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1.
Am J Hematol ; 2020 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-33306213

RESUMO

Historically, double or triple hit lymphoma (DHL and THL) have poor outcome with conventional chemotherapy, but there is currently no guideline. We report the French experience in managing DHL and THL in first line using collective data on both survival and tolerance. All consecutive patients with newly diagnosis of large B-cell lymphoma with MYC, BCL2, and/or BCL6 rearrangements, as determined by FISH between January 2013 and April 2019 were included. Based on the eligibility criteria, 160 patients were selected among the 184 patients identified. With a median follow-up of 32 months, 2-year and 4-year progression free survival (PFS) rates were 40% and 28% with R-CHOP compared with 57% and 52% with intensive chemotherapy (P = .063). There was no difference in overall survival (OS). For advanced stages, PFS was significantly longer with intensive chemotherapy than with R-CHOP (P = .029). There was no impact of autologous stem cell transplantation among patient in remission. For patient with central nervous system (CNS) involvement, 2-year PFS and OS rate was 21 % and 39 %, versus 57% and 75 % without CNS disease (P = .007 and P <.001). By multivariate analysis, elevated IPI score and CNS disease were strongly and independently associated with a poorer survival, whereas treatment was not significantly associated with OS. This is the largest series reporting the treatment of DHL and THL in Europe. PFS was significantly longer with an intensive regimen for advanced stage, but no difference in OS, supporting the need for a prospective randomized trial. This article is protected by copyright. All rights reserved.

2.
Blood ; 2020 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-33167024

RESUMO

Trials assessing first-line, fixed-duration approaches in chronic lymphocytic leukemia (CLL) are yielding promising activity, but few long-term data are available. We report follow-up data from a phase 2 trial (ICLL-07 FILO; NCT02666898) in previously untreated, medically-fit patients (N=135). Patients underwent obinutuzumab-ibrutinib induction for 9 months; then, following evaluation (N=130 evaluable), those in complete remission and with bone marrow measurable residual disease (BM MRD) <0.01% (n=10) received ibrutinib for 6 additional months, while those in partial remission and/or with BM MRD ≥0.01% - the majority (n=120) - also received 4 cycles of immunochemotherapy (fludarabine/cyclophosphamide-obinutuzumab). Beyond end of treatment, responses were assessed 3 monthly and peripheral blood MRD 6 monthly. At median follow-up 36.7 months from treatment start, progression-free and overall survival rates (95% confidence interval) at 3 years were 95.7% (92.0 to 99.5) and 98% (95.1 to 100), respectively. Peripheral blood MRD <0.01% rates were 97%, 96%, 90%, 84%, and 89% at months 16, 22, 28, 34, and 40, respectively. No new treatment-related or serious adverse event occurred beyond end of treatment. Thus, in previously untreated, medically-fit patients with CLL, a fixed-duration (15 months), MRD-guided approach achieved high survival rates, a persistent MRD benefit beyond the end of treatment, and low long-term toxicity.

3.
Orthod Fr ; 91(3): 179-190, 2020 10 01.
Artigo em Francês | MEDLINE | ID: mdl-33146613

RESUMO

Once the orthodontic retention phase is complete, a number of patients return to the office following retainer detachment or complaining about the stability of the result. The aim of this study was to search for predictors of re-consultation and to evaluate how the choice of retainer impacts re-consultation for misalignment or debonding. A systematic retrospective cohort study was conducted ten years after removal of orthodontic appliances. Of the 380 patients included, 23% re-consulted on average 4.5 years after appliance removal. The patients most likely to re-consult were those with a severe initial aesthetic deficit. Mandibular retainers bonded on six teeth resulted in three-fold more re-consultations than wires bonded exclusively on the canines, but the difference was non-significant. Mandibular retainers bonded on the canines certainly generated significantly more maintenance appointments than the six-teeth retainers, but fewer malposition problems (non-significant result). These results raise questions regarding indications for bonded maxillary retainers as opposed to removable devices and also regarding the management of long-term post-retention follow-up.


