Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial.

BACKGROUND: Owing to its strong acid inhibition, potassium-competitive acid blocker (P-CAB) based regimens for Helicobacter pylori (H. pylori) eradication are expected to offer clinical advantages over proton pump inhibitor (PPI) based regimens. This study aims to compare the efficacy and adverse effects of a 7-day and a 14-day P-CAB-based bismuth-containing quadruple regimen (PC-BMT) with those of a 14-day PPI-based bismuth-containing quadruple regimen (P-BMT) in patients with high clarithromycin resistance. METHODS: This randomized multicenter controlled clinical trial will be performed at five teaching hospitals in Korea. Patients with H. pylori infection who are naive to treatment will be randomized into one of three regimens: 7-day or 14-day PC-BMT (tegoprazan 50 mg BID, bismuth subcitrate 300 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or 14-day P-BMT. The eradication rate, treatment-related adverse events, and drug compliance will be evaluated and compared among the three groups. Antibiotic resistance testing by culture will be conducted during the trial, and these data will be used to interpret the results. A total of 366 patients will be randomized to receive 7-day PC-BMT (n = 122), 14-day PC-BMT (n = 122), or 14-day P-BMT (n = 122). The H. pylori eradication rates in the PC-BMT and P-BMT groups will be compared using intention-to-treat and per-protocol analyses. DISCUSSION: This study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration. TRIAL REGISTRATION: Korean Clinical Research Information Service registry, KCT0007444. Registered on 28 June 2022, https://cris.nih.go.kr/cris/index/index.do .

Underwater Versus Conventional Endoscopic Mucosal Resection for Superficial Non-ampullary Duodenal Epithelial Tumors: A Systematic Review and Meta-Analysis.

BACKGROUND/AIMS: Duodenal underwater endoscopic mucosal resection (UEMR) has been suggested as a feasible treatment option for superficial non-ampullary duodenal epithelial tumors (SNADETs). However, its efficacy and safety have not been fully established yet. Thus, the objective of this systematic review and meta-analysis was to determine the efficacy and safety of UEMR as compared with conventional endoscopic mucosal resection (CEMR) in the treatment of SNADETs. METHODS: We conducted a comprehensive literature search in PubMed, EMBASE, the Cochrane Library. Studies comparing CEMR and UEMR for the resection of SNADET were included. Outcomes included en-bloc and complete resection rates, adverse events, and procedure time. RESULTS: A total of six studies with 2454 lesions were included in the quantitative synthesis. En-bloc and complete resection rates were not significantly different between UEMR and CEMR (OR for en-bloc resection: 0.997 [95% CI 0.439-2.266]; OR for complete resection: 0.960 [95% CI 0.628-1.468]). There was no significant risk difference for perforation (risk difference: - 0.002; 95% CI - 0.009 to 0.005) or delayed bleeding (risk difference: - 0.001; 95% CI - 0.014 to 0.011). Procedure time was significantly shorter in the UEMR (standardized mean difference: - 1.294; 95% CI - 2.461 to - 0.127). The risk of recurrence was not significantly different between UEMR and CEMR (risk difference: 0.001; 95% CI - 0.041 to 0.044). CONCLUSION: Although our results did not show any superiority of UEMR over CEMR in the treatment of SNADETs, UEMR showed equivalent efficacy and safety as compared with CEMR and was associated with a shorter procedure time.

Long-term prognosis of curative endoscopic submucosal dissection for early colorectal cancer according to submucosal invasion: a multicenter cohort study.

