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Aim: To evaluate the effect of secondary cytoreductive surgery (SeCRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) in recurrent epithelial ovarian cancer patients. Methods: This retrospective study analyzed a prospective database. We collected information of 389 patients who were diagnosed with recurrent epithelial ovarian cancer. All patients underwent SeCRS with or without HIPEC. Overall survival and progression‐free survival (PFS) were used to evaluate the treatment effectiveness. Results: Of the 389 patients collected, 123 underwent primary or interval cytoreductive surgery at initial treatment and SeCRS at recurrence (Group A), 130 underwent primary or interval cytoreductive surgery at initial and SeCRS plus HIPEC at recurrence (Group B), and 136 underwent primary or interval cytoreductive surgery plus HIPEC at initial and SeCRS plus HIPEC at recurrence (Group C). The median overall survival for Groups A, B, and C were 49.1 months (95% confidence interval [CI]: 47.6–50.5), 56.0 months (95% CI: 54.2–57.7), and 64.4 months (95% CI: 63.1–65.6), respectively. The median PFS for Groups A, B, and C were 13.1 months (95% CI: 12.6–13.5), 15.0 months (95% CI: 14.2–15.7), and 16.8 months (95% CI: 16.1–17.4), respectively. There were no significant difference in incidence and grade of adverse events among groups. Conclusions: This study suggested that SeCRS plus HIPEC followed by chemotherapy resulted in longer overall survival and PFS than only SeCRS followed by chemotherapy in patients with recurrent ovarian cancer, especially in patients who were treated with repeat HIPEC. [ABSTRACT FROM AUTHOR]

Objective. To compare the effects of sevoflurane inhalation and intravenous anesthesia on hemodynamics, serum myocardial enzymes, and myocardial markers in elderly patients undergoing hysterectomy. Methods. Group A and group B were established randomly regarding a total of 126 elderly patients who underwent an elective hysterectomy. Patients in group A were given full anesthesia with sevoflurane, and patients in group B were given anesthesia with intravenous anesthesia. The operation time, anesthesia time, and recovery time in Postanesthesia Care Unit (PACU) were compared; plasma cortisol concentration, hemodynamics, serum myocardial enzymes, and myocardial markers were detected and compared between the two groups of patients before anesthesia ( T 0 ), after anesthesia ( T 1 ), and after surgery ( T 2 ). Results. Group A observed a longer extubation time and recovery time in PACU than group B (P < 0.05). Results show a lower systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and plasma cortisol concentration of T 1 by comparison with those of T 0 (P < 0.05), but no significant difference remains in terms of intergroup SBP, DBP, and HR (P > 0.05), and there was no interaction effect of groups and time (P > 0.05). The two groups showed no great disparity in the levels of lactate dehydrogenase (LDH), aspartate transaminase (AST), creatine kinase (CK), and CK-MB as a subtype of CK before surgery between the two groups of patients (P > 0.05). After surgery, LDH, AST, CK, and CK-MB levels in both groups were witnessed a surge, in which group A obtained higher levels of LDH, AST, CK, and CK-MB (all P < 0.05). Conclusion. Total intravenous anesthesia will not increase the hemodynamic fluctuation of elderly patients undergoing hysterectomy and can reduce the damage to the myocardium of patients with surgical trauma, which can protect the myocardium of elderly patients to a certain extent, so it can be adopted as the optimal anesthesia protocol for surgery. [ABSTRACT FROM AUTHOR]

Background: Pneumonia is the most frequently encountered postoperative pulmonary complications (PPC) after orthotopic liver transplantation (OLT), which cause high morbidity and mortality rates. We aimed to develop a model to predict postoperative pneumonia in OLT patients using machine learning (ML) methods.Methods: Data of 786 adult patients underwent OLT at the Third Affiliated Hospital of Sun Yat-sen University from January 2015 to September 2019 was retrospectively extracted from electronic medical records and randomly subdivided into a training set and a testing set. With the training set, six ML models including logistic regression (LR), support vector machine (SVM), random forest (RF), adaptive boosting (AdaBoost), extreme gradient boosting (XGBoost) and gradient boosting machine (GBM) were developed. These models were assessed by the area under curve (AUC) of receiver operating characteristic on the testing set. The related risk factors and outcomes of pneumonia were also probed based on the chosen model.Results: 591 OLT patients were eventually included and 253 (42.81%) were diagnosed with postoperative pneumonia, which was associated with increased postoperative hospitalization and mortality (P < 0.05). Among the six ML models, XGBoost model performed best. The AUC of XGBoost model on the testing set was 0.734 (sensitivity: 52.6%; specificity: 77.5%). Pneumonia was notably associated with 14 items features: INR, HCT, PLT, ALB, ALT, FIB, WBC, PT, serum Na+, TBIL, anesthesia time, preoperative length of stay, total fluid transfusion and operation time.Conclusion: Our study firstly demonstrated that the XGBoost model with 14 common variables might predict postoperative pneumonia in OLT patients. [ABSTRACT FROM AUTHOR]