Assuntos
Mandíbula , Contenções Ortodônticas , Humanos , Desenho de Aparelho Ortodôntico , Recidiva , Encaminhamento e Consulta , Estudos Retrospectivos
4.
Orthod Fr ; 91(3): 225-238, 2020 10 01.
Artigo em Francês | MEDLINE | ID: mdl-33146617

RESUMO

The treatment of mandibular asymmetry often requires a late surgical orthodontic protocol that certainly allows an improvement but no complete correction. Ideal would be to control the etiological factors which are still controversial. The aim of the study is to identify per and postnatal factors associated with the development of mandibular asymmetry. This case-control study was performed with a cohort of 100 individuals divided in two subgroups. A subgroup of 50 subjects with mandibular asymmetry and another subgroup of 50 subjects without mandibular asymmetry. The subjects included in the study had to be from 6 to 16 years old, have a complete orthodontic file and no congenital syndrom or pathology. The following factors have been assessed: gender, mode and date of birth, dental trauma, visual disorders, ENT problems and parafunctions. An inter-group comparison had been performed by using statistical tests (Chisquare test, Fisher test and odds ratios calculation). The associated factors with mandibular asymmetry are male gender, oral ventilation, short-term vaginal nasalization, dental trauma and visual disorders. Asthma (symmetrical character of the anomaly ?), prematurity and caesarean section (by absence of trauma at delivery ?) would not be considered as associated factors. This case-control study is a first-line study that allows the identification of factors that may be associated with mandibular asymmetry. Ideally, a larger-scale prospective cohort study to increase the pertinence would clarify the risk factors for the development of mandibular asymmetry.


Assuntos
Cesárea , Assimetria Facial , Adolescente , Estudos de Casos e Controles , Cefalometria , Criança , Assimetria Facial/epidemiologia , Assimetria Facial/etiologia , Feminino , Humanos , Masculino , Mandíbula , Gravidez , Estudos Prospectivos
5.
Pediatr Nephrol ; 2020 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-32901297

RESUMO

INTRODUCTION: In nephropathic cystinosis (NC), adherence to cysteamine remains challenging; poor adherence is worsening the disease progression with a decline of kidney function and increase of extrarenal morbidities. Our objective was to describe adherence to cysteamine in NC patients, using electronic monitoring systems. METHODS: Patients with confirmed NC, aged > 4 years and receiving oral cysteamine (short acting or delayed release formulation as standard of care) from 3 French reference centers, were included. Adherence to treatment was primarily assessed as the percentage of days with a good adherence score, adherence score rating from 0 (poor) to 2 (good). A descriptive analysis was performed after 1-year follow-up. RESULTS: Seventeen patients (10 girls, median age: 13.9 (5.4-33.0) years) were included. Median age at diagnosis was 17.0 (3.0-76.9) months and age at start of cysteamine was 21.0 (15.5-116.3) months. Median daily dose of cysteamine was 1.05 (0.55-1.63) g/m2/day. Over the year, the median percentage of days with a good adherence score was 80 (1-99)% decreasing to 68 (1-99)% in patients > 11 years old. The median of average number of hours covered by treatment in a day was 22.5 (6.1-23.9) versus 14.9 (9.2-20.5) hours for delayed release versus short acting cysteamine. CONCLUSION: Our data are the first describing a rather good adherence to cysteamine, decreasing in adolescents and adults. We described a potential interest of the delayed release formulation. Our data highlight the need for a multidisciplinary approach including therapeutic education and individualized approaches in NC patients transitioning to adulthood. Graphical abstract.