BACKGROUND: Endoscopic submucosal dissection (ESD) can provide a high en bloc resection rate and has been widely applied as curative treatment for early colorectal cancer (ECC). However, surgical treatment is occasionally required, and reports on the long-term prognosis of ESD are insufficient. This study aimed to investigate the long-term outcomes of ECC removal by ESD, including local recurrence and metastasis. METHODS: This multicenter study was conducted retrospectively on 450 consecutive patients with ECC who were treated with ESD between November 2003 and December 2013. Clinical, pathological, and endoscopic data were collected to determine tumor depth, resection margin, lymphovascular invasion, and recurrence. RESULTS: The median follow-up period was 53.8 (12-138 months). The en bloc resection rate was 85.3% (384) and in intramucosal cancer being 84.1% and in superficial submucosal invasion (SM1) cancer being 89.8% (p = 0.158). The curative resection rate was 76.0% (n = 342), and there was no statistical difference between the two groups (77.3% vs. 71.4%, p = 0.231). The overall recurrence free survival rate (RFS) was 98.7% (444/450). In patients with curative resection, there was no statistically significant difference in RFS according to invasion depth (intramucosal: 99.3% vs. SM1: 97.1%, p = 0.248). CONCLUSIONS: Patients with curatively resected ECC treated with ESD showed favorable long-term outcomes. Curatively resected SM1 cancer has a RFS similar to that of intramucosal cancer.

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.

Effect of Nonsteroidal Anti-inflammatory Agents on Small Intestinal Injuries as Evaluated by Capsule Endoscopy.

BACKGROUND: Currently, because the population is aging, use of medications has been increasing, including use of nonsteroidal anti-inflammatory drugs (NSAIDs) and antithrombotic agents. AIMS: This study aims to investigate whether NSAIDs can cause damage to the small bowel (SB) mucosa. METHODS: Endoscopic videos of subjects who had undergone capsule endoscopy (CE) were evaluated by three experts in order to identify SB injury. All medications taken within 2 weeks from the time of CE were investigated. Cases with a final diagnosis of intestinal tuberculosis, inflammatory bowel disease, Behcet's disease, Peutz-Jeghers syndrome, small bowel lymphoma, or Henoch-Schönlein purpura were excluded from the analysis. RESULTS: Among the 273 subjects, 125 (45.8%) had SB erosions or ulcers (erosion group) and the remaining 148 (54.2%) did not (no erosion group). SB erosions or ulcers were more common in females, patients aged > 60 years, and subjects taking NSAIDs (p = 0.048, 0.032, and < 0.001, respectively). No statistically significant differences were found between the two groups in the following variables: history of cancer and GI surgery, reasons for the test, comorbidities, and use of anticoagulants and antiplatelet agents. Multivariate analysis showed that use of NSAIDs [OR 4.191 (95% CI 1.858-9.458), p < 0.001] was an independent risk factor for SB erosions or ulcers. CONCLUSIONS: Use of NSAIDs is the only independent risk factor for SB injury identified in this study. Antithrombotic agents do not cause or exacerbate damage to the SB, according to our results. CLINICAL TRIAL REGISTRATION: KCT0004795.

The role of linked color imaging in endoscopic diagnosis of Helicobacter pylori associated gastritis.

OBJECTIVE: Linked color imaging (LCI), a novel image-enhanced endoscopy, can make it easy to recognize differences in mucosal color. It may be helpful for diagnosing H. pylori associated gastritis and H. pylori infection status. We investigated whether LCI could improve the diagnostic accuracy of H. pylori associated gastritis. MATERIALS AND METHODS: Upper endoscopy was performed for 100 patients using white light imaging (WLI) and LCI. During the exam, endoscopic video was recorded. It was then analyzed by four expert endoscopists. They reviewed these videos for endoscopic diagnosis of atrophic gastritis, metaplastic gastritis, nodular gastritis and H. pylori infection. Tissue biopsies with rapid urease test were done to confirm H. pylori infection status and intestinal metaplasia. RESULTS: Kappa values for the inter-observer variability among the four endoscopists were fair to moderate under WLI and fair to good under LCI. Sensitivity, specificity, positive predictive value and negative predictive value for diagnosing H. pylori infection using WLI were 32.4%, 93.3%, 85.2% and 53.6%, respectively, while those for LCI were 57.4%, 91.3%, 88.7% and 64.3%, respectively. Total diagnostic accuracies for diagnosing H. pylori infection using WLI/LCI were 70.8%/78.8%. The accuracy and sensitivity of LCI for diagnosing H. pylori infection were significantly higher than those of WLI (p < .001 for both). However, there were no significant differences in the accuracy, sensitivity or specificity for diagnosing metaplastic gastritis between LCI and WLI. CONCLUSIONS: LCI has better diagnostic accuracy for H. pylori infection status than WLI. Clinical trial registration number: KCT0003674.

