical manifestations, outcomes, association with autoimmune pancreatitis (AIP), steroid-responsiveness, and relapse of IgG4-SC were evaluated. RESULTS: A total of 148 patients (proximal IgG4-SC, n = 59; distal IgG4-SC, n = 89) were analyzed. The median age was 65 years (IQR, 56.25-71), and 86% were male. The two groups were similar in terms of jaundice at initial presentation (51% vs 65%; P = 0.082) and presence of elevated serum IgG4 (66% vs 70%; P = 0.649). The two groups showed significant differences in terms of steroid-responsiveness (91% vs 100%; P = 0.008), association with AIP (75% vs 99%; P = 0.001), and occurrence of liver cirrhosis (9% vs 1%; P = 0.034). During a median follow-up of 64 months (IQR, 21.9-84.7), the cumulative relapse-free survival was significantly different between the two groups (67% vs 79% at 5 years; P = 0.035). CONCLUSIONS: Relapse of IgG4-SC frequently occurred during follow-up. Proximal IgG4-SC and distal IgG4-SC had different long-term outcomes in terms of steroid-responsiveness, occurrence of liver cirrhosis, and recurrence. It may be advantageous to determine the therapeutic and follow-up strategies according to the location of bile duct involvement.

Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial.

BACKGROUND : Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy. METHODS : Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding. RESULTS : The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1-47.5] vs. 15.0 % [95 %CI 7.1-29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7-31.9] vs. 5.3 % [95 %CI 1.5-17.3]), and all cases were mild. CONCLUSIONS : Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.

Impact of pancreatic fat on the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND AND STUDY AIMS: Fatty pancreas is a potential risk factor for acute pancreatitis; however, whether it is also a risk factor for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been evaluated. We aimed to determine the impact of fatty pancreas on the development of PEP. METHODS: We analyzed the data of patients who underwent abdominal computed tomography (CT) scan and sequential therapeutic endoscopic retrograde cholangiopancreatography (ERCP). Fatty change in the pancreas was evaluated based on pancreatic attenuation of unenhanced image on CT scan. The risk of fatty pancreas for the development of PEP was evaluated using a logistic regression model. RESULTS: Of a total of 858 patients included in the study, 354 (41.3%) had fatty pancreas, while 504 (58.7%) did not have fatty pancreas. PEP developed in 28 patients (7.9%) in the fatty pancreas group and in 13 patients (2.6%) in the no fatty pancreas group. Fatty pancreas was significantly associated with the development of PEP (odds ratio [OR] [95% confidence interval [CI]] 2.38 [1.16-4.87]). A history of acute pancreatitis, female sex, difficult cannulation, and endoscopic papillary balloon dilation were also risk factors for the development of PEP. The risk for moderate-to-severe PEP development tended to be higher in the fatty pancreas group than in the no fatty pancreas group (OR [95% CI] 5.61 [0.63-49.62]). CONCLUSIONS: Fatty pancreas is a significant risk factor for the development of PEP. Clinicians need to be aware of the risk of fatty pancreas for the development of PEP prior to performing ERCP.

Pre- and post-procedure risk prediction models for post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common serious adverse event. Given recent endoscopic advances, we aimed to develop and validate a risk prediction model for PEP using the latest clinical database. METHODS: We analyzed the data of patients with naïve papilla who underwent endoscopic retrograde cholangiopancreatography (ERCP). Pre-ERCP and post-ERCP risk prediction models for PEP were developed using logistic regression analysis. Patients were classified into low- (0 points), intermediate- (1-2 points), and high-risk (≥ 3 points) groups according to point scores. RESULTS: We included 760 and 735 patients in the derivation and validation cohorts, respectively. The incidence of PEP was 5.5% in the derivation cohort and 3.9% in the validation cohort. Age ≤ 65 (1 point), female sex (1 point), acute pancreatitis history (2 points), malignant biliary obstruction (2 points [pre-ERCP model] or 1 point [post-ERCP model]), and pancreatic sphincterotomy (2 points, post-ERCP model only) were independent risk factors. In the validation cohort, the high-risk group (≥ 3 points) had a significantly higher risk of PEP compared to the low- or intermediate-risk groups under the post-ERCP risk prediction model (low: 2.0%; intermediate: 3.4%; high: 18.4%), while there was no significant between-group difference under the pre-ERCP risk prediction model (low: 2.2%; intermediate: 3.8%; high: 6.9%). CONCLUSIONS: We developed and validated pre-ERCP and post-ERCP risk prediction models. In the latter, the high-risk group had a higher risk of PEP development than the low- or intermediate-risk groups. Our study findings will help clinicians stratify patient risk for the development of PEP.

