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1.
Ann Surg Oncol ; 2024 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-39120839

RESUMO

BACKGROUND: Pancreatic adenocarcinoma located in the pancreatic body might require a portomesenteric venous resection (PVR), but data regarding surgical risks after distal pancreatectomy (DP) with PVR are sparse. Insight into additional surgical risks of DP-PVR could support preoperative counseling and intraoperative decision making. This study aimed to provide insight into the surgical outcome of DP-PVR, including its potential risk elevation over standard DP. METHODS: We conducted a retrospective, multicenter study including all patients with pancreatic adenocarcinoma who underwent DP ± PVR (2018-2020), registered in four audits for pancreatic surgery from North America, Germany, Sweden, and The Netherlands. Patients who underwent concomitant arterial and/or multivisceral resection(s) were excluded. Predictors for in-hospital/30-day major morbidity and mortality were investigated by logistic regression, correcting for each audit. RESULTS: Overall, 2924 patients after DP were included, of whom 241 patients (8.2%) underwent DP-PVR. Rates of major morbidity (24% vs. 18%; p = 0.024) and post-pancreatectomy hemorrhage grade B/C (10% vs. 3%; p = 0.041) were higher after DP-PVR compared with standard DP. Mortality after DP-PVR and standard DP did not differ significantly (2% vs. 1%; p = 0.542). Predictors for major morbidity were PVR (odds ratio [OR] 1.500, 95% confidence interval [CI] 1.086-2.071) and conversion from minimally invasive to open surgery (OR 1.420, 95% CI 1.032-1.970). Predictors for mortality were higher age (OR 1.087, 95% CI 1.045-1.132), chronic obstructive pulmonary disease (OR 4.167, 95% CI 1.852-9.374), and conversion from minimally invasive to open surgery (OR 2.919, 95% CI 1.197-7.118), whereas concomitant PVR was not associated with mortality. CONCLUSIONS: PVR during DP for pancreatic adenocarcinoma in the pancreatic body is associated with increased morbidity, but can be performed safely in terms of mortality.

2.
Surg Endosc ; 2024 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-39342074

RESUMO

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) has emerged as an alternative to open pancreatoduodenectomy (OPD). However, the extent of variation in the use and outcomes of MIPD in relation to OPD among countries is unclear as international studies using registry data are lacking. This study aimed to investigate the use, patient selection, and outcomes of MIPD and OPD in four transatlantic audits for pancreatic surgery. METHODS: A post hoc comparative analysis including consecutive patients after MIPD and OPD from four nationwide and multicenter pancreatic surgery audits from North America, Germany, the Netherlands, and Sweden (2014-2020). Patient factors related to MIPD were identified using multivariable logistic regression. Outcome analyses excluded the Swedish audit because < 100 MIPD were performed during the studied period. RESULTS: Overall, 44,076 patients who underwent pancreatoduodenectomy were included (29,107 North America, 7586 Germany, 4970 the Netherlands, and 2413 Sweden), including 3328 MIPD procedures (8%). The use of MIPD varied widely among countries (absolute largest difference [ALD] 17%, p < 0.001): 7% North America, 4% Germany, 17% the Netherlands, and 0.1% Sweden. Over time, the use of MIPD increased in North America and the Netherlands (p < 0.001), mostly driven by robotic MIPD, but not in Germany (p = 0.297). Patient factors predicting the use of MIPD included country, later year of operation, better performance status, high POPF-risk score, no vascular resection, and non-malignant indication. Conversion rates were higher in laparoscopic MIPD (range 28-45%), compared to robotic MIPD (range 9-37%). In-hospital/30-day mortality differed among North America, Germany, and the Netherlands; MIPD (2%, 7%, 4%; ALD 5%, p < 0.001) and OPD (2%, 5%, 3%; ALD 3%, p < 0.001), similar to major morbidity; MIPD (25%, 42%, 38%, ALD 17%, p < 0.001) and OPD (25%, 31%, 30%, ALD 6%, p < 0.001), respectively. CONCLUSIONS: Considerable differences were found in the use and outcome, including conversion and mortality rates, of MIPD and OPD among four transatlantic audits for pancreatic surgery. Our findings highlight the need for international collaboration to optimize treatment standards and patient outcome.

