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Clinical outcomes of endoscopic papillectomy of ampullary adenoma: A multi-center study

World Journal of Gastroenterology 2022年第17期28卷 1845-1859页

作者： Seong Ji Choi Hong Sik Lee Jiyeong Kim Jung Wan Choe Jae Min Lee Jong Jin Hyun Jai Hoon Yoon Hyo Jung Kim Jae Seon Kim Ho Soon Choi Department of Internal Medicine Hanyang University College of MedicineSeoul 04763South Korea Division of Gastroenterology and Hepatology Department of Internal MedicineKorea University College of MedicineSeoul 02841South Korea Lab of biostatistical Consulting and Research Medical Research Collaborating CenterIndustry-University Cooperation FoundationHanyang UniversitySeoul 04763South Korea

BACKGROUND Ampullary adenoma is a rare premalignant lesion,but its incidence is increasing.Endoscopic papillectomy has become the first treatment of choice for ampullary adenomas due to its safety and effectiveness,thereby replacing surgical resection.However,recurrence rates and adverse events after endoscopic papillectomy were reported in up to 30%of cases.AIM To review the long-term outcomes of endoscopic papillectomy and investigate the factors that affect these outcomes.METHODS We retrospectively analyzed the data of patients who underwent endoscopic papillectomy for ampullary adenoma at five tertiary hospitals between 2013 and 2020.We evaluated clinical outcomes and their risk factors.The definitions of outcomes were as follow:(1)curative resection:complete endoscopic resection without recurrence;(2)endoscopic success:treatment of ampullary adenoma with endoscopy without surgical intervention;(3)early recurrence:reconfirmed adenoma at the first endoscopic surveillance;and(4)late recurrence:reconfirmed adenoma after the first endoscopic surveillance.RESULTS A total of 106 patients were included for analysis.Of the included patients,81(76.4%)underwent curative resection,99(93.4%)had endoscopic success,showing that most patients with noncurative resection were successfully managed with endoscopy.Sixteen patients(15.1%)had piecemeal resection,22 patients(20.8%)had shown positive/uncertain resection margin,11 patients(16.1%)had an early recurrence,13 patients(10.4%)had a late recurrence,and 6 patients(5.7%)had a re-recurrence.In multivariate analysis,a positive/uncertain margin[Odds ratio(OR)=4.023,P=0.048]and piecemeal resection(OR=6.610,P=0.005)were significant risk factors for early and late recurrence,respectively.Piecemeal resection was also a significant risk factor for non-curative resection(OR=5.424,P=0.007).Twenty-six patients experienced adverse events(24.5%).CONCLUSION Endoscopic papillectomy is a safe and effective treatment for ampullary adenomas.Careful selection and follow-up of patients is mandat

关键词： Endoscopic papillectomy Ampullary adenoma Clinical outcome Recurrence Adverse event

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A systematic review and meta-analysis of clinical trials implementing aromatase inhibitors to treat male infertility

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Asian Journal of Andrology 2020年第4期22卷 360-367页

作者： Francesco Del Giudice Gian Maria Busetto Ettore De Berardinis Isabella Sperduti Matteo Ferro Martina Maggi Martin S Gross Alessandro Sciarra Michael L Eisenberg Department of Urology Sapienza Rome UniversityPoliclinico Umberto IRome 00161Italy biostatistical unit IRCCSRegina Elena National Cancer InstituteRome 00128Italy Division of Urology European Institute of OncologyMilan 20141Italy Section of Urology Dartmouth-Hitchcock Medical CenterLebanonNH 03766USA Department of Urology Stanford UniversitySchool of MedicineStanfordCA 94305USA

Aromatase activity has commonly been associated with male infertility characterized by testicular dysfunction with low serum testosterone and/or testosterone to estradiol ratio.In this subset of patients,and particularly in those with hypogonadism,elevated levels of circulating estradiol may establish a negative feedback on the hypothalamic–pituitary–testicular axis by suppressing follicle-stimulating hormone(FSH)and luteinizing hormone(LH)production and impaired spermatogenesis.Hormonal manipulation via different agents such as selective estrogen modulators or aromatase inhibitors to increase endogenous testosterone production and improve spermatogenesis in the setting of infertility is an off-label option for treatment.We carried out a systematic review and meta-analysis of the literature of the past 30 years in order to evaluate the benefits of the use of aromatase inhibitors in the medical management of infertile/hypoandrogenic males.Overall,eight original articles were included and critically evaluated.Either steroidal(Testolactone)or nonsteroidal(Anastrozole and Letrozole)aromatase inhibitors were found to statistically improve all the evaluated hormonal and seminal outcomes with a safe tolerability profile.While the evidence is promising,future prospective randomized placebo-controlled multicenter trials are necessary to better define the efficacy of these medications.