Background: Despite the continued improvement in the surgical techniques during primary total knee arthroplasty (TKA), literatures indicate that up to 10 to 20% patients are not satisfied with their outcomes. Psychological factors in this dissatisfaction are yet to be clearly identified. The aim of this study is to develop a method to assess whether the patient's current mental state is suitable enough to accept a TKA surgery. Methods: Preoperative demographic and clinical data of 532 patients who underwent TKA were prospectively obtained from January 2012 until December 2016. We recorded the scores evaluated by SF-36 questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) preoperatively and 1 year postoperatively. Preoperative Life Satisfaction Rating (LSR) is emphatically evaluated. Results: Poor preoperative score of LSR was a significant predictor of dissatisfaction after TKA. Patients with low LSR reported significant pain and stiffness, although there was no remarkable effect on functionality of the replaced joint. The results also showed that age and BMI were not strong predictors of satisfaction in TKA. Conclusion: Our outcomes can help clinicians evaluate whether a patient's current mental status is favorable for TKA. If patients have extreme low scores of LSR (less than 10), a psychological intervention should be recommended for better satisfaction following a TKA surgery. This would also allow surgeons to individually assess the risks and benefits of surgery. [ABSTRACT FROM AUTHOR]

To explore the differences among grades of recanalization on outcomes of endovascular treatment for acute anterior large vessel occlusion with small infarct core beyond the 6-hour time window. Patients beyond the 6-hour time window with Alberta Stroke Program Early Computed Tomography Score >7 were retrospectively enrolled from the endovascular treatment for acute anterior circulation ischemic stroke (ACTUAL) registry. They were divided into 3 groups according to the degree of recanalization: modified treatment in cerebral infarction (mTICI) 0–2a, 2b, and 3. We compared the differences of outcomes among groups on modified Rankin Scale score at 90 days, symptomatic intracerebral hemorrhage within 72 hours, and mortality. A total of 101 patients were enrolled. Median time from onset to groin puncture was 415 minutes (interquartile range: 387–497 minutes). Favorable functional outcomes were significantly better in patients with successful recanalization than in patients with failed recanalization (mTICI 0–2a, 22.7% [5/22]; mTICI 2b, 48.0% [12/25]; and mTICI 3, 61.1% [33/54]; trend P = 0.01). Complete recanalization (mTICI 3) (odds ratio, 5.34; 95% confidence interval, 1.71–16.66; P = 0.004) was associated with good functional outcome. Mortality was different among groups at 90 days (mTICI 0–2a, 36.4% [8/22]; mTICI 2b, 0, [0/25]; P = 0.001; mTICI 0–2a, 36.4% [8/22]; mTICI 3, 9.3% [5/54]; P = 0.008; and mTICI 2b, 0, [0/25]; mTICI 3, 9.3% [5/54]; P = 0.173). There were no significant differences of symptomatic intracranial hemorrhage among groups (mTICI 0–2a, 22.7% [5/22]; mTICI 2b, 12.0% [3/25]; and mTICI 3, 9.3% [5/54]; P = 0.28). For acute anterior circulation stroke patients, who were beyond the 6-hour time window, yet with small ischemic core, complete recanalization following endovascular treatment may play the most important role on clinical outcome. [ABSTRACT FROM AUTHOR]

Background: Glioblastoma (GBM) is one of the worst cancers with bad prognosis despite systemic chemotherapy and radiotherapy after surgery.Methods: In this study, 71 patients with GBM were enrolled and randomly assigned to two groups: Receiving radiotherapy with concomitant and adjuvant temozolomide (TMZ) (TMZ, standard therapy) after surgery, or receiving radiotherapy with concomitant and adjuvant local delivery of nimustine (ACNU) rendezvousing with oral TMZ (rendezvous therapy). In the follow-up of all patients and the progression-free survival (PFS), overall survival (OS), Karnofsky performance score (KPS) and toxicities were recorded.Results: For the whole cohort, the median OS was 18.0 months, and the median PFS was 7.8 months. A significantly longer OS was observed in patients received rendezvous therapy than those who receiving standard therapy (18.5 months vs. 16.0 months; P = 0.014), as well as PFS (8.8 months vs. 7.0 months; P = 0.008). The KPS ≥70 rates were 81.8%, 40.9%, 20.5% in 1, 2, and 3 years for the rendezvous therapy group, significantly superior to standard therapy group. The most common toxicities were tolerable gastrointestinal reaction, liver dysfunction, and hematological toxicities, which were relieved with symptomatic treatment. Grade 3 or 4 toxicity was documented in 8 (18.3%) patients in rendezvous therapy group, while it was observed in 6 (22.2%) patients in standard therapy group during whole treatment process.Conclusions: Compared to standard therapy, the antitumor effects of rendezvous therapy were more effective in GBM patients without increasing the toxicities. [ABSTRACT FROM AUTHOR]

Background and Aims: The therapeutic outcome of endoscopic submucosal dissection (ESD) for large protruding tumors has not yet been evaluated. We aimed to compare the outcomes of ESD in protruding tumors with those of laterally spreading tumors (LSTs).Methods: Endoscopic submucosal dissection was attempted in 218 patients with 220 colorectal tumors ≥30 mm in diameter (67, protruding tumors; 153, LSTs) from July 2007 to June 2014. We retrospectively reviewed patient medical records, therapeutic outcomes, and procedure-related adverse events. This study defined lesions with a height of 10 mm or more as protruding tumors and those with a height under 10 mm as LSTs.Results: The mean lesion diameter, height, and volume were 43.8, 9.5 mm, and 13.6 cm(3), respectively. The mean procedure time was 75.5 min. Deep submucosal cancer was more frequent in protruding tumors than in LSTs (11.9 vs. 2.6%, P = 0.005). Severe fibrosis was more common in protruding tumors than in LSTs (19.4 vs. 3.9%, P < 0.001). En bloc resection and complete resection rates were lower in protruding tumors than in LSTs (en bloc resection, 76.1 vs. 92.8%, P = 0.001; complete resection, 64.2 vs. 79.1%, P = 0.020). Intra- and post-procedural bleeding were more frequent in protruding tumors than in LSTs (22.4 vs. 2.6%, P < 0.001; 6.0 vs. 0.7%, P = 0.031, respectively). By multivariate analysis, protruding tumor morphology (odds ratio 1.919, P = 0.048) and tumor size ≥60 mm (odds ratio 2.490, P = 0.030) were associated with incomplete resection.Conclusions: Endoscopic submucosal dissection for protruding tumors is less effective than ESD for LSTs, with lower rate of complete resection occurring with protruding tumors. [ABSTRACT FROM AUTHOR]

