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 EUS: a multicenter randomized controlled study.

BACKGROUND AND AIMS: Propofol, a widely used sedative in GI endoscopic procedures, is associated with cardiorespiratory suppression. Remimazolam is a novel ultrashort-acting benzodiazepine sedative with rapid onset and minimal cardiorespiratory depression. This study compared the safety and efficacy of remimazolam and propofol during 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 (AEs) during the procedure, including desaturation, respiratory depression, hypotension, and tachycardia. Secondary endpoints were the time to achieve sedation, recovery time, quality of sedation, pain at the injection site, and satisfaction of both 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 AEs, the remimazolam group experienced fewer occurrences than the propofol group (8.5% vs 16%, P = .022). A nonsignificant trend was found toward less oxygen desaturation (1.0% vs 3.5%, P = .09), respiratory depression (.5% vs 1.5%, P = .62), hypotension (2.5% vs 5.5%, P = .12), and tachycardia (4.5% vs 5.5%, P = .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. CONCLUSIONS: Remimazolam was superior to propofol in terms of safety and efficacy during EUS examinations. (Clinical trial registration number: KCT 0007643.).

Cholecystectomy Increases the Risk of Type 2 Diabetes in the Korean Population: Data From the National Health Insurance Cooperation Health Checkup 2010-2017.

OBJECTIVE: This study assessed whether cholecystectomy is a risk factor for newly developed type 2 diabetes mellitus (T2DM) in the Korean population. BACKGROUND: There is a lack of evidence that cholecystectomy is independently associated with insulin resistance and T2DM. METHODS: This study included all patients aged more than 20 years who had undergone cholecystectomy from 2010 to 2015 (n=55,166) and age-matched and sex-matched control subjects without cholecystectomy (n=110,332) using the National Health Insurance Service database. They were followed up until the date of newly developed T2DM or study end and the incidence of T2DM was traced over a maximum observation period of 7 years. RESULTS: Overall, 55,166 patients who underwent cholecystectomy and 110,332 age-matched and sex-matched controls were followed up for ∼4.7 years, during which, incident T2DM occurred in 5982 (3.61%) patients. Cholecystectomy was associated with 20% higher risk of T2DM after adjustment for all covariates. The cumulative incidence of T2DM also significantly increased in the cholecystectomy group for ∼7 years ( P <0.001). The adjusted hazard ratio (HR) for T2DM was the highest in the group with both cholecystectomy and obesity using the control without both cholecystectomy and obesity as a reference [HR=1.41, 95% confidence interval (CI): 1.29-1.56]. The group with cholecystectomy without obesity showed the comparable risk of incident T2DM compared with the group without cholecystectomy with obesity (HR=1.29, 95% CI: 1.20-1.40 for cholecystectomy without obesity and HR=1.24, 95% CI: 1.14-1.36 for control with obesity). CONCLUSIONS: These results provide evidence that cholecystectomy is associated with an increased risk of newly developed T2DM in the Korean population. Further research is required to elucidate the mechanism of the association between cholecystectomy and incident diabetes.

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.).

Efficacy analysis of hemostatic spray following endoscopic papillectomy: A multicenter comparative study.

BACKGROUND AND AIM: Endoscopic post-papillectomy bleeding is a serious adverse event with a prevalence ranging from 2% to 45.3%. Conventional hemostatic methods, including diluted epinephrine injection before papillectomy or argon plasma coagulation after papillectomy, did not show a preventive role in reducing immediate or delayed post-papillectomy bleeding. Therefore, we aimed to assess the efficacy and safety of a hemostatic powder spray for post-papillectomy bleeding and compare with those of conventional modalities. METHODS: Patients who underwent endoscopic papillectomy were enrolled in five tertiary hospitals. The group was divided into hemostatic spray and conventional control groups according to the bleeding control methods. The main outcome measurements were delayed bleeding rate and any adverse events related to the procedures. RESULTS: A total of 40 patients who received a hemostatic spray (n = 18) or conventional hemostatic methods (n = 22) after endoscopic papillectomy were included. The prevalence of delayed bleeding was not different in the two groups: 27.8% and 36.4% in hemostatic spray and conventional control groups (P = 0.564), respectively. The adverse events such as post-papillectomy pancreatitis and cholangitis were not different in the two groups. There were no procedure-related mortalities. CONCLUSION: Hemostatic spray is technically feasible and safe for the prevention or management of post-papillectomy bleeding. Hemostatic spray can be one of the options for post-papillectomy bleeding control methods owing to its convenient use.