关键词： aromatase inhibitor hypogonadism male infertility meta-analysis systematic review

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Statistical models for predicting number of involved nodes in breast cancer patients

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Health 2010年第7期2卷 641-651页

作者： Alok Kumar Dwivedi Sada Nand Dwivedi Suryanarayana Deo Rakesh Shukla Center for biostatistical Services Department of Environmental Health College of Medicine University of Cincinnati Cincinnati USA.

Clinicians need to predict the number of involved nodes in breast cancer patients in order to ascertain severity, prognosis, and design subsequent treatment. The distribution of involved nodes often displays over-dispersion—a larger variability than expected. Until now, the negative binomial model has been used to describe this distribution assuming that over-dispersion is only due to unobserved heterogeneity. The distribution of involved nodes contains a large proportion of excess zeros (negative nodes), which can lead to over-dispersion. In this situation, alternative models may better account for over-dispersion due to excess zeros. This study examines data from 1152 patients who underwent axillary dissections in a tertiary hospital in India during January 1993-January 2005. We fit and compare various count models to test model abilities to predict the number of involved nodes. We also argue for using zero inflated models in such populations where all the excess zeros come from those who have at some risk of the outcome of interest. The negative binomial regression model fits the data better than the Poisson, zero hurdle/inflated Poisson regression models. However, zero hurdle/inflated negative binomial regression models predicted the number of involved nodes much more accurately than the negative binomial model. This suggests that the number of involved nodes displays excess variability not only due to unobserved heterogeneity but also due to excess negative nodes in the data set. In this analysis, only skin changes and primary site were associated with negative nodes whereas parity, skin changes, primary site and size of tumor were associated with a greater number of involved nodes. In case of near equal performances, the zero inflated negative binomial model should be preferred over the hurdle model in describing the nodal frequency because it provides an estimate of negative nodes that are at “high-risk” of nodal involvement.

关键词： Nodal Involvement Count Models Breast Cancer

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Clinicopathological differences and correlations between right and left colon cancer

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World Journal of Clinical Cases 2020年第8期8卷 1424-1443页

作者： Ioannis Kalantzis Afroditi Nonni Kitty Pavlakis Eumorphia-Maria Delicha Konstantinos Miltiadou Christos Kosmas Nikolaos Ziras Konstantinos Gkoumas Harikleia Gakiopoulou Department of Gastroenterology Korgialenio-Mpenakeio Hellenic Red Cross HospitalAthens 11526Greece Department of Oncology Metaxa Anticancer HospitalPiraeus 18537Greece First Department of Pathology National and Kapodistrian University of AthensMedical SchoolAthens 11527Greece Independent biostatistical Consultant ASTATStatistics in Clinical ResearchGlyfada 16675Greece Hepatogastroenterology unit Second Department of Internal MedicineAttikon University General HospitalAthens 12462Greece

BACKGROUND The differences in histopathology and molecular biology between right colon cancer(RCC)and left colon cancer(LCC)were first reported in the literature by Bufill in 1990.Since then,a large number of studies have confirmed their differences in epidemiology,clinical presentation,comorbidities and biological behaviours,which may be related to the difference in prognosis and overall survival(OS)between the two groups.AIM To investigate statistically significant differences between Greek patients with LCC and RCC.METHODS The present observational study included 144 patients diagnosed with colon cancer of any stage who received chemotherapy in a Greek tertiary oncology hospital during a 2.5-year period.Clinical information,comorbidities,histopathologic characteristics and molecular biomarkers were collected from the patients’medical records retrospectively,while administered chemotherapy regimens,targeted agents,progression-free survival(PFS)periods with first-and second-line chemotherapy and OS were recorded retroactively and prospectively.Data analysis was performed with the SPSS statistical package.RESULTS Eighty-six males and 58 females participated in the study.One hundred(69.4%)patients had a primary lesion in the left colon,and 44(30.6%)patients had a primary lesion in the right colon.Patients with RCC were more likely to display anaemia than patients with LCC[odds ratio(OR)=3.09],while LCC patients were more likely to develop rectal bleeding(OR=3.37)and a feeling of incomplete evacuation(OR=2.78)than RCC patients.Considering comorbidities,RCC patients were more likely to suffer from diabetes(OR=3.31)and coronary artery disease(P=0.056)than LCC patients.The mucinous differentiation rate was higher in the right-sided group than in the left-sided group(OR=4.49),as was the number of infiltrated lymph nodes(P=0.039),while the percentage of high-grade differentiation was higher in the group of patients with left-sided colon cancer than in RCC patients(OR=2.78).RAS wild-type patients who received anti-epider