Background: Experience in gastric endoscopic submucosal dissection (ESD) has been suggested as a prerequisite for performing colorectal ESD by some experts.Aims: To evaluate the feasibility of performing colorectal ESD without experience in gastric ESD.Methods: Between November 2009 and December 2013, ESD was attempted for 250 colorectal lesions by an endoscopist having extensive colonoscopy experience but no prior experience of gastric ESD. All attempts were categorized according to the chronological order of procedures: group 1, attempts 1-50; group 2, attempts 51-100; group 3, attempts 101-150; group 4, attempts 151-200; and group 5, attempts 201-250. Procedure-related outcomes were analyzed.Results: En bloc resection rate ≥80% was achieved after initial ten ESD attempts. The ESD success rate (72, 80, 90, 90, and 94% in group 1-5, respectively; p for trend = 0.001), perforation rate (14, 14, 6, 6, and 0% in group 1-5, respectively; p for trend = 0.003), and macroperforation rate (6, 6, 2, 2, and 0% in group 1-5, respectively; p for trend = 0.042) improved as experience accumulated. Performing >100 ESDs, rectal location, and absence of submucosal fibrosis were independent predictors of successful procedure.Conclusion: Colorectal ESD can be safely and effectively performed by an endoscopist having extensive experience in colonoscopy-related procedures even without previous experience of gastric ESD. Meticulous case selection for ESD novice and active supervision by expert endoscopists during the initial learning period may minimize the risk of perforation. [ABSTRACT FROM AUTHOR]

Background: An anastomotic stricture after colorectal surgery is principally managed by endoscopic balloon dilation (EBD). Although this intervention is effective, however, subsequent procedures or surgical interventions are often required. This study aimed to assess the long-term outcomes of EBD for anastomotic stricture arising from colorectal cancer surgery. Materials and methods: We analyzed 173 patients who received curative surgery for colorectal cancer at our hospital between January 2000 and December 2022 and had undergone EBD to manage anastomotic stricture. The medical records of these cases were retrospectively reviewed to assess the outcomes and risk factors for restenosis and permanent stoma. Results: Of the 173 study patients, 41 (23.7%) presented with restenosis with a median time to recurrence of 49 [37–150] days. The restenosis group was significantly younger (55.6 years versus 60.8 years), with a more prominent rectal location (80.5% versus 57.6%), a higher incidence of hand-sewn anastomosis (24.4% versus 5.3%), and a higher percentage of neoadjuvant radiotherapy (34.1% versus 5.3%, P < 0.001). Multivariable analysis indicated neoadjuvant radiotherapy (adjusted HR 2.48; 95% CI 1.03–5.95) and cerebral vascular disease (adjusted HR 6.97; 95% CI 2.15–22.54) as independent prognostic factors for restenosis. Fourteen patients (8.1%) required a permanent stoma due to treatment failure. All cases needing a permanent stoma were male (14 patients, 100%, P = 0.007) and this group had a higher rate of neoadjuvant radiotherapy, adjuvant chemotherapy, and hand-sewn anastomosis. Conclusion: Patients receiving neoadjuvant radiotherapy are most prone to restenosis after an EBD intervention to manage an anastomotic stricture. Neoadjuvant radiotherapy is also a strong risk factor for requiring a permanent stomas due to treatment failure. [ABSTRACT FROM AUTHOR]

Background: Owing to an increased number of colonoscopy screenings, the incidence of diagnosed rectal neuroendocrine tumors (NETs) has also increased. Tumor size is one of the most frequently regarded factors when selecting treatment; however, it may not be the determinant prognostic variable. We aimed to evaluate oncological outcomes according to the treatment modality based on the size of rectal NETs. Methods: A retrospective analysis was performed on patients who were treated for rectal NETs between March 2000 and January 2016 at the Asan Medical Center, Seoul, Korea. Patients who underwent endoscopic removal, local surgical excision, and radical resection were included. The primary outcome was recurrence-free survival (RFS). Data were specified and analyzed following the 2019 World Health Organization classification (WHO). Results: A total of 644 patients were categorized under three groups according to the treatment modality used: endoscopic removal (n = 567), surgical local excision (n = 56), and radical resection (n = 21). Of a total of 35 recurrences, 27 were local, whereas eight were distant. The RFS rate did not differ significantly between the treatment groups in the same tumor-size group (≤ 1 cm group: P =.636, 1–2 cm group: P =.160). For T1 tumors, RFS rate was not different between local excision and radical resection (≤ 1 cm group: P =.452, 1–2 cm group: P =.700). Depth of invasion, a high Ki-67 index, and margin involvement were confirmed as independent risk factors for recurrence. Among patients treated with endoscopic removal, endoscopic biopsy was a significant factor for worse RFS (P <.001), while tumor size did not affect the RFS. Conclusion: The current guideline recommends treatment options according to tumor size. However, more oncologically important prognostic factors include muscularis propria invasion and a higher Ki-67 index. [ABSTRACT FROM AUTHOR]

