scholarly journals Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study

2021 ◽  
Vol 09 (08) ◽  
pp. E1269-E1275
Author(s):  
Angels Ginès ◽  
Pietro Fusaroli ◽  
Oriol Sendino ◽  
Andrada Seicean ◽  
Antonio Z. Gimeno-Garcia ◽  
...  
Keyword(s):  
Uncinate Process ◽  
Duodenal Perforation ◽  
Technical Failure ◽  
Intention To Treat ◽  
Mean Size ◽  
Site Evaluation ◽  
Solid Lesions ◽  
Number Of Passes ◽  
The Rose

Abstract Background and study aims The poor flexibility of large-bore EUS needles often leads to technical failure when sampling from the duodenum. The aim of this study was to evaluate the technical and diagnostic performances of a new Menghini tip 19G nitinol EUS needle for sampling pancreatic solid lesions in the head and uncinate process. Patients and methods This was a European prospective multicenter single-arm study. A maximum of four passes were allowed. In case of failure, different needles were permitted. Results We included 75 patients (51 % males) with lesions in the head (n = 68; 91 %) and uncinate process (n = 7; 9 %) (mean size: 33 ± 12 mm; number of passes: 1.8 ± 0.9). Technical success was seen in 71 of 75 (94.7 %). Diagnostic rates were 89.3 % (67/75) and 94.4 % (67/71) in the intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. In the eight cases with failure, diagnosis was obtained with another needle (n = 4), from another lesion (n = 3) or with follow-up (n = 1). A histological sample was obtained in 64 patients (ITT 85.3 % and PP 90 %) and immunohistochemistry was successfully performed in 13 of 15 lesions in which it was required. No differences between rapid on-site evaluation (ROSE) and non-ROSE groups were observed regarding diagnostic success (87.5 % vs 91 %, P = 0.582) and diagnosis at the first pass (70 % vs 81 %, P = 0.289). Number of passes was lower in the ROSE group (1.4 + 0.9 vs 2.2 + 0.7, P < 0.001). One adverse event was recorded (1.3 %) consisting in a duodenal perforation after a single session EUS-ERCP. Conclusions The new nitinol Menghini tip 19G EUS needle showed high technical diagnostic success in safely sampling solid lesions in the head and uncinate process of the pancreas.

Therapie alkoholbezogener Störungen im Alter: Ergebnisse der deutschen Stichprobe der randomisiert-kontrollierten ELDERLY-Studie bis zum 12-Monats-Follow-up

2019 ◽  
Vol 65 (2) ◽  
pp. 101-114 ◽  
Author(s):  
Barbara Braun ◽  
Silke Behrendt ◽  
Daniela Piontek ◽  
Ludwig Kraus ◽  
Gerhard Bühringer
Keyword(s):  
Sich Eine ◽  
Complete Case ◽  
Intention To Treat ◽  
Dsm 5

Zusammenfassung. Zielsetzung: Der demographische Wandel lässt eine höhere Anzahl älterer Personen mit Alkoholproblemen erwarten, deren therapeutische Versorgung bislang unzureichend ist. Mit der internationalen, randomisiert-kontrollierten ELDERLY-Studie wurden zwei Varianten einer ambulanten psychotherapeutischen Behandlung für Personen ab 60 Jahren mit einer Alkoholkonsumstörung nach DSM-5 (AS) in drei Ländern erprobt. Methodik: Nach der Baseline-Befragung wurden die zufällig zugeordneten Behandlungsgruppen nach 1, 3, 6 und 12 Monaten erneut untersucht. Erfasst wurden Veränderungen (Zeit und Gruppe) hinsichtlich Trinkmenge, Anzahl abstinenter Tage, Anzahl Tage Rauschtrinken und Tage risikoarmen Konsums sowie Anzahl zutreffender DSM-5-Kriterien für AS. Complete-Case- und Intention-to-treat-Analysen werden für die deutsche Teilstichprobe vorgestellt (n=203). Ergebnisse: Für beide Behandlungsgruppen ergaben sich stabil bis zu 12 Monate nach Baseline ein Anstieg der Abstinenzrate (18 %; t0: 4 %), des Anteils der Personen ohne einen Tag mit riskantem Konsum (45 %, t0: 4 %) sowie ohne Rauschtrinken (68 %, t0: 15 %). Auch zeigte sich eine Verringerung der Trinkmenge (Median bei 27 g Reinalkohol pro Trinktag; t0: 58 g) und Anzahl erfüllter AS-Kriterien (Median bei 2; t0: 5). Schlussfolgerungen: Die Verbesserungen des Trinkverhaltens und der AS-Symptome waren trotz relativ kurzer Behandlungsdauer stabil. Motivierende Interventionen, insbesondere die persönliche Rückmeldung zum Trinkverhalten, bewirken auch bei älteren Personen mit alkoholbezogenen Störungen Verhaltensänderungen. Ein therapeutischer Nihilismus ist unangebracht; vielmehr sollten spezifische Bedürfnisse der Zielgruppe beachtet und in passenden Versorgungsangeboten umgesetzt werden.