关键词： Colorectal neoplasm Epidermal growth factor Vascular endothelial growth factor Histology Molecular biology Metabolic syndrome

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Evidence that chronic hypoxia causes reversible impairment on male fertility

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Asian Journal of Andrology 2008年第4期10卷 602-606页

作者： Vittore Verratti Francesco Berardinelli Camillo Di Giulio Gerardo Bosco Marisa Cacchio Mario Pellicciotta Michele Nicolai Stefano Martinotti Raffaele Tenaglia Department of Medicine and Aging Science University of Chieti Chieti 66013 Italy Department of Basic and Applied Medical Sciences University of Chieti Chieti 66013 Italy biostatistical Office Regina Elena Institute Rome 00144 Italy Laboratorio di Patologia Clinica H University of Chieti Chieti 66013 Italy

Aim： To evaluate the effect of chronic hypoxia on human spermatogenic parameters and their recovery time. Methods： Seminological parameters of six male healthy mountain trekkers were evaluated in normoxia at sea level. After 26 days exposure to altitude （ranging from 2 000 m to 5 600 m, Karakorum Expedition） the same parameters were again evaluated after returning to sea level. These parameters were once again evaluated after 1 month and then again after 6 months. Results： Sperm count was found to be lower immediately after returning to sea level （P = 0.0004） and again after a month （P = 0.0008）. Normal levels were reached after 6 months. Spermatic motility （%） shows no reduction immediately after returning to sea level （P = 0.0583）, whereas after 1 month this reduction was significant （P = 0.0066）. After 6 months there was a recovery to pre-hypoxic exposure values. Abnormal or immature spermatozoa （%） increased immediately after returning to sea level （P = 0.0067） and then again after 1 month （P = 0.0004）. After 6 months there was a complete recovery to initial values. The total number of motile sperm in the ejaculate was found to be lower immediately after returning to sea level （P = 0.0024） and then again after 1 month （P = 0.0021）. After 6 months there was a recovery to pre-hypoxic exposure values. Conclusion： Chronic hypoxia induces a state of oligospermia and the normalization of such seminological parameters at the restoration of previous normoxic conditions after 6 months indicate the influence of oxygen supply in physiological mechanisms of spermatogenesis and male fertility.

关键词： male fertility hypoxia seminological parameters high altitude

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Carotid Intima-media Thickness Measurements： Relations with Atherosclerosis, Risk of Cardiovascular Disease and Application in Randomized Controlled Trials

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Chinese Medical Journal 2016年第2期129卷 215-226页

作者： Michiel L Bots Gregory W Evans Charles H Tegeler Rudy Meijer Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands Department of biostatistical Sciences and Neurology Wake Forest School of Medicine Winston-Salem NC USA Department of Neuiology Ward A Riley Ultrasound Center Wake Forest School of Medicine Medical Center Boulevard Winston-Salem NC USA

Cardiovascular disease （CVD） is the leading cause of death worldwide and contributes considerably to morbidity The underlying cause is atherosclerosisThe development of new preventive therapies is one of the steps to control the CVD epidemic. It is increasingly demanded that promising therapies be evaluated in trials using cardiovascular （CV） morbidity and mortality （M and M） as a primary outcome.

关键词： Atherosclerosis Cardiovascular Disease Prevention Trials

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Magnifying endoscopy for the diagnosis of specialized intestinal metaplasia in short-segment Barrett's esophagus

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World Journal of Gastroenterology 2013年第41期19卷 7089-7096页

作者： Nam Seok Ham Jae Young Jang Sung Woo Ryu Ji Hye Kim Eui Ju Park Woong Cheul Lee Kwang Yeun Shim Soung Won Jeong Hyun Gun Kim Tae Hee Lee Sung Ran Jeon Jun Hyung Cho Joo Young Cho So Young Jin Ji Sung Lee Institution for Digestive Research Digestive Disease CenterDepartment of Internal MedicineSoonchunhyang University HospitalSeoul 140-743South Korea Department of Pathology Soonchunhyang University HospitalSeoul 140-743South Korea biostatistical Consulting unit Soonchunhyang University HospitalSeoul 140-743South Korea