6.
Arthritis Rheumatol ; 2020 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-32892515

RESUMO

BACKGROUND: Patients with systemic sclerosis (SSc) and both pulmonary hypertension (PH) and interstitial lung disease (ILD) (SSc-PH-ILD) generally carry a worse prognosis than patients with SSc and pulmonary arterial hypertension (PAH) without ILD (SSc-PAH). There is no evidence of the efficacy of PAH therapies in PH-ILD. OBJECTIVE: To compare survival and response to treatment of patients with SSc-PH-ILD and those with SSc-PAH. METHODS: We analysed 128 patients (66 SSc-PH-ILD, 62 SSc-PAH) from 15 centers, whose PH was diagnosed by right heart catheterization, prospectively included in the PH registry . All patients received PAH specific therapy. Computed tomography of the chest was used to confirm or exclude ILD. RESULTS: At baseline, patients with SSc-PH-ILD had less severe hemodynamic impairment (pulmonary vascular resistance, 5.7 compared to 8.7 WU, p=0.0005) and lower carbon monoxide diffusion capacity (median, 25%, Q1-Q3 18-35%, versus 40, Q1-Q3 31-51, p=0.0005) than those with SSc-PAH. Patients with SSc-PH-ILD had an increased mortality (8.1%, 21.2% and 41.5% at 1, 2 and 3 years) as compared to SSc-PAH (4.1%, 8.7% and 21.4%, p=0.04). Upon treatment with PAH-targeted therapy, no improvement was found in either group in six-minute walking distance. Improvement of WHO functional class was observed less frequently in patients with SSc-ILD-PH than in those with SSc-PAH (13.6% versus 33.3%, p=0.02); hemodynamics improved similarly in both groups. CONCLUSION: ILD confers a worse prognosis to SSc-PH. Response to PAH specific therapy is poor clinically in SSc-PH-ILD but was not found hemodynamically different from that observed in SSc-PAH.

7.
Crit Care Med ; 48(11): 1572-1579, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32885939

RESUMO

OBJECTIVES: To evaluate the diagnostic accuracy of the Impact Event Scale-Revisited assessed following ICU discharge to predict the emergence of post-traumatic stress disorder symptoms at 3 months. DESIGN: Prospective cohort study. SETTING: Three medical or surgical ICU of a French university hospital (Lyon, France). PATIENTS: Patients greater than or equal to 18 years old, leaving ICU after greater than or equal to 2 nights of stay, between September 2017 and April 2018. INTERVENTIONS: Patients completed the Impact Event Scale-Revisited and the Peritraumatic Dissociative Experiences Questionnaire within 8 days after ICU discharge and the Impact Event Scale-Revisited again at 3 months by phone. Patients having an Impact Event Scale-Revisited greater than or equal to 35 at 3 months were considered as having post-traumatic stress disorder symptoms. MEASUREMENTS AND MAIN RESULTS: Among the 208 patients screened, 174 were included and 145 reassessed by phone at 3 months. Among the patients included at baseline, 43% presented symptoms of acute stress. At 3 months, 13% had an Impact Event Scale-Revisited greater than or equal to 35 and 17% had a score between 12 and 34. Regarding the performance of the Impact Event Scale-Revisited performed within 8 days after the ICU discharge to predict post-traumatic stress disorder symptoms at 3 months, the area under the curve was 0.90 (95% CI, 0.80-0.99), and an Impact Event Scale-Revisited greater than or equal to 12 had a sensitivity of 90%, a specificity of 71%, a positive predictive value of 32%, and a negative predictive value of 98%. History of anxiety disorder odds ratio = 3.7 (95% CI, 1.24-11.05; p = 0.02) and Impact Event Scale-Revisited greater than or equal to 12 odds ratio = 16.57 (95% CI, 3.59-76.46; p < 0.001) were identified as risk factors for post-traumatic stress disorder symptoms. CONCLUSIONS: Impact Event Scale-Revisited assessed at ICU discharge has a good ability for the detection of patients at risk of developing post-traumatic stress disorder symptoms. Patients with history of anxiety disorder and those presenting acute stress symptoms at ICU discharge are more at risk to develop post-traumatic stress disorder symptoms.