Unruptured intracranial aneurysms in children: 18 years’ experience in a tertiary care pediatric institution

2019 ◽  
Vol 24 (2) ◽  
pp. 184-189 ◽  
Author(s):  
Daniel-Alexandre Bisson ◽  
Peter Dirks ◽  
Afsaneh Amirabadi ◽  
Manohar M. Shroff ◽  
Timo Krings ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Natural History ◽  
Internal Carotid Artery ◽  
Intracranial Aneurysms ◽  
Internal Carotid ◽  
Tertiary Care ◽  
Unruptured Intracranial Aneurysms ◽  
History Of ◽  
Mean Size

OBJECTIVEThere are little data in the literature on the characteristics and natural history of unruptured intracranial aneurysms in children. The authors analyzed their experience with unruptured intracranial aneurysms in the pediatric population at their tertiary care pediatric institution over the last 18 years. The first objective was to assess the imaging characteristics and natural history of these aneurysms in order to help guide management strategies in the future. A second objective was to evaluate the frequency of an underlying condition when an incidental intracranial aneurysm was detected in a child.METHODSThe authors conducted a Research Ethics Board–approved retrospective review of incidental intracranial aneurysms in patients younger than 18 years of age who had been treated at their institution in the period from 1998 to 2016. Clinical (age, sex, syndrome) and radiological (aneurysm location, type, size, thrombus, mass effect) data were recorded. Follow-up imaging was assessed for temporal changes.RESULTSSixty intracranial aneurysms occurred in 51 patients (36 males, 15 females) with a mean age of 10.5 ± 0.5 years (range 9 months–17 years). Forty-five patients (88.2%) had a single aneurysm, while 2 and 3 aneurysms were found in 3 patients each (5.8%). Syndromic association was found in 22 patients (43.1%), most frequently sickle cell disease (10/22 [45.5%]). Aneurysms were saccular in 43 cases (71.7%; mean size 5.0 ± 5.7 mm) and fusiform in the remaining 17 (28.3%; mean size 6.5 ± 2.7 mm). Thirty-one aneurysms (51.7%) arose from the internal carotid artery (right/left 1.4), most commonly in the cavernous segment (10/31 [32.3%]). Mean size change over the entire follow-up of 109 patient-years was a decrease of 0.6 ± 4.2 mm (range −30.0 to +4.0 mm, rate −0.12 ± 9.9 mm/yr). Interval growth (2.0 ± 1.0 mm) was seen in 8 aneurysms (13.3%; 4 saccular, 4 fusiform). An interval decrease in size (8.3 ± 10.7 mm) was seen in 6 aneurysms (10%). There was an inverse relationship between aneurysm size and growth rate (r = −0.82, p < 0.00001). One aneurysm was treated endovascularly with internal carotid artery sacrifice.CONCLUSIONSUnruptured pediatric intracranial aneurysms are most frequently single but can occur in multiples in a syndromic setting. None of the cases from the study period showed clinical or imaging signs of rupture. Growth over time, although unusual and slow, can occur in a proportion of these patients, who should be identified for short-term imaging surveillance.

EFFICACY OF TREATMENT OF H.PYLORI EARDICATION WITH STANDARD TRIPLE THERAPY IN PEPTIC ULCER PATIENTS

2011 ◽  
pp. 122-129
Author(s):  
Quang Di Bui ◽  
Phuoc Lam Nguyen
Keyword(s):  
Peptic Ulcer ◽  
Adverse Effects ◽  
Triple Therapy ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Duodenal Ulcers ◽  
Ulcer Disease ◽  
Intention To Treat ◽  
Standard Triple Therapy

Objectives: The aim of study is to evaluate the efficacy, tolerability and adverse effects of a standard triple therapy including Rabeprazole, Clarithromycin and Amoxicilline at Sai gon Hoan My hospital in order to consider treatment H.pylori for patients who have not yet eradicated before or need to be undertaked by alternative regimens. Methods: By descriptive cross-sectional study, the authors have examined 116 patients sufferring from peptic ulcer received 10-day therapy including Rabe (20mg b.d) plus Clari(500mg b.d) plus Amoxi(1g b.d). Eradication is confirmed with endoscopy after 4 weeks from completing of treatment. Results and Discussion: 100% of patients were initially included and noboby was dropped out of the follow-up satges. The mean age was 49 in which 62% was male, 73(62,9%) presented duodenal ulcer, 28(24,1%) gastric ulcer and 15(13%) simultaneous gastric and duodenal ulcers. All patients took medications correctly. Per-protocol and intention to treat eradication rates were both 75%(95% CI=73,4-78,3). Additionally, 62(53,4%) patients had at least one risky factor for peptic ulcer disease, smoking being the most common one 44(37,9%).The adverse effects were reported overall in 67% of the patients, mainly including changed taste, very bitter, tired 49%, trouble sleeping 12% and diarrhea 5%. Conclusion: this ten-day standard triple therapy used in this study is ineffective with high adverse effects.The first line eradication with new regimens should be alternative.