AIM:To determine whether magnified observation of short-segment Barrett’s esophagus(BE)is useful for the detection of specialized intestinal metaplasia(SIM).METHODS:Thirty patients with suspected short-segment BE underwent magnifying endoscopy up to×80.The magnified images were analyzed with respect to their pit-patterns,which were simultaneously classified into five epithelial types[Ⅰ(small round),Ⅱ(straight),Ⅲ(long oval),Ⅳ(tubular),Ⅴ(villous)]by Endo’s classification.Then,a 0.5%solution of methylene blue(MB)was sprayed over columnar mucosa.The patterns of the magnified image and MB staining were analyzed.Biopsies were obtained from the regions previously observed by magnifying endoscopy and MB chromoendoscopy.RESULTS:Three of five patients with a typeⅤ(villous)epithelial pattern had SIM,whereas 21 patients with a non-typeⅤepithelial patterns did not have SIM.The sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of pit-patterns in detecting SIM were 100%,91.3%,92.3%,60%and100%,respectively(P=0.004).Three of the 12 patients with positive MB staining had SIM,whereas 14patients with negative MB staining did not have SIM.The sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of MB staining in detecting SIM were 100%,60.9%,65.4%,25%and100%,respectively(P=0.085).The specificity and accuracy of pit-pattern evaluation were significantly superior compared with MB staining for detecting SIM by comparison with the exact McNemar’s test(P=0.0391).CONCLUSION:The magnified observation of a shortsegment BE according to the mucosal pattern and its classification can be predictive of SIM.

关键词： Short-segment Barrett’s esophagus Magnifying endoscopy Methylene blue chromoendoscopy Specialized intestinal metaplasia Dysplasia Esophageal adenocarcinoma Diagnosis

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Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel： self-reported and autonomic improvements

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Military Medical Research 2018年第1期5卷 1-12页

作者： Catherine L.Tegeler Lee Gerdes Hossam A.Shaltout Jared F.Cook Sean L.Simpson Sung W.Lee Charles H.Tegeler Department of Neurology Wake Forest School of Medicine Medical Center Boulevard Winston-Salem NC 27157 USA Brain State Technologies LLC 15150 North Hayden Road Scottsdale AZ 85260USA Hypertension and Vascular Research Center Wake Forest School of Medicine Medical Center Boulevard Winston-Salem NC 27157USA Department of biostatistical Sciences Wake Forest School of Medicine Medical Center Boulevard Winston-Salem NC 27157 USA

Background:Military-related post-traumatic stress(PTS)is associated with numerous symptom clusters and diminished autonomic cardiovascular regulation.Highresolution,relational,resonance-based,electroencephalic mirroringis a noninvasive,closed-loop,allostatic,acoustic stimulation neurotechnology that produces realtime translation of dominant brain frequencies into audible tones of variable pitch and timing to support the autocalibration of neural oscillations.We report clinical,autonomic,and functional effects after the use offor symptoms of military-related PTS.Methods:Eighteen service members or recent veterans(15 active-duty,3 veterans,most from special operations,1 female),with a mean age of 40.9(SD=6.9)years and symptoms of PTS lasting from 1 to 25 years,undertook19.5(SD=1.1)sessions over 12 days.Inventories for symptoms of PTS(Posttraumatic Stress Disorder Checklist–Military version,PCL-M),insomnia(Insomnia Severity Index,ISI),depression(Center for Epidemiologic Studies Depression Scale,CES-D),and anxiety(Generalized Anxiety Disorder 7-item scale,GAD-7)were collected before(Visit1,V1),immediately after(Visit2,V2),and at 1 month(Visit3,V3),3(Visit4,V4),and 6(Visit5,V5)months after intervention completion.Other measures only taken at V1 and V2 included blood pressure and heart rate recordings to analyze heart rate variability(HRV)and baroreflex sensitivity(BRS),functional performance(reaction and grip strength)testing,blood and saliva for biomarkers of stress and inflammation,and blood for epigenetic testing.Paired t-tests,Wilcoxon signed-rank tests,and a repeated-measures ANOVA were performed.Results:Clinically relevant,significant reductions in all symptom scores were observed at V2,with durability through V5.There were significant improvements in multiple measures of HRV and BRS[Standard deviation of the normal beat to normal beat interval(SDNN),root mean square of the successive differences(rMSSD),high frequency(HF),low frequency(LF),and total power,HF alpha,sequence all,and systolic,diastolic and mean art