Background and Aim: This study aimed to investigate the effect of stenting‐related factors, including endoscopists' expertise, on clinical outcomes after bridge‐to‐surgery (BTS) stenting for obstructive colorectal cancer (CRC). Methods: We analyzed BTS stenting‐related factors, including stenting expertise and the interval between stenting and surgery, in 233 patients (63 [13] years, 137 male) who underwent BTS stenting for obstructive CRC. We evaluated the influence of these factors on post‐BTS stenting clinical outcomes such as stent‐related complications and cancer recurrence. Results: The interval between stenting and surgery was ≤ 7 days in 79 patients (33.9%) and > 7 days in 154 patients (66.1%). BTS stenting was performed by endoscopists with ≤ 50, 51–100, and > 100 prior stenting experiences in 94, 43, and, 96 patients, respectively. The clinical success rate of BTS stenting was 93.1%. Stent‐related and postoperative complications developed in 19 (8.2%) and 20 (8.6%) patients, respectively. Cancer recurrence occurred in 76 patients (32.6%). Short BTS interval of ≤ 7 days increased the risk of postoperative complications (odds ratio [OR], 2.61 [1.03–6.75]; P = 0.043). Endoscopists' stenting experience > 100 showed greater clinical success of stenting (OR, 5.50 [1.45–28.39]; P = 0.021) and fewer stent‐related complications (OR, 0.26 [0.07–0.80]; P = 0.028) compared with stenting experience ≤ 50. BTS stenting‐related factors did not affect long‐term oncological outcomes. Conclusion: Greater expertise of endoscopists was associated with better short‐term outcomes, including high stenting success rate and low rate of stent‐related complications after BTS stenting for obstructive CRC. An interval of > 7 days between BTS stenting and surgery was required to decrease postoperative complications. [ABSTRACT FROM AUTHOR]

The clinical usefulness of repeat colonoscopic polypectomy in patients with numerous polyps has not been sufficiently determined. We aimed to analyze the clinical outcomes of colonoscopic polypectomy with surveillance colonoscopies in patients with ≥ 10 polyps. We reviewed the medical records of 152 patients who underwent polypectomy of ≥ 10 polyps at the baseline colonoscopy. We investigated polyp number, polyp size, polypectomy method, procedure time, and adverse events of the baseline colonoscopy. We also investigated the frequency and interval of surveillance colonoscopies and their findings. The mean number of polyps detected at the baseline colonoscopy was 20.0, of which 16.0 polyps were endoscopically resected. The mean size of the largest polyp was 13.4 mm. The mean procedure time was 54.9 min. Post-polypectomy bleeding occurred in 6 (3.9%) patients, all of whom were treated conservatively. No patients developed perforation. With an increasing number of surveillance colonoscopies, the number of detected polyps and the procedure time decreased. Surveillance colonoscopies identified colorectal cancer only in three patients (2.0%), all of which were mucosal cancers that could be curatively treated by polypectomy. Colonoscopic polypectomy with repeat surveillance colonoscopies is a clinically effective, efficient, and safe management option in patients with ≥ 10 polyps. [ABSTRACT FROM AUTHOR]

Background: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear.Methods: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement.Results: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function.Conclusions: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research.Registration: URL: https://www.Clinicaltrials: gov. Unique identifier: NCT03284827. [ABSTRACT FROM AUTHOR]

Background: There is an ongoing debate on the off-hour effect on endovascular treatment (EVT) for acute large vessel occlusion (LVO). Aim: This meta-analysis aimed to compare time metrics and clinical outcomes of acute LVO patients who presented/were treated during off-hour with those during working hours. Summary of review: Structured searches on the PubMed, Embase, Web of Science, and Cochrane Library databases were conducted through 23 February 2021. The primary outcomes were onset to door (OTD), door to imaging, door to puncture (DTP), puncture to recanalization, procedural time, successful recanalization, symptomatic intracranial hemorrhage (SICH), mortality in hospital, good prognosis (90-day modified Rankin Scale (mRS) score 0–2), and 90-day mortality. The secondary outcomes were imaging to puncture (ITP), onset to puncture (OTP), onset to recanalization (OTR), door to recanalization (DTR) time, mRS 0–2 at discharge, and consecutive 90-day mRS score. The odds ratio (OR) and weighted mean difference (WMD) with 95% confidence interval (CI) of the outcomes were calculated using random-effect models. Heterogenicity and publication bias were analyzed. Subgroup and sensitivity analyses were conducted as appropriate. Nineteen studies published between 2014 and 2021 with a total of 14,185 patients were eligible for quantitative synthesis. Patients in the off-hour group were significantly younger than those in the on-hour group and with comparable stroke severity and intravenous thrombolysis rate. The off-hour group had longer OTD (WMD [95% CI], 12.83 [1.84–23.82] min), DTP (WMD [95% CI], 11.45 [5.93–16.97] min), ITP (WMD [95% CI], 10.39 [4.61–16.17] min), OTP (WMD [95% CI], 25.30 [13.11–37.50] min), OTR (WMD [95% CI], 25.16 [10.28–40.04] min), and DTR (WMD [95% CI], 18.02 [10.01–26.03] min) time. Significantly lower successful recanalization rate (OR [95% CI], 0.85 [0.76–0.95]; p = 0.004; I 2 = 0%) was detected in the off-hour group. No significant difference was noted regarding SICH and prognosis. But a trend toward lower OR of good prognosis was witnessed in the off-hour group (OR [95% CI], 0.92 [0.84–1.01]; p = 0.084; I 2 = 0%). Conclusions: Patients who presented/were treated during off-hour were associated with excessive delays before the initiation of EVT, lower successful reperfusion rate, and a trend toward worse prognosis when compared with working hours. Optimizing the workflows of EVT during off-hour is needed. [ABSTRACT FROM AUTHOR]