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.

Acetylsalicylic acid for metal stent in malignant distal common bile duct obstruction: A randomized controlled trial.

BACKGROUND: Endoscopic biliary drainage is the treatment of choice for patients with malignant distal common bile duct obstruction. Self-expandable metal stents have clinical advantages including an increased duration of patency that may be prolonged by acetylsalicylic acid (ASA) use. The aim of this study was to investigate whether ASA had a positive effect on the patency of self-expandable metal stents compared with placebo. METHODS: This prospective, multicenter, double-blinded, and randomized placebo-controlled trial was conducted from October 2017 to May 2020 in Korea. Patients who underwent palliative endoscopic biliary drainage with self-expandable metal stents for malignant distal bile duct obstruction were enrolled, and allocated to ASA treatment or placebo. The study outcomes were the rate of stent dysfunction at 6 months, duration of stent patency, risk factors for stent dysfunction, and any adverse events. RESULTS: Interim analysis included 24 and 28 patients in the ASA and placebo groups, respectively. There was no significant difference between the ASA and placebo groups in stent dysfunction (25.0% vs. 20.7%, P = 0.761) or the duration of stent patency (150.97 ± 10.55 vs. 158.07 ± 8.70 days, P = 0.497). Six patients experienced suspected ASA-related adverse events, and there was one lethal case. CONCLUSIONS: ASA did not prolong stent patency. This study was terminated early because of the possibility of serious adverse events related to ASA treatment of these patients receiving palliative care.

Malignant potential of small pancreatic neuroendocrine neoplasm and its risk factors: A multicenter nationwide study.

BACKGROUND: Pancreatic neuroendocrine neoplasms (PNENs) show heterogeneous biological behavior, and most small PNENs show indolent features. Consequently, selected cases can be considered for observation only, according to the National Comprehensive Cancer Network guideline, however, supporting clinical evidence is lacking. We investigated the clinical course of small PNENs and their risk factors for malignant potential. METHODS: A total of 158 patients with small pathologically confirmed PNENs ≤2 cm in initial imaging were retrospectively enrolled from 14 institutions. The primary outcome was any metastasis or recurrence event during follow-up. RESULTS: The median age was 57 years (range, 22-82 years), and 86 patients (54%) were female. The median tumor size at initial diagnosis was 13 mm (range, 7-20 mm). PNENs were pathologically confirmed by surgery in 137 patients and by EUS-guided fine needle aspiration biopsy (EUS-FNAB) in 21 patients. Eight patients underwent EUS-FNAB followed by surgical resection. The results of WHO grade were available in 150 patients, and revealed 123 grade 1, 25 grade 2, and 2 neuroendocrine carcinomas. A total of 145 patients (92%) underwent surgical resection, and three patients had regional lymph node metastasis. During the entire follow-up of median 45.6 months, 11 metastases or recurrences (7%) occurred. WHO grade 2 (HR 13.97, 95% CI 2.60-75.03, p = 0.002) was the only predictive factor for malignant potential in multivariable analysis. CONCLUSIONS: WHO grade is responsible for the malignant potential of small PNENs ≤2 cm. Thus, EUS-FNAB could be recommended in order to provide early treatment strategies of small PNENs.

Triglyceride and glucose (TyG) index is an effective biomarker to identify severe acute pancreatitis.

BACKGROUND: Early diagnosis of severe acute pancreatitis (AP) is important to reduce morbidity and mortality. We investigated the association between the triglyceride and glucose index (TyG index) and the prognosis of severe AP (SAP). METHODS: The TyG index was calculated as: ln [fasting triglycerides (mg/dL) x fasting plasma glucose (mg/dL)]/2. Multivariable logistic regression analyses were used to investigate the independent association between the TyG index and the severity of AP. RESULTS: In this study, 373 patients with AP were recruited from three hospitals. The TyG index was higher in the SAP group than in the non-SAP group. Further, the TyG index was higher than in patients admitted to an intensive care unit and those who died of AP. The TyG index was an independent predictive factor for SAP (odds ratio 7.14, 95% confidence interval 2.80-18.19). The area under the curve increased significantly, from 0.738 to 0.830, after adding the TyG index to a predictive SAP model. CONCLUSIONS: Our findings suggest that the TyG index is an independent prognostic factor in patients with AP and could be used as a simple prognostic indicator for SAP.