关键词： Neurotechnology Allostasis Autonomic Heart rate variability Baroreflex sensitivity Closed-loop Acoustic stimulation Military Post-traumatic stress disorder HIRREM

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Short Term Evaluation of a Novel Eletronic Transanal Irrigation System in Patients with Neurogenic Bowel Dysfunction Previously Exposed to Transanal Irrigation Systems

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Journal of Pharmacy and Pharmacology 2018年第4期6卷 380-394页

作者： Passananti V. Emmanuel A. Nordin M. Storie J. Gripenland j. Astrom M. Hultling C. GI Physiology unit University College London Hospital and National Hospital for Neurology & Neurosurgery London NW1 2BU UK Karolinska University Hospital Department of Neurology Stoekholml 41 86 Sweden biostatistical department StatCons Malm6 126 18 Sweden

Introduction: Neurogenic bowel dysfunction is one of the most distressing consequences of the spinal cord injury. Transanal irrigation has proven to be a treatment for many such individuals, but there are some patients with sub-optimal response to it. Our aim was to evaluate the satisfaction, safety, perception and compliance of a new transanal irrigation device, Navina Smart system featuring an electronically driven pump with a digital control. Material and methods: Twenty-eight patients who had previously used, or were currently using transanal irrigation were enrolled. They were trained to use the Navina Smart system and were thereafter treated for four weeks. Patient perception, compliance and level of satisfaction were assessed at baseline and at the end of treatment. Results: At the end of treatment 68% of patients were still using the system and 50% of ITT (intended to treat) wished to continue using the system. Navina Smart was well tolerated with no adverse effects in the cohort. Patient perception of the Navina Smart system was positive in 67%. Conclusions: Navina Smart system was shown to be safe, tolerable and effective in two-thirds of patients who were unsatisfied with their previous bowel care and was associated with an increase in the patient"s independence.

关键词：灌溉系统机能障碍神经原评估肠灌溉设备数字控制使用系统

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Comparative Study of the Complications of Pedicular Screw Fixation Techniques in the Thoracolumbar Spine: A Systematic Review

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Open Journal of Orthopedics 2023年第8期13卷 343-353页

作者： Vanessa Cavazana Takata João Vitor Lois Balestrieri Pedro Bastos Neto Rodrigo Eduardo Souza Garcia Idiberto José Zotarelli Filho Luis Fernando Ricci Boer Fabiano Morais Nogueira FAMERP-Faculty of Medicine of Sã o José do Rio Preto Orthopedics and Traumatology at Hospital de Base S&atildeo José do Rio Preto S&atildeo Paulo Brazil ABRAN-Brazilian Association of Nutrology Catanduva Sao Paulo Brazil Clinical Research and biostatistical Department College of Palliative Medicine of Sri Lanka Colombo Sri Lanka

Introduction: The use of pedicle screws increases postoperative stability and consolidation of arthrodesis. Pedicle arthrodesis is currently the standard treatment for the thoracolumbar spine, presenting the best fusion and stiffness rates, and among its main indications is the possibility of better correction of spine deformities in the thoracic and lumbar region. However, due to different definitions and the lack of a control group, many of these studies have limited comparative analysis, resulting in the scarcity of comparative studies with standardized methodology. Objective: It was to analyze, through a systematic review, the safety and efficacy of instrumentation with pedicle screws in the spine which have been questioned, despite its wide use for stabilization of the spine, comparing the complications present in the insertion techniques of pedicle screws. Methods: The rules of the Systematic Review-PRISMA were followed. The literary search process was carried out from January to March 2023. A bibliographic search was carried out in MEDLINE, PubMed, and Scielo for articles produced between 2001 and 2023. The quality of the studies was based on the GRADE instrument, and the risk of bias was analyzed according to the Cochrane instrument. The Cohen test (Funnel Plot) and The Heterogeneity Test (Chi-Square Test – X2) were performed, with p Results and Conclusion: A total of 134 articles were found. A total of 67 articles were evaluated in full and 12 were selected to compose the results of this systematic review. According to the GRADE instrument, most studies (X2 = 90.2% > 50%) followed a controlled clinical study model and had a good methodological design, with p < 0.05. It was shown that poor positioning of pedicle screws is the most common cause of complications. The surgeon’s skills and the length and diameter of the pedicle screw can also affect the different modes of placement. Robotic computer assistance has the potential to reduce the incidence of postoperative revisions. Minimall

关键词： Pedicular Arthrodesis Complications Spinal Instrumentation

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