Background: Preclinical studies in transgenic models of Alzheimer's disease (AD) suggest that DHP1401 has neuroprotective and memory-enhancing effects.Objective: To evaluate the efficacy and safety of DHP1401 in AD patients treated with donepezilMethods:Methods: In a double-blind study, patients with mild-to-moderate AD were randomized (1:1:1) to receive a twice daily total dose of 500 mg or 1000 mg DHP1401 or placebo for 24 weeks. Tolerability and safety were monitored at baseline and weeks 12 and 24.Results: total of 180 patients were randomized to Active 1 (500 mg: n = 62), Active 2 (1000 mg: n = 53), and control groups (n = 65) in 16 sites in Korea. There was no significant difference in the Alzheimer's Disease Assessment Scale (ADAS-cog) score, the primary efficacy endpoint, from baseline. However, in the subgroup with mild AD patients (MMSE, 20-26) who received the high dose of DHP1401 and the group that received donepezil 5 mg, the ADAS-cog scores improved. MMSE and K-TMT-e type B were significant in both active groups at week 24. The most frequently observed symptom was dizziness (2.78%), and the most commonly observed reactions were related to metabolism and nutrition disorders (5.00%). No remarkable adverse events were observed for 24 weeks.Conclusion: Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials. [ABSTRACT FROM AUTHOR]

Background: Although upper gastrointestinal (GI) neoplasms are not rare in patients with familial adenomatous polyposis (FAP), few studies have focused on them and the long-term outcomes of their treatment by endoscopy. Therefore, we aimed to investigate the prevalence and endoscopic treatment outcomes of upper GI neoplasms in patients with FAP. Methods: Among 215 patients diagnosed with FAP between January 1991 and December 2019, 208 who underwent esophagogastroduodenoscopy were eligible. The clinical features and endoscopic treatment outcomes of upper GI neoplasms were retrospectively investigated and analyzed. Results: Among the enrolled patients, 113 (54.3%) had one or more upper GI neoplasms: gastric adenoma (n = 34), gastric cancer (n = 7), nonampullary duodenal adenoma (n = 86), and ampullary adenoma (n = 53). Among patients with gastric neoplasms (n = 37), 24 (64.9%) underwent treatment (endoscopic treatment: 22, surgery: 2). No tumor-related mortality occurred during median follow-up of 106 months (interquartile range [IQR] 63–174). Endoscopic treatment was performed in 47 (54.7%) of 86 patients with nonampullary duodenal adenoma and in 32 (60.4%) of 53 patients with ampullary adenoma. No patient underwent surgery for duodenal neoplasms, and no tumor-related mortality occurred during median follow-up of 88 months (IQR 42–145). The proportion of patients with increased Spigelman stage at 2 years after the initial diagnosis or treatment was significantly higher in untreated group than in the group treated for duodenal neoplasms (27.3% vs. 0.0%, p = 0.001). Conclusion: Endoscopic surveillance in FAP patients is important for the detection and treatment of upper GI neoplasms in early stage. In particular, endoscopic therapy for duodenal neoplasms can reduce the severity of duodenal polyposis. [ABSTRACT FROM AUTHOR]

Introduction: Immunomodulators remain fundamental for the medical treatment of Crohn's disease (CD). Methotrexate (MTX) is widely used as a second-line immunomodulator; however, there is a lack of recent data on MTX monotherapy among the Asian population with CD. Therefore, in this study, we aimed to investigate the tolerability and clinical outcomes of MTX in Korean patients with CD. Methods: A retrospective chart review was performed for CD patients treated with MTX monotherapy or in combination with 5-aminosalicylic acid (5-ASA), at the Asan Medical Center, Seoul, South Korea. The tolerability of MTX monotherapy within 6 months was assessed and the clinical effectiveness of MTX was evaluated based on the Crohn's disease activity index (CDAI). Results: In total, 85 patients were included, of which 29 (34.1%) discontinued MTX due to intolerability during the follow-up. Adverse events (AEs) were reported in 41 (48.2%) patients. The most common AE was gastrointestinal disorders (17/41) and only one patient experienced a serious AE, a systemic infection that required hospitalization. Among the 56 patients who tolerated MTX within 6 months, 44 (65.9%) showed a clinical response. Moreover, no factor was significantly associated with intolerability. The administration method was the only factor significantly associated with a response to MTX (p = 0.041). The adjusted odds ratio of parenteral injection compared to oral administration was 5.68 (95% confidence interval (CI), 1.07–30.08). Conclusion: In this study, one-third of patients were intolerant to MTX; nonetheless, the response rate was as high as 65.9% among tolerant patients. In addition, no significant factors affected intolerability. In terms of the clinical response, parenteral injection could be better than oral administration. [ABSTRACT FROM AUTHOR]

Small rectal neuroendocrine tumors (NETs) can be treated using cap-assisted endoscopic mucosal resection (EMR-C), which requires additional effort to apply a dedicated cap and snare. We aimed to evaluate the feasibility of a simpler modified endoscopic mucosal resection (EMR) technique, so-called anchored snare-tip EMR (ASEMR), for the treatment of small rectal NETs, comparing it with EMR-C. We retrospectively evaluated 45 ASEMR and 41 EMR-C procedures attempted on small suspected or established rectal NETs between July 2015 and May 2020. The mean (SD) lesion size was 5.4 (2.2) mm and 5.2 (1.7) mm in the ASEMR and EMR-C groups, respectively (p = 0.558). The en bloc resection rates of suspected or established rectal NETs were 95.6% (43/45) and 100%, respectively (p = 0.271). The rates of histologic complete resection of rectal NETs were 94.1% (32/34) and 88.2% (30/34), respectively (p = 0.673). The mean procedure time was significantly shorter in the ASEMR group than in the EMR-C group (3.12 [1.97] vs. 4.13 [1.59] min, p = 0.024). Delayed bleeding occurred in 6.7% (3/45) and 2.4% (1/41) of patients, respectively (p = 0.618). In conclusion, ASEMR was less time-consuming than EMR-C, and showed similar efficacy and safety profiles. ASEMR is a feasible treatment option for small rectal NETs. [ABSTRACT FROM AUTHOR]