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.

Mechanistic loop resolution strategy for short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y reconstruction after gastrectomy (with video).

BACKGROUND: Endoscopic access to the targeted site is a major challenge for the endoscopic retrograde cholangiopancreatography (ERCP) in patients undergoing Roux-en-Y (R-Y) reconstruction after total or subtotal gastrectomy. We aimed to evaluate the feasibility, reproducibility, and safety of mechanistic loop resolution strategies using a short-type single-balloon enteroscopy (short SBE) system. METHODS: Between February 2020 and March 2022, consecutive patients with a previous R-Y gastrectomy requiring ERCP were prospectively enrolled. Different mechanistic loop resolution strategies for two-dimensional loops, three-dimensionally rotated loops, and loops making a cane or S-shape were applied during the SBE approach. RESULTS: Forty-three short SBE-ERCP procedures were performed on 37 patients, with an approach success rate of 100.0% (43/43). The mean time to reach the jejunojejunal anastomosis and target site were 8.0 (6.0-11.0) minutes and 26.0 (16.0-36.0) minutes, respectively. The major challenges for the approach were the cane or S-shaped loop in the jejunojejunal anastomosis or Treitz ligament. The retroflex positioning of a SBE in front of the papilla was achieved in 86.0% (37/43), and the cannulation success rate in patients with an intact papilla was 90.9% (30/33). The initial, overall therapeutic successes, median total procedure time, and adverse event rate were 87.8%, 92.7%, 77.0 (IQR 56-100.5) minutes, and 11.6%, respectively. CONCLUSIONS: Short SBE-ERCP using standardized mechanistic loop resolution strategies is effective and reproducible in patients with R-Y reconstruction after gastrectomy. TRIAL REGISTRATION: ClinicalTrial.gov (NCT04847167).

Current status of endoscopic management of cholecystitis.

Laparoscopic cholecystectomy remains the standard treatment for acute cholecystitis (AC) although it is always not suitable for patients who are poor candidates for surgery. Recently, endoscopic gallbladder (GB) drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms, definitive treatment, or bridging therapy until surgery is possible. Two endoscopic methods have been established using either the trans-mural or trans-papillary drainage approach. Endoscopic ultrasound-guided GB drainage (EUS-GBD; trans-mural approach) is a novel technique that allows stent placement between the GB and duodenum or stomach via fistula track, effectively enabling GB drainage. For endoscopic trans-papillary GB drainage (ETGBD; trans-papillary approach), attempts of selective cannulation to the cystic duct should be made to place the stent in the same manner as an endoscopic retrograde cholangiopancreatography. In comparison, EUS-GBD has higher clinical success and lower recurrence rates than ETGBD due to the use of larger-caliber stents, which allow for effective drainage when performed by skilled practitioners at high-volume centers. Advantages of ETGBD over EUS-GBD include more affordable costs and physiologic drainage, which preserves naive anatomy for possible future cholecystectomy. Although the field of endoscopic treatment for AC is rapidly advancing, important questions regarding which method improves clinical outcomes and safety more effectively remain unaddressed. Herein, the current status of endoscopic treatment for AC, including a technical review on clinical outcomes, adverse events, and advantages and disadvantages of each technique are reviewed, as well as other future prospects.

Ursodeoxycholic acid shows antineoplastic effects in bile duct cancer cells via apoptosis induction; p53 activation; and EGFR-ERK, COX-2, and PI3K-AKT pathway inhibition.