8.
J Gynecol Obstet Hum Reprod ; : 101874, 2020 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-32687891

RESUMO

OBJECTIVES: The aim of this study was to evaluate the results of in vitro fertilization (IVF) and intrauterine insemination (IUI) in a population of infertile women with low AMH levels, in whom both techniques were possible. METHODS: This was a retrospective analysis of 462 patients treated over 24 months in a single center comparing the live birth rates after 176 IUI and 639 IVF attempts in infertile couples. The women had AMH levels ≤ 1.2 ng/mL and at least one patent tube and their partner's sperm was of sufficient quality for IUI. RESULTS: The live birth rate after IVF was not sufficiently higher than after IUI, or than after IVF attempts converted to IUI for low response (odds ratios in multivariate analysis with respect to IVF: 0.61, p = 0.15 for IUI and 0.73, p = 0.6 for conversions). The pregnancy rates after IVF (13.0 %) and IUI (13.3 %) were similar (p = 0.4), and were non-significantly higher than the pregnancy rate in the IUI conversion group (8.8 %, p = 0.9). Nearly half (43.8 %) of all IVF cycles did not lead to embryo transfer. CONCLUSION: In this group of women with AMH levels ≤ 1.2 ng/mL, IVF did not lead to a higher live birth rate than IUI, and more than 40 % of all IVF attempts did not lead to embryo transfer, suggesting that diminished ovarian reserve is not an indication for IVF over IUI.

9.
Fam Pract ; 37(5): 668-674, 2020 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-32531028

RESUMO

BACKGROUND: Minimal data are available on the clinical activity of general practitioners (GPs) in Africa. OBJECTIVE: To describe the health problems managed by GPs in Mali as compared with France where epidemiological transition is already advanced. METHODS: A retrospective, multicenter study, conducted in five Malian Community Health Centers. We compared their consultation data to those of the ECOGEN (Eléments de la COnsultation en médecine GENérale) study conducted in 128 French general practices, after data standardization for age and sex. RESULTS: Malian and French databases included 19 068 and 19 341 consultations, respectively. Patients had an average of 1.2 health problems managed per consultation in Mali, versus 2.2 in France. They were dominated by infections (51.3%) in Mali, including malaria (24.9%), pneumonia (9.0%) and gastrointestinal infections (5.0%). In comparison with French GPs, Malian GPs more frequently managed cardiovascular (20.2% versus 13.5%), respiratory (15.0% versus 12.4%) and digestive (13.3% versus 7.8%) problems, and less frequently musculoskeletal (3.1% versus 12.6%), endocrine/metabolic (1.5% versus 10.7%) and psychological (0.2% versus 8.2%) problems. The main activity performed by French GPs was prevention (11.0%), which was nominal in Mali. Apart from hypertension, which accounted for 18.9% of the health problems managed in Mali, chronic conditions were less often managed by Malian GPs than by French GPs (12.3% versus 39.6%). CONCLUSIONS: Africa is currently at the crossroads where chronic conditions carried with the epidemiological transition are progressing, while the burden of communicable diseases is still overwhelming. Along with the enhancing medicalization of primary care in Mali, the transition of practices is just emerging.

10.
J Clin Sleep Med ; 16(9): 1507-1515, 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32406372

RESUMO

STUDY OBJECTIVES: First, to determine whether the 3-item Observation and Interview-based Diurnal Sleepiness Inventory (ODSI) measures the degree of excessive daytime sleepiness in patients with suspected narcolepsy or idiopathic hypersomnia (IH). Second, to assess the correlation between the ODSI and the Epworth Sleepiness Scale (ESS) as well as objective polysomnographic measurements. Third, to test the accuracy of the ODSI to detect narcolepsy or IH (narcolepsy/IH) compared with the ESS. METHODS: A total of 181 patients complaining of excessive daytime sleepiness filled in the ESS and the ODSI and underwent measurements including actigraphy, full-night polysomnography, Multiple Sleep Latency Test, and 24-hour bedrest sleep recording. RESULTS: Narcolepsy or IH was diagnosed in 76 patients. The ODSI found excessive daytime sleepiness in 92.3% of all patients and in 98.7% of those diagnosed with narcolepsy/IH. In the whole population, the ODSI was significantly positively correlated with the ESS (R = .547; 95% confidence interval: .436, .642; P < .001) and weakly with 24-hour total sleep time on bedrest recording (R = .208; 95% confidence interval: .056, .350; P = .047) but not with the Multiple Sleep Latency Test. The ODSI offered a higher negative (92.9%) and positive (44.9%) predictive value to detect narcolepsy/IH than did the ESS (66.7% and 43.3%, respectively). In the IH group, the ODSI's third-item score (daily sleepiness duration) was significantly higher in patients with than without increased 24-hour total sleep time (P = .023). CONCLUSIONS: The ODSI is a brief, simple first-line questionnaire that explores both intensity and duration of daytime sleepiness and offers a high sensitivity to detect narcolepsy and IH.