Background and Aim: The clinical impact of perianal Crohn's disease (CD) (pCD), a well‐known poor prognostic factor of CD, has not been fully evaluated in Asian patients. We investigated the outcomes of CD in Korean patients according to the presence of pCD at CD diagnosis. Methods: Using 2010–2014 data from the national health insurance claims database, we evaluated the disease course of CD according to the presence of pCD at CD diagnosis. The results were verified in a hospital‐based cohort of 2923 patients. Results: The cumulative risk of intestinal resection was lower in patients with pCD at diagnosis than in those without, in the population‐based cohort (9.1% vs 14.7% at 5 years after diagnosis, P < 0.001), but it was similar between the two groups in the hospital‐based cohort (36.8% vs 36.8% at 10 years after diagnosis, P = 0.950). Moreover, the cumulative risk of behavioral progression was not significantly different between the two groups in the hospital‐based cohort (43.4% vs 41.6% at 10 years after diagnosis, P = 0.366). On multivariable analysis, pCD at CD diagnosis was not a predictor of intestinal resection, behavioral progression, CD‐related hospital admission, or diverting surgery; however, it was an independent predictor of proctectomy (hazard ratio [HR] 3.210, P < 0.001) and anorectal cancer (HR 3.104, P = 0.047). Conclusions: Although the presence of pCD increased the risk of proctectomy and anorectal cancer in Asian patients, the clinical impact of pCD on the overall outcomes of patients with CD may be less significant in Asian patients compared with Western patients. [ABSTRACT FROM AUTHOR]

Variations by hospital and region in the selection of an early invasive strategy (EIS) after non–ST-segment elevation myocardial infarction (NSTEMI) in patients with high-risk criteria are unknown. We evaluated the data of 7037 patients with NSTEMI from 20 hospitals of 3 regions from the Korean Acute Myocardial Infarction Registry–National Institute of Health database. We used hierarchical generalized linear mixed-models to estimate region- and hospital-level variation in the selection of an EIS after adjusting for patient-level high-risk criteria. We explored the variation using the median rate ratio (MRR), which estimates the relative difference in the risk ratios of two hypothetically identical patients at two different sites. An EIS was selected in 84.4% of patients. At the hospital level, the median selection rate was 80.4%. At the region level, the median selection rate was 74.9% in the east region, 81.3% in the north region, and 83.9% in the west region, respectively. After adjusting for patient-level covariates, we found significant hospital- (MRR 2.19, 95% confidence interval [CI]: 1.74–3.03) and region-level (MRR 1.88, 95%CI: 1.26–5.44) variation in the selection of an EIS. Among patient-level factors, male sex, ongoing chest pain, history of coronary artery disease or acute heart failure, and GRACE risk score > 140 were independently associated with the selection of an EIS. We observed significant hospital- and region-level variation in the selection of an EIS after NSTEMI in high-risk patients. Quality improvement efforts are required to standardize decision making and to improve clinical outcomes. • There is significant hospital- and region-level variation in early invasive strategy selection. • An early conservative strategy is often chosen when an early invasive strategy would provide more benefit. • Site-level variation reflects that there is significant undertreatment for high-risk patients that could worsen clinical outcome. • Quality improvement efforts are required to standardize decision making and improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: Some researchers have achieved favorable efficacy in the treatment of primary papillary thyroid microcarcinoma (PTMC) using microwave ablation (MWA). However, as PTMC is a slowly progressing disease, a long follow-up period is required to confirm treatment efficacy. Our study aim was to investigate the long-term efficacy and safety of ultrasound (US)-guided MWA in PTMC. Methods: In this study, 41 patients with thyroid masses (41 nodules) were diagnosed with PTMC by fine-needle aspiration or core needle biopsy. They underwent US-guided MWA. Preablation ultrasonic images of the thyroid nodules were collected, and the volumes were measured. The patients had follow-up at 1, 3, 6, and 12 months in the first year and every 6 months from the second year on, after MWA. The volume reduction rates (VRRs) of the thyroid nodules were analyzed. Results: In total, 40 of 41 nodules were completely ablated by MWA. After 60 months of follow-up, the volume significantly decreased from a median of 55.78 mm3 (quartile: 21.50, 112.20 mm3) to 0 mm3 (0, 0 mm3) (p < 0.001), with a VRR of 99.37% ± 4.02%. Two patients developed hoarseness after ablation; one recovered within 10 minutes, and the hoarseness in the other patient resolved 2 months after the ablation. No recurrence, metastatic cervical lymph nodes, or distal metastasis was found during the follow-up period. Conclusions: In this five-year follow-up, MWA presented favorable efficacy with satisfactory safety for the treatment of PTMC. It should be considered an alternative therapy to surgery and active surveillance for solitary PTMC. [ABSTRACT FROM AUTHOR]