Unlike in normal cells, ursodeoxycholic acid (UDCA) causes apoptosis rather than protection in cancer cells. Aim of this study was to demonstrate whether UDCA actually inhibits proliferation and induces apoptosis in bile duct cancer cells; the effect of UDCA on the expression of COX-2, PI3K/AKT, ERK, and EGFR; how UDCA affects cancer cell invasiveness and metastasis, since these effects are not established in bile duct cancer cells. SNU-245 cells (human extrahepatic bile duct cancer cells) were cultured. MTT assays were performed to evaluate the effect of UDCA on the cell proliferation. A cell death detection enzyme-linked immunosorbent assay and a caspase-3 activity assay were used to determine apoptosis. Western blot analysis measured expression levels of various proteins. The invasiveness of the cancer cells was evaluated by invasion assay. In cultured bile duct cancer cells, UDCA suppressed cell proliferation in bile duct cancer cells by inducing apoptosis and p53 activation, blocking deoxycholic acid (DCA)-induced activated EGFR-ERK signaling and COX-2, inhibiting DCA-induced activated PI3K-AKT signaling, and suppressing the invasiveness of bile duct cancer cells. In addition, a MEK inhibitor impaired UDCA-induced apoptosis in bile duct cancer cells. UDCA has antineoplastic and apoptotic effects in bile duct cancer cells. Thus, UDCA could be a chemopreventive agent in patients with a high risk of cancer, and/or a therapeutic option that enhances other chemotherapeutics.

Efficacy of an artificial neural network algorithm based on thick-slab magnetic resonance cholangiopancreatography images for the automated diagnosis of common bile duct stones.

BACKGROUND AND AIM: Magnetic resonance cholangiopancreatography (MRCP) can accurately diagnose common bile duct (CBD) stones but is laborious to interpret. We developed an artificial neural network (ANN) capable of automatically assisting physicians with the diagnosis of CBD stones. This study aimed to evaluate the ANN's diagnostic performance for detecting CBD stones in thick-slab MRCP images and identify clinical factors predictive of accurate diagnosis. METHODS: The presence of CBD stones was confirmed via direct visualization through endoscopic retrograde cholangiopancreatography (ERCP). The absence of CBD stones was confirmed by either a negative endoscopic ultrasound accompanied by clinical improvements or negative findings on ERCP. Our base networks were constructed using state-of-the-art EfficientNet-B5 neural network models, which are widely used for image classification. RESULTS: In total, 3156 images were collected from 789 patients. Of these, 2628 images from 657 patients were used for training. An additional 1924 images from 481 patients were prospectively collected for validation. Across the entire prospective validation cohort, the ANN achieved a sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of 93.03%, 97.05%, 97.01%, 93.12%, and 95.01%, respectively. Similarly, a radiologist achieved a sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy 91.16%, 93.25%, 93.22%, 90.20%, and 91.68%, respectively. In multivariate analysis, only bile duct diameter > 10 mm (odds ratio = 2.45, 95% confidence interval [1.08-6.07], P = 0.040) was related to ANN diagnostic accuracy. CONCLUSION: Our ANN algorithm automatically and quickly diagnoses CBD stones in thick-slab MRCP images, therein aiding physicians with optimizing clinical practice, such as whether to perform ERCP.

Bedside risk-scoring model for predicting 6-week mortality in cirrhotic patients undergoing endoscopic band ligation for acute variceal bleeding.