11.
JMIR Res Protoc ; 9(7): e17232, 2020 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-32449505

RESUMO

BACKGROUND: The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. OBJECTIVE: The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. METHODS: This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. RESULTS: This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. CONCLUSIONS: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. TRIAL REGISTRATION: Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17232.

13.
Biom J ; 62(6): 1476-1493, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32346912

RESUMO

Treatment selection markers are generally sought for when the benefit of an innovative treatment in comparison with a reference treatment is considered, and this benefit is suspected to vary according to the characteristics of the patients. Classically, such quantitative markers are detected through testing a marker-by-treatment interaction in a parametric regression model. Most alternative methods rely on modeling the risk of event occurrence in each treatment arm or the benefit of the innovative treatment over the marker values, but with assumptions that may be difficult to verify. Herein, a simple non-parametric approach is proposed to detect and assess the general capacity of a quantitative marker for treatment selection when no overall difference in efficacy could be demonstrated between two treatments in a clinical trial. This graphical method relies on the area between treatment-arm-specific receiver operating characteristic curves (ABC), which reflects the treatment selection capacity of the marker. A simulation study assessed the inference properties of the ABC estimator and compared them with other parametric and non-parametric indicators. The simulations showed that the estimate of the ABC had low bias, power comparable to parametric indicators, and that its confidence interval had a good coverage probability (better than the other non-parametric indicator in some cases). Thus, the ABC is a good alternative to parametric indicators. The ABC method was applied to data of the PETACC-8 trial that investigated FOLFOX4 versus FOLFOX4 + cetuximab in stage III colon adenocarcinoma. It enabled the detection of a treatment selection marker: the DDR2 gene.

14.
Neuroendocrinology ; 2020 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-32335556

RESUMO

INTRODUCTION: The characteristics, prognostic factors, and management of duodenal neuroendocrine neoplasms (dNEN) are ill-defined given their rarity. Whether non-surgical management could be appropriate in good-prognosis non-metastatic dNEN, as for pancreatic NEN (pNEN), is unknown. We aimed to describe the management and prognosis of non-metastatic dNEN patients. METHODS: All consecutive patients with non-metastatic dNEN managed between 1981 and 2018 in two expert centers were included. Recurrence-free survival (RFS) and factors associated with recurrence were estimated. RESULTS: A total of 145 patients with dNEN were included. Twenty-eight sporadic, non-functioning, small (median size: 7mm), dNEN underwent endoscopic resection, with a 5-year recurrence-free survival rate of 89.4%. Local recurrence occurred in two patients, who underwent surgery without new event. The 5-year recurrence-free rate was 87.9% in patients who underwent surgery. In univariate analysis, age, size, Ki67, and lymph-node involvement were significantly associated with worse RFS for all treated (endoscopy/surgery) dNEN; multivariate analysis found age, size, and lymph-node involvement were associated with worse RFS. CONCLUSION: Selected non-metastatic dNEN had a favorable outcome and appear suitable for a less invasive therapeutic strategy than oncological surgery.