Background: Few studies have compared the costs of colorectal endoscopic submucosal dissection (ESD) and endoscopic piecemeal mucosal resection (EPMR).Aims: Here, we aimed to investigate the cost-effectiveness of these approaches by analyzing clinical outcomes and costs.Methods: Data from patients undergoing colorectal ESD and EPMR were retrospectively reviewed. Clinical outcomes (procedure time, complete resection, and recurrence) were compared, and total direct costs (procedural and follow-up) were assessed.Results: Data from 429 ESD and 115 EPMR patients were included in the analysis. The complete resection rate was significantly higher (83.9% vs. 32.2%, p < 0.001), recurrence rate was lower (0.5% vs. 7.1%, p < 0.001), procedure time was longer (55.4 ± 47.0 vs. 25.6 ± 32.7 min, p < 0.001), and total direct procedural costs at the initial resection were higher (1480.0 ± 728.0 vs. 729.8 ± 299.7 USD, p < 0.001) in the ESD group than in the EPMR group. The total number of surveillance endoscopies was higher in the EPMR group (1.7 ± 1.5 vs. 1.3 ± 1.1, p = 0.003). The cumulative total costs of ESD and EPMR were comparable at 3 and 2 years' follow-up in the adenoma and mucosal/superficial submucosal cancer subgroups, respectively.Conclusions: Colorectal ESD was associated with higher complete resection and lower recurrence rates. EPMR showed shorter procedure times and similar cumulative total direct costs. ESD or EPMR should be chosen based on both clinical outcomes and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Background: Little is known about the natural history of perianal fistulas in Asian populations with Crohn's disease (CD).Aims: We investigated the incidence and outcomes of perianal CD (pCD) in Korean CD patients.Methods: A nationwide population-based cohort of 6265 CD patients diagnosed in 2010-2014 was analyzed to investigate the incidence and outcomes of pCD. The results were validated in a hospital-based cohort of 2923 CD patients diagnosed in 1981-2015. Factors associated with pCD development were analyzed. The incidence and outcomes of pCD were compared between the prebiologic and biologic eras.Results: pCD occurred in 39.2% of the population-based cohort and 56.1% of the hospital-based cohort during the median follow-up of 4.2 and 8.5 years, respectively. The cumulative incidence of pCD was 40.0% at 5 years after CD diagnosis in the population-based cohort and 62.5% at 20 years in the hospital-based cohort. In multivariate analysis, pCD development was positively associated with male sex, younger age and colonic involvement at diagnosis, early diagnosis, and CD diagnosis in the prebiologic era. The cumulative probability of proctectomy at 10, 20, and 30 years after pCD diagnosis was 2.9%, 12.2%, and 16.2%, respectively. The cumulative incidence of pCD occurring after CD diagnosis and the cumulative probability of proctectomy were significantly lower in the biologic era than in the prebiologic era (p < 0.001 and p = 0.03, respectively).Conclusions: Compared with Western patients with CD, Korean patients show a high incidence of pCD but have a low probability of proctectomy, suggesting the favorable course of pCD. [ABSTRACT FROM AUTHOR]

Background: Previous randomised trials have shown an overwhelming benefit of mechanical thrombectomy for treating patients with stroke caused by large vessel occlusion of the anterior circulation. Whether endovascular treatment is beneficial for vertebrobasilar artery occlusion remains unknown. In this study, we aimed to investigate the safety and efficacy of endovascular treatment of acute strokes due to vertebrobasilar artery occlusion.Methods: We did a multicentre, randomised, open-label trial, with blinded outcome assessment of thrombectomy in patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China. Patients were randomly assigned (1:1) to endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group). The randomisation sequence was computer-generated and stratified by participating centres. Allocation concealment was implemented by use of sealed envelopes. The primary outcome was a modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis. The primary safety outcome was mortality at 90 days. Secondary safety endpoints included the rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events. The BEST trial is registered with ClinicalTrials.gov, NCT02441556.Findings: Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility. The trial was terminated early after 131 patients had been randomly assigned (66 patients to the intervention group and 65 to the control group) because of high crossover rate and poor recruitment. In the intention-to-treat analysis, there was no evidence of a difference in the proportion of participants with mRS 0-3 at 90 days according to treatment (28 [42%] of 66 patients in the intervention group vs 21 [32%] of 65 in the control group; adjusted odds ratio [OR] 1·74, 95% CI 0·81-3·74). Secondary prespecified analyses of the primary outcome, done to assess the effect of crossovers, showed higher rates of mRS 0-3 at 90 days in patients who actually received the intervention compared with those who received standard medical therapy alone in both per-protocol (28 [44%] of 63 patients with intervention vs 13 [25%] of 51 with standard therapy; adjusted OR 2·90, 95% CI 1·20-7·03) and as-treated (36 [47%] of 77 patients with intervention vs 13 [24%] of 54 with standard therapy; 3·02, 1·31-7·00) populations. The 90-day mortality was similar between groups (22 [33%] of 66 patients in the intervention vs 25 [38%] of 65 in the control group; p=0·54) despite a numerically higher prevalence of symptomatic intracranial haemorrhage in the intervention group.Interpretation: There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone. Results might have been confounded by loss of equipoise over the course of the trial, resulting in poor adherence to the assigned study treatment and a reduced sample size due to the early termination of the study.Funding: Jiangsu Provincial Special Program of Medical Science. [ABSTRACT FROM AUTHOR]