BACKGROUND AND AIM: Acute variceal bleeding (AVB) is a fatal adverse event of cirrhosis, and endoscopic band ligation (EBL) is the standard treatment for AVB. We developed a novel bedside risk-scoring model to predict the 6-week mortality in cirrhotic patients undergoing EBL for AVB. METHODS: Cox regression analysis was used to assess the relationship of clinical, biological, and endoscopic variables with the 6-week mortality risk after EBL in a derivation cohort (n = 1373). The primary outcome was the predictive accuracy of the new model for the 6-week mortality in the validation cohort. Moreover, we tested the adequacy of the mortality risk-based stratification and the discriminative performance of our new model in comparison with the Child-Turcotte-Pugh (CTP) and the model for end-stage liver disease scores in the validation cohort (n = 200). RESULTS: On multivariate Cox regression analysis, five objective variables (use of beta-blockers, hepatocellular carcinoma, CTP class C, hypovolemic shock at initial presentation, and history of hepatic encephalopathy) were scored to generate a 12-point risk-prediction model. The model stratified the 6-week mortality risk in patients as low (3.5%), intermediate (21.1%), and high (53.4%) (P < 0.001). Time-dependent area under the receiver operating characteristic curve for 6-week mortality showed that this model was a better prognostic indicator than the CTP class alone in the derivation (P < 0.001) and validation (P < 0.001) cohorts. CONCLUSIONS: A simplified scoring model with high potential for generalization refines the prediction of 6-week mortality in high-risk cirrhotic patients, thereby aiding the targeting and individualization of treatment strategies for decreasing the mortality rate.

Identification of risk factors for obstructive cholecystitis following placement of biliary stent in unresectable malignant biliary obstruction: a 5-year retrospective analysis in single center.

BACKGROUND: The risk factors for acute cholecystitis following biliary stent placement in patients with malignant biliary obstruction (MBO) have not been identified. We determined these risk factors and the efficacy of endoscopic ultrasound (EUS)-guided gallbladder drainage (GBD) as treatment. METHODS: We retrospectively analyzed patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for MBO from October 2013 to September 2018, and those with unresectable MBO with intact gallbladder (GB) were enrolled. RESULTS: Acute cholecystitis occurred in 30 (15.7%) of 191 patients who underwent biliary stent placement for unresectable MBO. Logistic regression analysis confirmed that biliary stent across the orifice of the cystic duct (OCD) (odds ratio [OR] 6.02, 95% confidence interval [CI] 1.43-25.41, P = 0.015), GB opacification during ERCP (OR 13.07, 95% CI 4.22-40.50; P < 0.0001), and self-expandable metal stent (SEMS) (OR 14.19, 95% CI 4.36-46.18; P < 0.0001) were independent risk factors for cholecystitis. Subgroup analysis of patients who only underwent SEMS placement showed that biliary stent across the OCD and GB opacification were significant risk factors. Among the 25 patients who underwent EUS-GBD, the technical and clinical success rates were 100% and 96%, respectively. CONCLUSIONS: Biliary stent across the OCD, GB opacification, and SEMS were established as potential risk factors for post-ERCP cholecystitis. Thus, the strategy of using shorter stent length and avoiding unnecessary contrast injection could be a reasonable treatment option for selected patients with high risk of cholecystitis. Furthermore, EUS-GBD is not only safe and reliable for acute cholecystitis, but it also improves quality of life.

Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

OBJECTIVES: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. METHODS: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. RESULTS: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group. DISCUSSION: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.

Comparative efficacy of stents in endoscopic ultrasonography-guided peripancreatic fluid collection drainage: A systematic review and network meta-analysis.

BACKGROUND: Although many studies have reported the efficacy of different stents for endoscopic ultrasonography (EUS)-guided peripancreatic fluid collection (PFC) drainage, they have not completely determined which stent is superior. This network meta-analysis comprehensively evaluated the comparative efficacy of stents used in EUS-guided PFC. METHODS: We searched all relevant studies published up to February 2019 that examined the efficacy of double pigtail plastic stent (DPPS), fully covered self-expanding metal stent (FCSEMS), and lumen-apposing metal stent (LAMS) in EUS-guided PFC drainage. We performed a Bayesian network meta-analysis for clinical efficacy and adverse events. RESULTS: Fifteen studies comprising 1746 patients were included in the meta-analysis. In terms of clinical success, no significant differences were noted in LAMS versus DPPS or LAMS versus FCSEMS (risk ratio [RR] 1.04 [95% credible interval (CrI) 0.99-1.11] and RR 0.96 [95% CrI 0.91-1.03]), respectively). FCSEMS was superior in terms of clinical success to DPPS (RR 1.09, 95% CrI 1.02-1.15). There was no significant difference in the recurrence of PFC among groups. Regarding adverse events, LAMS had a higher bleeding risk than FCSEMS (RR 6.70, 95% CrI 1.77-36.27) and tended to have a higher risk of bleeding than DPPS (RR 2.67, 95% CI 0.71-9.28). In terms of stent migration, there was no significant difference between any two groups compared. CONCLUSIONS: FCSEMS had superior efficacy in terms of clinical success compared with DPPS stents. Significant superiority of LAMS to DPPS was not identified. Additionally, LAMS had the higher risk of bleeding than FCSEMS.