15.
Therapie ; 75(2): 169-173, 2020 Apr.
Artigo em Francês | MEDLINE | ID: mdl-32248985

RESUMO

Rare diseases usually concern small and disseminated population. Implementing clinical research with the right design, outcomes measures and the recruitment of patients are challenges. Collaborations, training and multidisciplinary approach are often required. In this article, we provide an overview of a successful collaboration in nephropathic cystinosis (NC), focusing on what was the key of success, the interactions between academics, the pharmaceutical company and patients organizations. NC is considered as a very rare disease. In 2010, a new formulation of cysteamine, the only available treatment to improve renal outcome of the disease, was proposed by a small American company. Studies were implemented in France under the coordination of an expert of the disease and the clinical investigation center of Lyon. The collaboration resulted in a good recruitment and retention of the patients in the study and most of all in the availability of the new formulation in France. Patients could have facilitated the research by being involved in the early stages of the studies. Involving patients and public early in the process is particularly important in rare diseases as the patient is a great source of knowledge and has his own expectations. Priorities of research, design, conduct and reporting of clinical trials can be defined in collaboration with adults but also with young patients or public, the first concerned in rare diseases. This concept is still to be developed and improved especially with paediatric patients.

16.
J Clin Med ; 9(3)2020 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-32183257

RESUMO

It is well known that thyroid dysfunction increases with age. This study is aimed to determine reference intervals, in males and females, suitable for thyroid disease exploration during adult life using routinely collected serum thyrotropin (TSH) data in a tertiary center from 2007 to 2018. Over 11 years, 295,775 TSH levels were measured in a single lab. Among the 156,025 TSH results available for analysis, 90,538 values were from female subjects, 82,019 were from patients aged >60 years and 26,825 were from patients aged >80 years. By using an indirect approach, we determined reference values of TSH adapted to age and sex, and we then evaluated the proportion of patients who would have been reclassified with these reference values. The median TSH ranged from 1.2-1.4 mUI/L during the study period. The upper limit of reference range of TSH increased with age; in females the median to 97.5th percentile values increased continuously from the age of 30 years to the oldest age group. Using new calculated reference values in patients with TSH above the conventional upper-limit reference value (4 mUI/L), the proportion of results reclassified as within the reference interval among patients aged >60 years ranged, according to age group, from 50.5% to 65.1% of females and from 33.0% to 37.7% of males. The use of TSH age-specific and sex-specific upper-limit reference values led to the reclassification of a great number of samples, notably among women. This suggests that age-specific TSH upper-limit reference intervals in daily practice should be used in order to avoid misclassification.

17.
Endoscopy ; 52(6): 444-453, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32120411

RESUMO

BACKGROUND: Gastric hyperplastic polyps (GHPs) have a risk of neoplastic transformation reaching 5 %. Current endoscopic resection techniques appear suboptimal with a high risk of local recurrence. This study assessed the outcomes of endoscopic resection for GHPs and identified risk factors for recurrence and neoplastic transformation. METHODS: This retrospective, multicenter, European study included adult patients with at least one GHP ≥ 10 mm who underwent endoscopic resection and at least one follow-up endoscopy. Patients with recurrent GHPs or hereditary gastric polyposis were excluded. All data were retrieved from the endoscopy, pathology, and hospitalization reports. RESULTS: From June 2007 to August 2018, 145 GHPs in 108 patients were included. Recurrence after endoscopic resection was 51.0 % (74 /145) in 55 patients. R0 resection or en bloc resection did not impact the risk of polyp recurrence. In multivariate analysis, cirrhosis was the only risk factor for recurrence (odds ratio [OR] 4.82, 95 % confidence interval [CI] 1.33 - 17.46; P = 0.02). Overall, 15 GHPs (10.4 %) showed neoplastic transformation, with size > 25 mm (OR 10.24, 95 %CI 2.71 - 38.69; P < 0.001) and presence of intestinal metaplasia (OR 5.93, 95 %CI 1.56 - 22.47; P = 0.01) being associated with an increased risk of neoplastic transformation in multivariate analysis. CONCLUSIONS: Results confirmed the risk of recurrence and neoplastic transformation of large GHPs. The risk of neoplastic change was significantly increased for lesions > 25 mm, with a risk of high grade dysplasia appearing in polyps ≥ 50 mm. The risk of recurrence was high, particularly in cirrhosis patients, and long-term follow-up is recommended in such patients.