Diabetes Mellitus is Associated With Mortality in Acute Pancreatitis.

BACKGROUND AND AIM: Predicting severe pancreatitis is important for early aggressive management of patients with acute pancreatitis (AP). Despite the established role of diabetes mellitus (DM) in the risk of AP, the impact of DM on the clinical outcome in AP has not been fully elucidated. The objective of this study was to assess the risk of mortality and severity in AP among patients with type-2 DM. METHODS: Patients diagnosed with first attacks of AP were enrolled from January 2013 to June 2015. RESULTS: A total of 201 patients (63.2% male, mean age, 59.4 y) with AP were included. Etiologies included gallstones (51.2%), alcohol (37.3%), hypertriglyceridemia (2%), and idiopathic causes (9.5%). There were 54 AP patients (26.9%) with type-2 DM. Severity indices in AP, such as Atlanta Classification (severe), Ranson score, and Bedside Index of Severity in Acute Pancreatitis, were higher in subjects with DM than those without DM. Prevalence of intensive care unit admission and mortality were higher in AP patients with DM compared with those without DM. The association between DM and increased risk of mortality in AP remained statistically significant even after adjustments for confounding factors and Atlanta Classification (odds ratio, 7.76, 95% confidence interval, 1.26-47.63, P=0.027). CONCLUSIONS: Type-2 DM was associated with severity and increased mortality in patients with AP. Our findings provide evidence of the potential role of DM in the pathogenesis and management of severe AP.

Neutrophil to lymphocyte ratio and platelet to lymphocyte ratio can predict the severity of gallstone pancreatitis.

BACKGROUND: Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) predict severity in various diseases. In this study, we evaluated the value of NLR and PLR as prognostic factors in acute pancreatitis (AP). METHODS: Patients with AP were prospectively enrolled from March 2014 to September 2016 at Yonsei University Wonju College of Medicine. NLR and PLR were obtained at admission and were compared with other known prognostic scoring systems. RESULTS: A total of 243 patients were enrolled with an etiology of gallstone (n = 134) or alcohol (n = 109). NLR (17.7 ± 18.3 vs. 8.8 ± 8.4, P <  0.001) and PLR (344.1 ± 282.6 vs. 177.8 ± 150.1, P <  0.001) were significantly higher in the gallstone AP group than in the alcoholic AP group. For gallstone AP, NLR and PLR were significantly higher in severe AP, whereas high NLR and PLR were not related to severe AP in alcoholic AP. For the gallstone AP group, NLR and PLR demonstrated a predictive value significantly superior to C-reactive protein (CRP), whereas NLR, PLR, and CRP were not significant predictors for alcoholic AP. CONCLUSION: Our study demonstrated that NLR and PLR can predict the severity of AP, but only in gallstone AP.

Predictive value of apolipoprotein B and A-I ratio in severe acute pancreatitis.

BACKGROUND AND AIM: Severe acute pancreatitis (SAP) has considerable mortality and morbidity rates. Although many indices have been developed to classify the severity of acute pancreatitis (AP), an optimal method for predicting SAP has not been identified. The ratio of apolipoprotein B to A-I (apoB/A-I) is associated with metabolic syndrome and inflammatory status. This study investigated the association between severity of AP and serum apoB/A-I ratio. METHODS: Patients with AP were prospectively enrolled at Yonsei University Wonju College of Medicine from March 2015 to August 2016. The severity of AP was assessed according to the revised Atlanta classification criteria (Atlanta 2012). RESULTS: Of 191 patients with AP, 134 (70.2%) had mild AP, 42 (22%) had moderately severe AP, and 15 (7.9%) had SAP; apoB/A-I ratio was highest in patients with SAP (P = 0.001). The apoB/A-I ratio was positively correlated with Atlanta classification, computed tomography severity index, and Bedside index for severity of AP. The apoB/A-I ratio showed the highest predictive value for SAP in patients with AP compared with apolipoprotein B or apolipoprotein A-I alone. CONCLUSION: Serum apoB/A-I ratio appears to have value for predicting SAP in patients with AP.