The addition of metformin to systemic anticancer therapy in advanced or metastatic cancers: a meta-analysis of randomized controlled trials.

Preclinical studies have demonstrated that metformin has anticancer properties and act in additive or synergistic way when combined with anticancer agents. We conducted this meta-analysis of randomized clinical trials to evaluate the effect of metformin added to systemic anticancer therapy in patients with advanced or metastatic cancer. A computerized systematic electronic search was performed using PubMed, PMC, EMBASE, Cochrane Library, and Web of Science databases (up to June 2020). From nine randomized clinical trials, 821 patients were included in the pooled analyses of odds ratios (ORs) with 95% confidence intervals (CIs) for overall response rate (ORR) and hazard ratios (HRs) with 95% CIs for progression-free survival (PFS) and overall survival (OS). The concomitant use of metformin with systemic anticancer therapy did not increase tumor response (the pooled OR of ORR = 1.23, 95% CI: 0.89-1.71, p = 0.21), compared with anticancer therapy alone. In terms of survival, metformin added to anticancer agents failed to prolong PFS (HR = 0.95, 95% CI: 0.75-1.21, p = 0.68) and OS (HR = 0.97, 95% CI: 0.80-1.16, p = 0.71). In conclusion, this meta-analysis of randomized clinical trials indicates that the addition of metformin to systemic anticancer therapy has no clinical benefits in patients with advanced or metastatic cancer.

The Protective Effect of 5-Aminosalicylic Acid Against Non-Steroidal Anti-Inflammatory Drug-Induced Injury Through Free Radical Scavenging in Small Intestinal Epithelial Cells.

Background and objectives: Non-steroidal anti-inflammatory drugs (NSAIDs) have been among the major causes of small intestinal injury in clinical practice. As such, the current study investigated the protective effect of 5-aminosalicylic acid (5-ASA) against an NSAID-induced small intestinal injury. Materials and Methods: IEC-6 cells were treated with various concentrations of indomethacin with or without 5-ASA in a serum-free medium, after which an 3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Dromide (MTT) assay, a cell apoptosis assay, a caspase-3 activity assay, a reactive oxygen species (ROS) content and Superoxide dismutase 2 (SOD2) activity measurement, a Western blotting for occludin and zonula occludens-1 (ZO-1) and a wound healing assay were conducted. Results: 5-ASA ameliorated indomethacin-induced cell apoptosis and an increase in the intracellular ROS content while augmenting the indomethacin-induced suppression of SOD2 activity in IEC-6 cells. Moreover, 5-ASA reversed the indomethacin-induced attenuation of occludin and ZO-1 expression and promoted faster wound healing effects in IEC-6 cells following an indomethacin-induced injury. Conclusion: Our results suggested that 5-ASA protects small intestinal cells against an NSAID-induced small intestinal injury by scavenging free radicals. Therefore, 5-ASA could be a potential treatment for an NSAID-induced small intestinal injury.

A risk-scoring model for the prediction of delayed bleeding after colorectal endoscopic submucosal dissection.