18.
Endoscopy ; 52(5): 383-388, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32032969

RESUMO

BACKGROUND: Endoscopic submucosal dissection (ESD) of residual or locally recurrent (RLR) colonic lesions after previous endoscopic mucosal resection (EMR) is an attractive but challenging technique. The present study aimed to evaluate the effectiveness and safety of ESD with double clip and rubber band traction (DCT-ESD) of RLR colonic lesions. METHODS: We retrospectively analyzed all consecutive DCT-ESD procedures for RLR colonic lesions (rectum excluded) performed in two French centers. The frequency of en bloc and R0 resections, procedure speed, additional surgery, and complications were evaluated. R0 resection was also used to investigate the learning curve. RESULTS: Among the 53 resections, 49 (92.5 %) were performed en bloc and 42 (79.2 %) achieved R0. The median procedure speed was 21 mm2/min. There were four (7.5 %) intraoperative perforations and one delayed bleeding; these were successfully treated endoscopically. There was no salvage surgery for complications. The R0 rate increased from 16/26 (61.5 %) for the first 26 procedures to 26/27 (96.3 %, P = 0.002) for the last 27 procedures. CONCLUSIONS: DCT-ESD appears to be a safe and effective treatment for RLR colonic lesions after EMR.

19.
Stat Methods Med Res ; 29(1): 29-43, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30599802

RESUMO

The use of a quantitative treatment selection marker to choose between two treatment options requires the estimate of an optimal threshold above which one of these two treatments is preferred. Herein, the optimal threshold expression is based on the definition of a utility function which aims to quantify the expected utility of the population (e.g. life expectancy, quality of life) by taking into account both efficacy (success or failure) and toxicity of each treatment option. Therefore, the optimal threshold is the marker value that maximizes the expected utility of the population. A method modelling the marker distribution in patient subgroups defined by the received treatment and the outcome is proposed to calculate the parameters of the utility function so as to estimate the optimal threshold and its 95% credible interval using the Bayesian inference. The simulation study found that the method had low bias and coverage probability close to 95% in multiple settings, but also the need of large sample size to estimate the optimal threshold in some settings. The method is then applied to the PETACC-8 trial that compares the efficacy of chemotherapy with a combined chemotherapy + anti-epidermal growth factor receptor in stage III colorectal cancer.

20.
Endosc Int Open ; 7(11): E1496-E1502, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31673623

RESUMO

Background Endoscopic mucosal resection (EMR) with snare is the recommended technique to resect non-invasive colorectal neoplastic lesions between 10 and 30 mm in diameter. The objective of EMR is to resect completely the neoplastic tissue en bloc and preferably with free margins (R0), avoiding recurrences. Anchoring the tip of the snare in the submucosa is a technical trick that allows snare sliding to be reduced and larger pieces to be caught. The aim of the present study was to evaluate the effectiveness and safety of anchoring-EMR (A-EMR). Methods This was a retrospective analysis of A-EMR procedures for lesions of diameter between 10 and 30 mm (endoscopic evaluation) performed consecutively in four French centers between May 2017 and January 2018. A-EMR was routinely performed for all EMR using Olympus conventional snares (10 or 25 mm). The primary outcome was evaluation of the proportion of R0 resections. Results A total of 141 A-EMR procedures were performed by 10 operators. Mean lesion size was 19.8 mm. Anchoring was feasible in 96.5 % of cases. There were 81.6 % en bloc resections and 70.2 % R0 resections, with the percentage of procedures decreasing with increasing lesion size (82.8 % < 20 mm, 55.3 % 21 - 30 mm, and 50.0 % > 30 mm, P  = 0.002). Complete perforations closed endoscopically occurred in 3/141 cases (2.1 %); none occurred in lesions < 20 mm in size (0 /87). Conclusion The A-EMR technique appears to be promising with a high proportion of R0 for lesions of 10 - 20 mm in size without any perforations. It could also offer an alternative to endoscopic submucosal dissection (ESD), or to hybrid techniques to reach R0 for lesions between 20 and 30 mm in size.

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