3.
Ann Surg ; 278(5): 655-661, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37465982

RESUMO

INTRODUCTION: Over the past 2 decades, physicians' wellbeing has become a topic of interest. It is currently unclear what the current needs are of early career academic surgeons (ECAS). METHODS: Consensus statements on academic needs were developed during a Delphi process, including all presenters from the previous European Surgical Association (ESA) meetings (2018-2022). The Delphi involved (1) a literature review, (2) Delphi form generation, and (3) an accelerated Delphi process. The Delphi form was generated by a steering group that discussed findings identified within the literature. The modified accelerated e-consensus approach included 3 rounds over a 4-week period. Consensus was defined as >80% agreement in any round. RESULTS: Forty respondents completed all 3 rounds of the Delphi. Median age was 37 years (interquartile range 5), and 53% were female. Majority were consultant/attending (52.5%), followed by PhD (22.5%), fellowship (15%), and residency (10%). ECAS was defined as a surgeon in 'development' years of clinical and academic practice relative to their career goals (87.9% agreement). Access to split academic and clinical contracts is desirable (87.5%). Consensus on the factors contributing to ECAS underperformance included: burnout (94.6%), lack of funding (80%), lack of mentorship (80%), and excessive clinical commitments (80%). Desirable factors to support ECAS development included: access to e-learning (90.9%), face-to-face networking opportunities (95%), support for research team development (100%), and specific formal mentorship (93.9%). CONCLUSION: The evolving role and responsibilities of ECAS require increasing strategic support, mentorship, and guidance on structured career planning. This will facilitate workforce sustainability in academic surgery in the future.


Assuntos
Internato e Residência , Cirurgiões , Humanos , Feminino , Adulto , Masculino , Avaliação das Necessidades , Consenso , Técnica Delphi
4.
Ann Surg ; 278(5): 740-747, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37476990

RESUMO

OBJECTIVE: The aim of this study is to define and assess Ideal Outcome in the national or multicenter registries of North America, Germany, the Netherlands, and Sweden. BACKGROUND: Assessing outcomes after pancreatoduodenectomy among centers and countries requires a broad evaluation that cannot be captured by a single parameter. Previously, 2 composite outcome measures (textbook outcome and optimal pancreatic surgery) for pancreatoduodenectomy have been described from Europe and the United States. These composites were harmonized into ideal outcome (IO). METHODS: This analysis is a transatlantic retrospective study (2018-2020) of patients after pancreatoduodenectomy within the registries from North America, Germany, The Netherlands, and Sweden. After 3 consensus meetings, IO for pancreatoduodenectomy was defined as the absence of all 6 parameters: (1) in-hospital mortality, (2) severe complications-Clavien-Dindo ≥3, (3) postoperative pancreatic fistula-International Study Group of Pancreatic Surgery (ISGPS) grade B/C, (4) reoperation, (5) hospital stay >75th percentile, and (6) readmission. Outcomes were evaluated using relative largest difference (RLD) and absolute largest difference (ALD), and multivariate regression models. RESULTS: Overall, 21,036 patients after pancreatoduodenectomy were included, of whom 11,194 (54%) reached IO. The rate of IO varied between 55% in North America, 53% in Germany, 52% in The Netherlands, and 54% in Sweden (RLD: 1.1, ALD: 3%, P <0.001). Individual components varied with an ALD of 2% length of stay, 4% for in-hospital mortality, 12% severe complications, 10% postoperative pancreatic fistula, 11% reoperation, and 9% readmission. Age, sex, absence of chronic obstructive pulmonary disease, body mass index, performance status, American Society of Anesthesiologists (ASA) score, biliary drainage, absence of vascular resection, and histologic diagnosis were associated with IO. In the subgroup of patients with pancreatic adenocarcinoma, country, and neoadjuvant chemotherapy also was associated with improved IO. CONCLUSIONS: The newly developed composite outcome measure "Ideal Outcome" can be used for auditing and comparing outcomes after pancreatoduodenectomy. The observed differences can be used to guide collaborative initiatives to further improve the outcomes of pancreatic surgery.


Assuntos
Adenocarcinoma , Neoplasias Pancreáticas , Humanos , Pancreaticoduodenectomia , Fístula Pancreática/epidemiologia , Fístula Pancreática/etiologia , Estudos Retrospectivos , Neoplasias Pancreáticas/cirurgia , Adenocarcinoma/cirurgia , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias
5.
Ann Surg ; 277(6): e1299-e1305, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35786606