BACKGROUND AND AIMS: Delayed bleeding is an important adverse event after colorectal endoscopic submucosal dissection (ESD). We aimed to investigate the incidence and risk factors of delayed bleeding after colorectal ESD and to develop a risk-scoring model for predicting delayed bleeding. METHODS: This retrospective study was performed at 5 centers. The derivation and validation cohorts comprised 1189 patients from 1 center and 415 patients from the other 4 centers. We investigated the incidence and risk factors of delayed bleeding. Then, we developed a risk-scoring model for predicting delayed bleeding by using the data of the derivation cohort. We validated the scoring system in the validation cohort. RESULTS: Delayed bleeding occurred in 34 patients (2.9%) in the derivation cohort. In multivariate analysis, the risk factors of delayed bleeding were tumor location in the rectosigmoid colon (odds ratio [OR], 6.49; 95% confidence interval [CI], 1.96-21.42; P = .002), large tumor (≥30 mm) (OR, 2.10; 95% CI, 1.01-4.40; P = .048), and use of antiplatelet agents except for aspirin alone (OR, 4.04; 95% CI, 1.44-11.30; P = .008). These 3 factors were incorporated into a risk-scoring model for prediction of delayed bleeding. As the score based on this system increased, the incidence of delayed bleeding increased in the validation cohort. CONCLUSION: The risk-scoring model incorporating tumor location, tumor size, and use of antiplatelet agents can quantitatively predict the risk of delayed bleeding after colorectal ESD.

Complications of percutaneous endoscopic and radiologic gastrostomy tube insertion: a KASID (Korean Association for the Study of Intestinal Diseases) study.

BACKGROUND: Gastrostomy tube insertion is beneficial to selected patients, and percutaneous endoscopic gastrostomy (PEG) and percutaneous radiological gastrostomy (PRG) are two of the frequently used methods in gastrostomy. This study aimed to investigate the indications and complications of both PEG and PRG. METHODS: This was a retrospective multicenter cohort study. Patients who underwent initial PEG or PRG tube insertion for nutritional purpose between January 2010 and December 2015 at five university hospitals were included in the study. We analyzed the indications and all complications related to gastrostomy, which were divided into the major (systemic or life-threatening) and minor (local and non-life-threatening) categories. RESULTS: A total of 418 patients who underwent PEG (n = 324) and PRG (n = 94) were reviewed. The indications for gastrostomy tube insertion were different and included mainly neurological disease (n = 240, 74.1%) such as cerebrovascular accident in the PEG group (n = 119, 36.7%) and mainly surgical disease (n = 28, 29.8%) such as head and neck cancer (n = 16, 17.0%) in the PRG group (p = 0.05). There were no differences in the minor (16.4% vs. 19.1%, p = 0.52) and major (12.3% vs. 14.9%, p = 0.51) complication rates between the PEG and PRG groups. The risk factors for complications were age [yearly increments; odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01-1.06], tube diameter (1-Fr increments; OR 1.26, 95% CI 1.01-1.58), insertion time (1-min increments; OR 1.07, 95% CI 1.01-1.13), and neurological disease as the gastrostomy indication (vs. surgical disease; OR 4.61 95% CI 1.47-14.42). CONCLUSIONS: In our study, both PEG and PRG provided a safe route for nutrition delivery despite their different indications. Our data suggest that PEG might be the procedure of choice for patients with medical or neurological disease and PRG for patients with surgical disease in whom PEG is technically difficult or contraindicated.

Outcomes and Management Strategies for Capsule Retention: A Korean Capsule Endoscopy Nationwide Database Registry Study.