scholarly journals Metformin use and long-term risk of benign prostatic hyperplasia: a population-based cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041875
Author(s):  
Mette Nørgaard ◽  
Bianka Darvalics ◽  
Reimar Wernich Thomsen
Keyword(s):  
Cohort Study ◽  
Benign Prostatic Hyperplasia ◽  
Cox Regression ◽  
Population Based ◽  
Prostatic Hyperplasia ◽  
Haemoglobin A1c ◽  
First Line ◽  
Intention To Treat ◽  
Lowering Drug

ObjectiveTo assess whether metformin use affects risk of benign prostatic hyperplasia (BPH) by comparing the risk of BPH in men with type 2 diabetes who initiated first-line treatment with either metformin or sulfonylurea monotherapy between 2000 or 2006 in Northern Denmark. In this period, sulfonylurea and metformin were both frequently used as first-line glucose-lowering drug (GLD) treatment.DesignA population-based cohort study.SettingNorthern Denmark.ParticipantsAll men who filled at least two prescriptions for metformin or for sulfonylurea, respectively, during their first 6 months of GLD treatment. Follow-up started 6 months after treatment start.Primary outcome measuresRates of subsequent BPH, identified based on community prescriptions for BPH-related treatment or hospital BPH diagnoses, and rates of transurethral resection of the prostate (TURP). Rates in metformin and sulfonylurea users were compared overall and stratified by 6-month haemoglobin A1c (HbA1c) using Cox regression and an intention-to-treat (ITT) approach and an as-treated analysis.ResultsDuring follow-up, less than five persons were lost to follow-up due to emigration. In 3953 metformin initiators with a median follow-up of 10 years, the 10-year cumulative BPH incidence was 25.7% (95% CI 24.2 to 27.1). Compared with 5958 sulfonylurea users (median follow-up 8 years, 10-year cumulative incidence 27.4% (95% CI 26.2 to 28.6)), the crude HR for BPH was 0.83 (95% CI 0.77 to 0.89) and adjusted HR in the ITT analyses was 0.97 (95% CI 0.88 to 1.06). For TURP, the adjusted HR was 0.96 (95% CI 0.63 to 1.46). In the as-treated analysis, adjusted HR for BPH was 0.91 (95% CI 0.81 to 1.02).ConclusionsCompared with sulfonylurea, metformin did not substantially reduce the incidence of BPH in men with diabetes.

scholarly journals Safety and efficacy of polydimethylsiloxane (Macroplastique®) in women with stress urinary incontinence: analysis of data from patients who completed three years follow-up

2021 ◽  
Author(s):  
Gamal Ghoniem ◽  
Bilal Farhan ◽  
Mashrin Lira Chowdhury ◽  
Yanjun Chen
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Medical Centers ◽  
High Satisfaction ◽  
High Satisfaction Rate ◽  
Time Observation ◽  
The Rose

Abstract Introduction and hypothesis This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Methods This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed. Results The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up. Conclusions MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.

Ultrafast Toluidine Blue Staining for Rapid On-Site Evaluation of Cytological Smears

2020 ◽  
Vol 64 (4) ◽  
pp. 375-377
Author(s):  
Ekkehard Hewer ◽  
Anja M. Schmitt
Keyword(s):  
Organic Solvents ◽  
Toluidine Blue ◽  
Critical Factor ◽  
Blue Staining ◽  
Nuclear Morphology ◽  
Hazardous Chemicals ◽  
Toluidine Blue Staining ◽  
Site Evaluation ◽  
The Rose

Rapid on-site evaluation (ROSE) is one of cytopathology’s “unique selling propositions.” The quality, speed, and ease of handling of the staining used is a critical factor for the efficacy of the ROSE procedure. Here, we describe a modification of rapid toluidine blue staining that can be performed within 25 s, provides excellent nuclear morphology, and is compatible with subsequent Papanicolaou staining of the slides. Furthermore, exposure to hazardous chemicals is minimized, as no organic solvents other than the alcohol-based fixative and glycerin for temporary mounting and coverslipping are required. We have used this protocol successfully in our ROSE practice and have not observed any discrepancies between toluidine blue- and permanent Papanicolaou-stained slides.