Background Left cardiac sympathetic denervation (LCSD) has been underutilized in patients with hereditary ventricular arrhythmia syndromes such as congenital long QT syndrome (LQTS) and catecholaminergic polymorphic ventricular tachycardia (CPVT). The purpose of this study was to investigate the safety and efficacy of video-assisted thoracoscopic (VATS) LCSD in such patients. Methods Fifteen patients (four men, 24.6 ± 10.5 years old) who underwent VATS-LCSD between November 2010 and January 2015 for hereditary ventricular arrhythmia syndromes at Kyungpook National University Hospital were enrolled in this study. The safety and efficacy of VATS-LCSD were evaluated by periprocedural epinephrine tests and assessing the development of complications and cardiac events during follow-up. Results Fourteen patients with LQTS and one patient with CPVT underwent VATS-LCSD. Six and one patients developed ventricular tachyarrhythmia during preprocedural and postprocedural epinephrine test, respectively (P = 0.063). No serious complications such as Horner syndrome, pneumothorax, or bleeding developed after LCSD. Mean hospital stay after VATS-LCSD was 3.7 ± 1.5 days. During a mean follow-up of 927 ± 350 days, one LQTS patient and one CPVT patient, neither of whom manifested tachyarrhythmia during post-LCSD epinephrine test, developed torsades de pointes and syncope, respectively. The annual event rates of six patients who were symptomatic during the period preceding LCSD decreased from 0.97 to 0.19 events/year (P = 0.045). Conclusions VATS-LCSD was a safe, and effective procedure for patients with hereditary ventricular tachycardia syndrome, with no serious adverse events and with short hospital stay. [ABSTRACT FROM AUTHOR]

Background: The recurrence rate after standard cold forceps polypectomy (CFP) of diminutive polyps of ≤5 mm has not been fully determined. The aim of this study was to analyze the long-term follow-up results and recurrence rate after CFP of diminutive polyps.Methods: We retrospectively reviewed the medical records of 884 (738 men; age 53 years) asymptomatic subjects who underwent surveillance colonoscopy after CFP of 1-2 diminutive adenomatous polyps. Cumulative recurrence at the CFP site and risk factors for recurrence were analyzed.Results: Overall recurrence over 59.7 months was 17 % after CFP of 1111 diminutive polyps. The rate of definite recurrence was 4 %, and probable recurrence was 13 %. Recurrence as advanced adenoma was 0.5 % (5/1111). The cumulative probabilities of recurrence at 3, 5, and 7 years after CFP were 10.0, 16.0, and 21.1 %, respectively. Multivariate analysis revealed that polyp 4-5 mm in size and right colonic polyp were risk factors for recurrence (hazard ratio [HR] 1.37; 95 % confidence interval [CI] 1.01-1.86 and HR 1.49; 95 % CI 1.08-2.04, respectively). The recurrence rate for 10 endoscopists who performed at least 50 CFPs ranged from 11.0 to 25.2 %; the probability of recurrence in those in the top half in terms of recurrence rate was 1.6-fold higher than that of those in the bottom half (95 % CI 1.17-2.19).Conclusions: Although recurrence may develop after standard CFP of diminutive polyps, recurrence as advanced adenoma is rare. Large polyp size, right colon polyp, and endoscopist are risk factors for recurrence after standard CFP. [ABSTRACT FROM AUTHOR]

Pevonedistat is a potent, selective, first-in-class NEDD8 activating enzyme inhibitor. It is now under multiple clinical trials that investigate its anticancer effect against solid tumors and leukemia. ATP-binding cassette (ABC) transporters are membrane proteins that are involved in mediating multidrug resistance (MDR). In this article, we reveal that pevonedistat is a substrate of ABCG2 which decreases the therapeutic effect of pevonedistat. The cytotoxicity of pevonedistat was significantly weakened in ABCG2-overexpressing cells, and the drug resistance can be reversed by ABCG2 inhibitors. The ATPase assay suggested that pevonedistat can stimulate ABCG2 ATPase activity in a concentration-dependent manner. Pevonedistat showed little effect on the expression level or subcellular localization of ABCG2 after 72 h treatment. Furthermore, a pevonedistat resistance cell line S1-PR was established and overexpressed ABCG2. Generally, our study provides evidence that ABCG2 can be a prominent factor leading to pevonedistat-resistance. Furthermore, ABCG2 may also be utilized as a biomarker to monitor the development of pevonedistat resistance during cancer treatment. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to compare 2-year BMI changes between patients undergoing simultaneous bilateral total knee arthroplasty (TKA), staged bilateral TKA, and unilateral TKA. We also sought to determine the predictors of weight change and whether clinically meaningful weight changes affected outcomes. Patients and methods: This retrospective, single-institution study included 202 Chinese patients who received simultaneously bilateral TKA, staged bilateral TKA, or unilateral TKA from 2008 to 2015. There were 49 simultaneous bilateral TKAs, 52 staged bilateral TKAs, and a matched 101 unilateral TKAs. Results: 66.8% (135/202) of patients lost weight after TKA surgery. However, 20.7% (42/202) of patients experienced clinically meaningful weight loss (a BMI decrease of more than 5%). Paired t test showed that 2-year BMI was significantly lower than preoperative BMI (p < 0.001). Weight loss was significantly different between the surgical strategy (p < 0.001). Preoperative BMI and age were predictive of clinically significant weight loss or gain (p < 0.05). Multiple linear regression showed that post-operative weight loss was associated with better Western Ontario and McMaster Universities Osteoarthritis Index and SF-36 scores (p < 0.001). Conclusion: Patients after TKA experience weight loss. Age and preoperative BMI predict clinically meaningful weight change. Simultaneous bilateral TKA is associated with higher likelihood of weight loss. Clinically meaningful weight loss experiences better patient-reported outcomes. [ABSTRACT FROM AUTHOR]