Clinicopathological characteristics of biliary neuroendocrine neoplasms: a multicenter study.

OBJECTIVES: This study assessed the clinicopathological features, therapeutic approaches, and prognosis of patients with biliary neuroendocrine neoplasm (NENs). MATERIALS AND METHODS: Multicenter retrospective study of patients with biliary tract NENs in the gallbladder, the extrahepatic bile duct, or the ampulla of Vater between 2005 and 2014. RESULTS: Total of 43 patients were included in the study. The median age was 62 years (range: 29-84 years) and 58.1% of the patients were male. The tumors occurred in the gallbladder (n = 11), the extrahepatic bile duct (n = 5) or the ampulla of Vater (n = 27). The liver was the most common metastatic site. Based on the 2010 World Health Organization classification, more patients with gallbladder NENs (11/11 (100%)) had neuroendocrine carcinoma G3 than those with NENs in the ampulla of Vater (10/27 (37.1%)). The median progression free survival time (39.3 vs 5.1 months, p = 0.001) and median overall survival time (46.9 vs 7.9 months, p < 0.001) were significantly longer in patients with ampulla of Vater NENs than gallbladder NENs. A 2010 World Health Organization classification of neuroendocrine carcinoma G3 was independently related to poor overall survival (hazard ratio (HR), 27.1; 95% confidence intervals (CI), 2.81-260.68; p = 0.004). CONCLUSION: The 2010 World Health Organization classification of neuroendocrine carcinoma G3 was the only factor related to poor prognosis in patients with biliary neuroendocrine neoplasms.

Relative Adrenal Insufficiency in Patients with Cirrhosis: A Systematic Review and Meta-Analysis.

BACKGROUND: Relative adrenal insufficiency (RAI) is frequently observed in patients with cirrhosis. We sought to identify evidence in the literature regarding the impact of RAI on clinical outcomes in cirrhotic patients. METHODS: We conducted a systematic review (SR) and meta-analysis (MA) using the Ovid-MEDLINE, EMBASE, and Cochrane Library databases to identify relevant studies in the literature. RESULTS: Of the 182 studies identified, 16 were eligible according to our inclusion criteria. The prevalence of RAI was 49.4% (744/1507), and cirrhotic patients with acute critical illnesses such as sepsis were more likely to have RAI compared to those without critical illnesses (P < 0.001). With respect to clinical outcomes, patients with RAI had poorer survival rates and an increased risk of complications such as bleeding and hepatorenal syndrome compared to those without RAI. Corticosteroid therapy had a beneficial effect on critically ill cirrhotic patients in terms of hospital survival rate. CONCLUSIONS: Based on this SR and MA, critically ill patients with cirrhosis have a high risk of RAI, and the presence of RAI is related to a poor prognosis and occurrence of cirrhotic complications.

Comparison of cytologic preparation methods in endoscopic ultrasound-guided fine needle aspiration for diagnosis of pancreatic adenocarcinoma.

BACKGROUND: There are few studies about the diagnostic yield of cytologic preparation method of pancreatic samples obtained by Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). The aim of this study was to compare the accuracy of ThinPrep(®) and smear method in diagnosis of pancreatic cancer. METHODS: A total of 125 EUS-FNA procedures were performed between July 2010 and June 2015. Patients in group I (n = 36; July 2010 to June 2014) had cytology slides prepared by consecutive allocation of samples. Patients in group II (n = 12; July 2014 to June 2015) had cytology slides prepared by alternately allocation of samples. RESULTS: There were 24 men and 24 women (median age: 67 years; range 39-84). The median size of lesions was 3.9 cm (range; 1.4-7.2 cm). The locations of the pancreatic cancer were 10 in head (20.8%), 21 in body (43.8%), and 17 in tail (35.4%). The ThinPrep(®) method confirmed malignancy in 35 of 48 cases (72.9%). On the other hand, the smear method confirmed malignancy in 44 of 48 cases (91.7%). The diagnostic yield of smear method was statistically higher than liquid method (P = 0.012). Also, smear method is superior to liquid method in both consecutive and alternative allocation method. ThinPrep(®) provided a correct diagnosis in one case where the smear method was incorrect. CONCLUSIONS: Smear method was a superior preparation method to liquid method in diagnosis of pancreatic cancer, even if splitting method was not used and variable allocation method was used.