Late endoscopic evaluation of the ostium size after external dacryocystorhinostomy

2020 ◽  
pp. 112067212097604
Author(s):  
Reem R Al Huthail ◽  
Yasser H Al-Faky
Keyword(s):  
Chart Review ◽  
Retrospective Chart Review ◽  
Tertiary Hospital ◽  
Nasal Endoscope ◽  
Long Term Follow Up ◽  
Mean Size ◽  
External Dacryocystorhinostomy ◽  
The Mean

Objective: To evaluate the effect of chronicity on the size of the ostium after external dacryocystorhinostomy (DCR) with intubation. Methods: Design: A retrospective chart review of patients who underwent external DCR with intubation over 10 years from January 2003 at a tertiary hospital. All patients were recruited and examined with rigid nasal endoscope. Results: A total number of 66 (85 eyes) patients were included. The mean age at the time of evaluation was 53.1 years with gender distribution of 54 females (81.8 %). The mean duration ±SD between the date of surgery and the date of evaluation was 33.2 ± 33.6 (6–118 months). Our study showed an overall anatomical and functional success of 98.8% and 95.3%, respectively. The mean size of the ostium (±SD) was 23.0 (±15.7) mm2 (ranging from 1 to 80.4 mm2). The size of the ostium was not a significant factor for failure ( p = 0.907). No statistically significant correlation was found between the long-term duration after surgery and the size of the ostium ( R: 0.025, p = 0.157). Conclusions: Nasal endoscopy after DCR is valuable in evaluating the ostium with no observed potential correlation between the long-term follow-up after surgery and the size of the ostium.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

308 Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for melanoma

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A335-A335
Author(s):  
Jeffrey Weber ◽  
Paolo Ascierto ◽  
Mark Middleton ◽  
Delphine Hennicken ◽  
Roberto Zoffoli ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Lower Risk ◽  
Phase 3 ◽  
Free Survival ◽  
Intention To Treat ◽  
Risk Of Death ◽  
Link Type ◽  
Indirect Treatment ◽  
Resected Stage

BackgroundWe have previously performed indirect treatment comparisons (ITCs) to demonstrate improvements in recurrence-free survival (RFS) and distant metastasis-free survival with nivolumab versus placebo as adjuvant treatment for resected melanoma; however, overall survival (OS) data were not available at the time. Recently, results of the phase 3 CheckMate 238 trial in patients with resected stage IIIB–IIIC/IV melanoma (American Joint Committee on Cancer [AJCC], 7th edition) showed no statistically significant difference in OS between nivolumab and ipilimumab; however, OS events were fewer than expected. In the phase 3 EORTC 18071 trial in patients with resected stage IIIA–IIIC melanoma (AJCC, 6th edition), OS was improved with ipilimumab versus placebo. Here, we provide an update on RFS and an analysis of OS in ITCs of nivolumab and placebo using data from these 2 trials with a common comparator arm: ipilimumab 10 mg/kg.MethodsITCs of nivolumab versus placebo were conducted using 4-year minimum follow-up data from CheckMate 238 (NCT02388906) and 5.3-year median follow-up data from EORTC 18071 (NCT00636168). Bucher ITCs were performed to estimate RFS and OS in the intention-to-treat populations. A sensitivity analysis of OS adjusting for subsequent therapy options was conducted in 2 steps: (1) after controlling for possible confounders and assuming that the only difference was the effect of different subsequent therapies, postrecurrence survival was compared between the 2 ipilimumab arms in each study, and (2) after adjusting for differences in postrecurrence survival, ITCs of nivolumab versus adjusted placebo were performed.ResultsIn these ITC analyses, RFS and OS results with nivolumab suggested an improvement compared with placebo. In the intention-to-treat population, nivolumab was associated with a lower risk of recurrence or death (RFS HR, 0.55; 95% CI, 0.43–0.70) and a lower risk of death (OS HR, 0.62; 95% CI, 0.44–0.88) than placebo. In the sensitivity analysis, a 63% average increase in postrecurrence survival benefit was estimated with ipilimumab in CheckMate 238 compared with ipilimumab in EORTC 18071. After adjusting for this increase in both the ipilimumab and placebo arms in EORTC 18071, nivolumab was associated with a lower risk of death than placebo (OS HR, 0.65; 95% CI, 0.45–0.91), similar to the unadjusted analysis.ConclusionsDespite the changing treatment landscape and the increased number of therapeutic options for metastatic melanoma, these ITCs suggested clinically meaningful improvement in RFS and OS with adjuvant nivolumab compared with a wait-and-watch strategy in high-risk patients with resected melanoma.AcknowledgementsWriting and editorial assistance were provided by Kakoli Parai, PhD, and Andrea Lockett of Ashfield Healthcare Communications, funded by Bristol-Myers Squibb Company.Trial RegistrationNCT02388906 (CheckMate 238), NCT00636168 (EORTC 18071)

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