BACKGROUND: The most concerning complication of capsule endoscopy (CE) is capsule retention (CR) in the gastrointestinal (GI) tract; however, the clinical outcomes and management of patients with CR are still uncertain. AIMS: This study aimed to investigate the clinical outcomes and management of CR. METHODS: The outcomes of CR in multiple centers between October 2002 and June 2018 were retrospectively reviewed. Data on CE indication, findings, and management details were analyzed. RESULTS: A total of 2705 consecutive small-bowel CE procedures were performed. CR was detected in 20 cases (0.7%). The most common site of CR was the small bowel (19 cases), followed by the esophagus (one case). In patients who underwent CE, CR was detected in nine (0.6%) of 1397 patients with obscure GI bleeding. Further, CR occurred in 11 (6.5%) of 169 patients with Crohn's disease based on the final diagnoses after CE. Capsule retrieval was safely performed surgically in nine cases and endoscopically in six cases. The retained capsules dislodged after steroid treatment in two cases, whereas three cases of CR resolved without any intervention. In multivariate analysis, the development of abdominal symptoms after CR was a significant predictive factor for requiring endoscopic or surgical interventions for capsule extraction. CONCLUSIONS: This large multicenter study shows that CR is a rare complication with favorable clinical outcomes. Three-fourths of the patients with CR were managed with endoscopic or surgical intervention, which was required particularly in patients with abdominal symptoms after CR.

Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study.

BACKGROUND: The optimal treatment regimen or the duration of treatment for an endoscopic submucosal dissection (ESD)-induced gastric ulcer has not been established. The aim of this study was to assess the efficacy of novel proton-pump inhibitor, ilaprazole, for the treatment of ESD-induced gastric ulcer. METHODS: This was a prospective, open-label, randomized multicenter study. Between June 2015 and March 2018, a total of 176 patients (178 lesions) who underwent ESD for a gastric neoplasm were randomly allocated to receive the oral proton-pump inhibitor ilaprazole 20 mg or rabeprazole 20 mg daily for 8 weeks. The primary outcome was the ulcer healing rate at 4 and 8 weeks. RESULTS: A total of 155 (157 lesions) and 154 patients (156 lesions) were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks, 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis) or stage of ulcer (scar stage, 25.6% vs. 17.7%, p = 0.25 at 4 weeks, 92.3% vs. 88.6%, p = 0.59 at 8 weeks in the mITT analysis) between the treatment groups. The quality of ulcer healing was not significantly different between the two groups. No independent predictive factor for higher-quality ulcer healing was found in the multivariate analysis. CONCLUSIONS: According to this trial, ilaprazole and rabeprazole showed no significant difference in the healing of artificial gastric ulcers. Most of the ulcers achieved complete healing within 4-8 weeks. TRIAL REGISTRATION: ClinicalTrial.gov NCT02638584.

Effect of aged garlic powder on physicochemical characteristics, texture profiles, and oxidative stability of ready-to-eat pork patties.

OBJECTIVE: The aim of this study was to investigate the effects of aged garlic powder (AGP) on physicochemical characteristics, texture profiles, and oxidative stability of ready-to-eat (RTE) pork patties. METHODS: There were five treatment groups: a control; 1% fresh garlic powder (T1); 0.5%, 1%, and 2% AGP (T2, T3, and T4). Pork patties with vacuum packaging were roasted at 71°C for core temperature, stored at 4°C for 14 d, and then reheated for 1 min using a microwave. RESULTS: The AGP groups showed a lower the level of lipid oxidation and higher thiol contents than the control and T1. The pH value of the control increased whereas that of aged garlic groups decreased after re-heating process. In addition, the redness significantly increased with increasing level of AGP whereas the redness of the control and T1 decreased after re-heating process. T4 added patties improved textural and sensory properties compared to the control. CONCLUSION: The results of this study suggest that AGP addition to RTE pork patties can improve their sensory characteristics and oxidative stability.

Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, noninferiority trial.