The diagnostic performance of novel torque technique for endoscopic ultrasound-guided tissue acquisition in solid pancreatic lesions: A prospective randomized controlled trial.

BACKGROUND AND AIM: Although several techniques for improved outcomes in endoscopic ultrasound (EUS)-guided tissue acquisition have been reported, the reported diagnostic yield for pancreatic masses is not satisfactory. The effects of novel technique (torque method) on twisting the scope in the clockwise or counterclockwise direction during EUS-fine needle biopsy (EUS-FNB) are unknown. We compared the diagnostic yield of EUS-FNB for pancreatic masses using the torque and standard techniques. METHODS: From April 20, 2017, to March 16, 2018, 124 consecutive patients with solid pancreatic mass who underwent EUS-FNB using either the torque or standard technique were randomly assigned. Three passes were made with each technique, comprising 10 uniform to-and-fro movements on each pass with a 10-mL syringe suction. The primary outcome was procurement rates of histologic cores, and the secondary outcomes were the diagnostic performance and technical failure. RESULTS: There were significant differences between the groups regarding the procurement rate of the histologic core and optimal quality core (standard vs torque: 87.1% [54/62] vs 98.4% [61/62], P = 0.038 and 79.0% [49/62] vs 93.5% [58/62], P = 0.037). The sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB were 85.45%, 100%, 100%, and 46.67%, respectively, for the standard technique and 96.49%, 100%, 100%, and 71.43%, respectively, for the torque technique. The diagnostic accuracies of the standard and torque techniques were 87.10% and 96.77%, respectively. CONCLUSIONS: The torque technique for EUS-FNB offered acceptable technical feasibility and superior diagnostic performance, including optimal histologic core procurement, compared with the standard technique.

Clinical outcomes of sedation during emergency endoscopic band ligation for variceal bleeding: Multicenter cohort study.

BACKGROUND AND AIMS: Few studies have directly compared the efficacy of sedated- and un-sedated endoscopic variceal ligation (EVL) for acute variceal bleeding. We aimed to determine whether sedation during EVL in patients with variceal bleeding is safe and effective. METHODS: We analyzed data from patients who underwent EVL for acute variceal bleeding according to sedation in six hospitals of Hallym University Medical Center. The primary endpoint was treatment failure, defined as a failure to control bleeding, death during EVL, or rebleeding within 5 days. Secondary endpoints included the procedure time, adverse events, and 30-day mortality. RESULTS: Of 1,300 patients who were included, only 430 (33.1%) received sedation during EVL. Propofol alone was used for sedation in 85% of sedated-EVLs. The mean procedure time in the sedation group was shorter than that of the non-sedation group (12.4 ± 9.5 min versus 13.8 ± 9.4 min, P = 0.010). The proportion of treatment failure did not differ between the groups (7.4% versus 9.1%, P = 0.374). In the multivariable analysis, an AIMS65 score ≥2 and blood transfusion within 72 hours were associated with treatment failure of EVL; however, the use of sedation was not (odds ratio [95% confidence interval (CI)] = 0.96 [0.60-1.51]). Adverse events during EVL and hepatic encephalopathy did not differ between the two groups. Sedation also did not affect the 30-day mortality (hazard ratio [95% CI] = 0.99 [0.66-1.47]). CONCLUSION: Sedation reduced the procedure time of EVL. Sedation is safe to use during EVL for variceal bleeding in patients with cirrhosis.