BACKGROUND AND AIMS: Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in ERCP. The objective of this study was to compare efficacy and safety profiles of etomidate and propofol for endoscopic sedation. METHODS: This single-center, randomized, double-blind, noninferiority trial included patients with American Society of Anesthesiologists (ASA) physical status I to II who had been scheduled for ERCP. All patients received .05 mg/kg midazolam intravenously as pretreatment before receiving etomidate or propofol. Either etomidate or propofol was then administered according to group allocation. The primary endpoint was an overall respiratory event. A noninferiority margin of 10% was assumed. RESULTS: Sixty-three and 64 patients were enrolled in the etomidate and propofol groups, respectively. Respiratory events were identified in 10 patients (15.6%) in the etomidate group and 16 patients (25.4%) on the propofol group, with a rate difference of -9.8% (1-sided 97.5% confidence interval, -∞ to 4.2%). The overall incidence of cardiovascular events tended to be higher in the etomidate group (67.2% vs 50.8%, P = .060). In particular, tachycardia (heart rate > 100 beats/min) was more common in the etomidate group than in the propofol group (64.1% vs 34.9%, P = .001). Transient hypotension tended to be less common in the etomidate group (6.3 vs 15.9%, P = .084). CONCLUSIONS: Etomidate-based sedation during ERCP was noninferior to propofol-based sedation in terms of the overall incidence of respiratory events in patients with ASA physical status I to II. (International Clinical Trials Registry Platform number: KCT0001926.).

Safety and efficacy of early feeding based on clinical assessment at 4 hours after ERCP: a prospective randomized controlled trial.

BACKGROUND AND AIMS: The optimal timing of refeeding after ERCP is unknown. Some practices keep the patient fasting for 24 hours after ERCP, whereas others resume feeding earlier. We aimed to evaluate the risk of post-ERCP pancreatitis (PEP) in patients who initiate early feeding, based on their clinical assessment, including serum amylase testing performed at 4 hours after ERCP. METHODS: Patients who were scheduled for ERCP were recruited. Patients without abdominal pain and tenderness and a serum amylase level within 1.5-fold the upper limit of normal at 4 hours after ERCP were randomly assigned to either the 4-hour fasting or 24-hour fasting group. Patients from the 4-hour fasting group started oral intake 4 hours after ERCP, whereas those from the 24-hour fasting group fasted for 24 hours after ERCP. RESULTS: Among the 276 enrolled, PEP was identified in 3 (2.2%) from the 4-hour fasting group and in 5 (3.6%) from the 24-hour fasting group, with a rate difference of -1.4% (1-sided 97.5% confidence interval, -∞ to 2.5%). Four-hour fasting was non-inferior to 24-hour fasting in terms of PEP incidence. The total medical costs for treatment-related ERCP were significantly lower in the 4-hour fasting group than in the 24-hour fasting group (1157.20 ± 311.90 vs 1311.20 ± 410.70 U.S. dollars; P = .032). CONCLUSION: Early feeding in patients without abdominal pain and tenderness and a serum amylase level <1.5-fold the upper limit of normal at 4 hours after ERCP does not increase the incidence of PEP after ERCP and decreases medical costs. (Clinical trial registration number: KCT0002354.).

Clinicopathologic Significance of VHL Gene Alteration in Clear-Cell Renal Cell Carcinoma: An Updated Meta-Analysis and Review.

The von Hippel-Lindau (VHL) gene is inactivated frequently in sporadic clear-cell renal cell carcinomas (ccRCCs) by genetic alteration (mutation, loss of heterozygosity, or promoter hypermethylation). However, the pathological or prognostic significance of VHL gene alteration has not been well defined. We conducted this meta-analysis to evaluate the association between VHL alteration and clinopathologic findings in ccRCCs. We performed a systematic computerized search of online databases, including PubMed, EMBASE, Web of Science, and Google Scholar (up to July 2018). From ten studies, 1,082 patients were included in the pooled analyses of odds ratios (ORs) with 95% confidence intervals (CIs) for pathological features (nuclear grade and disease stage) or hazard ratios (HRs) with 95% CIs for overall survival (OS). VHL alteration was not significantly associated with nuclear grade (OR = 0.79, 95% CI: 0.59⁻1.06, p = 0.12) or disease stage (OR = 1.07, 95% CI: 0.79⁻1.46, p = 0.65). There was also no significant correlation between VHL alteration and OS (HR = 0.75, 95% CI: 0.43⁻1.29, p = 0.30). When we pooled HRs for OS according to the VHL alteration types, the combined HRs were 0.72 (95% CI: 0.47⁻1.11, p = 0.14) for VHL mutations and 1.32 (95% CI: 0.70⁻2.47, p = 0.39) for methylation. In conclusion, this meta-analysis indicates that VHL gene alteration is not significantly associated with the pathological features and survival in patients with ccRCC.

Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial.

BACKGROUND AND AIMS: Although a growing body of evidence demonstrates that propofol-induced deep sedation can be effective and performed safely, cardiopulmonary adverse events have been observed frequently. Etomidate is a new emerging drug that provides hemodynamic and respiratory stability, even in high-risk patient groups. The objective of this study was to compare safety and efficacy profiles of etomidate and propofol for endoscopic sedation. METHODS: A total of 128 patients undergoing EUS were randomized to receive either etomidate or propofol blinded administered by a registered nurse. The primary outcome was the proportion of patients with any cardiopulmonary adverse events. RESULTS: Overall cardiopulmonary adverse events were identified in 22 patients (34.38%) of the etomidate group and 33 patients (51.56%) of the propofol group, without significant difference (P = .074). However, the incidence of oxygen desaturation (4/64 [6.25%] vs 20/64 [31.25%]; P =.001) and respiratory depression (5/64 [7.81%] vs 21/64 [32.81%]; P =.001) was significantly lower in the etomidate group than in the propofol group. The frequency of myoclonus was significantly higher in the etomidate group (22/64 [34.37%]) compared with the propofol group (8/64 [12.50%]) (P =.012). Repeated measure analysis of variance revealed significant effects of sedation group and time on systolic blood pressure (etomidate group greater than propofol group). Physician satisfaction was greater in the etomidate group than in the propofol group. CONCLUSIONS: Etomidate administration resulted in fewer respiratory depression events and had a better sedative efficacy than propofol; however, it was more frequently associated with myoclonus and increased blood pressure during endoscopic procedures. (Clinical trial registration number: KCT0001701.).

Clinical outcome after enteroscopy for small bowel angioectasia bleeding: A Korean Associateion for the Study of Intestinal Disease (KASID) multiceter study.

BACKGROUND AND AIMS: Angioectasias are the most common sources of bleeding in the small bowel. They can be treated using balloon-assisted enteroscopy (BAE). This study aimed to identify the rebleeding rate and associated factors after BAE in patients with small bowel angioectasia bleeding. METHODS: We retrospectively analyzed the records of patients with bleeding due to small bowel vascular lesion in a multicenter enteroscopy database including 1108 BAEs. Finally, in rebleeding analysis, we analyzed 66 patients with angioectasia on the basis of the Yano-Yamamoto classification. Patients who had undergone endotherapy (ET) were divided into ET (n = 45) and non-ET (n = 21) groups. Rebleeding was defined as evidence of bleeding at least 30 days after BAE. RESULTS: Fifty-three patients (80.4%) underwent only one-side enteroscopy. The most common ET was argon plasma coagulation (87.2%). During a mean follow-up duration of 24.5 months, ET and non-ET groups had rebleeding rates of 15.6% and 38.1% (P = 0.059), respectively. Median rebleeding time of ET and non-ET groups was 32.5 and 62 months, respectively. Liver cirrhosis (LC), low platelet count (< 105 /µL), and transfusions were the rebleeding-associated factors in the univariate analysis. In the multivariate analysis, the presence of LC (HR 4.064, 95% CI 1.098-15.045; P = 0.036) was the only independent rebleeding-associated risk factor. CONCLUSIONS: ET using BAE did not significantly affect the rebleeding rate in patients with small bowel angioectasia bleeding. An independent rebleeding risk factor was the presence of LC. Regardless of ET, careful long-term follow-up may be needed, especially in LC patients with small bowel angioectasia bleeding.

Prediction model and risk score for perforation in patients undergoing colorectal endoscopic submucosal dissection.

BACKGROUND AND AIMS: Perforation is the adverse event of greatest concern during colorectal endoscopic submucosal dissection (ESD). Accurate risk prediction of perforation may enable prevention strategies and selection of the most efficient therapeutic option. This study aimed to develop and validate a risk prediction model for ESD-induced perforation. METHODS: A multicenter cross-sectional study was performed on 2046 patients who underwent colorectal ESD at 9 Korean ESD Study Group-affiliated hospitals. The enrolled patients were randomly divided into either a derivation set or a validation set. In the derivation set, a prediction score was constructed to assess the risk of perforation using preoperative and procedural-related predictors selected via logistic regression. Discrimination and calibration of the prediction model was assessed using the validation set. RESULTS: An ESD-induced perforation occurred in 135 patients (6.6%). In the derivation set, multivariate logistic regression identified endoscopist experience (≥50 ESDs: odds ratio [OR] = 0.59; 95% confidence interval [CI], 0.35-1.00), tumor size (+1-cm increments: OR = 1.39; 95% CI, 1.19-1.62), colonic location (OR = 2.20; 95% CI, 1.24-3.89), and submucosal fibrosis (OR = 2.00; 95% CI, 1.04-3.87) as predictive factors (C-statistic = 0.678; 95% CI, 0.617-0.739). In the validation set, the model showed good discrimination (C-statistic = 0.675; 95% CI, 0.615-0.735) and calibration (P = .635). When a simplified weighted scoring system based on the OR was used, risk of perforation ranged from 4.1% (95% CI, 2.8%-5.9%) in the low-risk group (score ≤4) to 11.6% (95% CI, 8.5%-15.6%) in the high-risk group (score >4). CONCLUSIONS: This study developed and internally validated a score consisting of simple clinical factors to estimate the risk of colorectal ESD-induced perforation. This score can be used to identify patients at high risk before colorectal ESD.

Endoscopic and oncologic outcomes according to indication criteria of endoscopic resection for early gastric cancer: a systematic review and meta-analysis.

BACKGROUND: The criteria for endoscopic resection for early gastric cancer (EGC) have been expanded recently, and it has become acceptable to use techniques that are regarded as having equivalent technical and pathological outcomes to absolute indication (AI). However, the long-term oncological outcomes of expanded indication (EI) have yet to be clarified. This meta-analysis aimed to assess the long-term outcome of EI versus AI, to identify the endoscopic feasibility and safety according to the indication, and to provide the appropriate recommendations for each indication. METHODS: Electronic databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and KoreaMed were searched for articles published between January 2000 and October 2014. After screening, the reviewers extracted the information from 12 retrospective cohort studies. A total of 9635 EGC lesions, 4150 lesions in the EI group and 5485 lesions in the AI group, were included in this study. RESULTS: Meta-analyses showed that the local recurrence rate [risk ratio (RR) 1.34; 95% CI 0.67-2.70] was not significantly higher in the EI group compared with the AI group, although the metachronous recurrence rate was higher in the EI group than in the AI group (RR 1.60; 95% CI 1.22-2.10). The rates of en bloc resection [odds ratio (OR) 0.57; 95% CI 0.41-0.78), complete resection (OR 0.37; 95% CI 0.25-0.57), and curative resection (OR 0.34; 95% CI 0.20-0.58) were significantly inferior in the EI group than in the AI group, whereas overall bleeding risk (RR 1.47; 95% CI 1.19-1.82) and procedure-related perforation rate (OR 2.04; 95% CI 1.56-2.68) were significantly higher in the EI group than in the AI group. CONCLUSIONS: This meta-analysis suggests that the EI group showed acceptable long-term outcomes with local recurrence rate that was not significantly inferior, although the metachronous recurrence rate was higher compared with that in the AI group.