RESUMO

OBJECTIVE: The aim of this study was to assess the clinical impact and risk factors of chyle leak (CL). BACKGROUND: In 2017, the International Study Group for Pancreatic Surgery (ISGPS) published the consensus definition of CL. Multicenter series validating this definition are lacking and previous studies investigating risk factors have used different definitions and showed heterogeneous results. METHODS: This observational cohort study included all consecutive patients after pancreatoduodenectomy in all 19 centers in the mandatory nationwide Dutch Pancreatic Cancer Audit (2017-2019). The primary endpoint was CL (ISGPS grade B/C). Multivariable logistic regression analyses were performed. RESULTS: Overall, 2159 patients after pancreatoduodenectomy were included. The rate of CL was 7.0% (n=152), including 6.9% (n=150) grade B and 0.1% (n=2) grade C. CL was independently associated with a prolonged hospital stay [odds ratio (OR)=2.84, 95% confidence interval (CI): 1.85-4.36, P <0.001] but not with mortality (OR=0.3, 95% CI: 0.0-2.3, P =0.244). In multivariable analyses, independent predictors for CL were vascular resection (OR=2.1, 95% CI: 1.4-3.2, P <0.001) and open surgery (OR=3.5, 95% CI: 1.7-7.2, P =0.001). The number of resected lymph nodes and aortocaval lymph node sampling were not identified as predictors in multivariable analysis. CONCLUSIONS: In this nationwide analysis, the rate of ISGPS grade B/C CL after pancreatoduodenectomy was 7.0%. Although CL is associated with a prolonged hospital stay, the clinical impact is relatively minor in the vast majority (>98%) of patients. Vascular resection and open surgery are predictors of CL.


Assuntos
Quilo , Neoplasias Pancreáticas , Humanos , Pancreaticoduodenectomia/efeitos adversos , Pancreaticoduodenectomia/métodos , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Neoplasias Pancreáticas/cirurgia
6.
Ann Surg ; 278(6): e1232-e1241, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-37288547

RESUMO

OBJECTIVE: To assess the feasibility, proficiency, and mastery learning curves for robotic pancreatoduodenectomy (RPD) in "second-generation" RPD centers following a multicenter training program adhering to the IDEAL framework. BACKGROUND: The long learning curves for RPD reported from "pioneering" expert centers may discourage centers interested in starting an RPD program. However, the feasibility, proficiency, and mastery learning curves may be shorter in "second-generation" centers that participated in dedicated RPD training programs, although data are lacking. We report on the learning curves for RPD in "second-generation" centers trained in a dedicated nationwide program. METHODS: Post hoc analysis of all consecutive patients undergoing RPD in 7 centers that participated in the LAELAPS-3 training program, each with a minimum annual volume of 50 pancreatoduodenectomies, using the mandatory Dutch Pancreatic Cancer Audit (March 2016-December 2021). Cumulative sum analysis determined cutoffs for the 3 learning curves: operative time for the feasibility (1) risk-adjusted major complication (Clavien-Dindo grade ≥III) for the proficiency, (2) and textbook outcome for the mastery, (3) learning curve. Outcomes before and after the cutoffs were compared for the proficiency and mastery learning curves. A survey was used to assess changes in practice and the most valued "lessons learned." RESULTS: Overall, 635 RPD were performed by 17 trained surgeons, with a conversion rate of 6.6% (n=42). The median annual volume of RPD per center was 22.5±6.8. From 2016 to 2021, the nationwide annual use of RPD increased from 0% to 23% whereas the use of laparoscopic pancreatoduodenectomy decreased from 15% to 0%. The rate of major complications was 36.9% (n=234), surgical site infection 6.3% (n=40), postoperative pancreatic fistula (grade B/C) 26.9% (n=171), and 30-day/in-hospital mortality 3.5% (n=22). Cutoffs for the feasibility, proficiency, and mastery learning curves were reached at 15, 62, and 84 RPD. Major morbidity and 30-day/in-hospital mortality did not differ significantly before and after the cutoffs for the proficiency and mastery learning curves. Previous experience in laparoscopic pancreatoduodenectomy shortened the feasibility (-12 RPDs, -44%), proficiency (-32 RPDs, -34%), and mastery phase learning curve (-34 RPDs, -23%), but did not improve clinical outcome. CONCLUSIONS: The feasibility, proficiency, and mastery learning curves for RPD at 15, 62, and 84 procedures in "second-generation" centers after a multicenter training program were considerably shorter than previously reported from "pioneering" expert centers. The learning curve cutoffs and prior laparoscopic experience did not impact major morbidity and mortality. These findings demonstrate the safety and value of a nationwide training program for RPD in centers with sufficient volume.


Assuntos
Laparoscopia , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Pancreaticoduodenectomia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Curva de Aprendizado , Estudos de Viabilidade , Laparoscopia/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia
7.
Oncologist ; 28(11): 961-968, 2023 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-37589234

RESUMO

BACKGROUND: Due to increased use of imaging, advanced stages of cancer are increasingly being diagnosed in an early, asymptomatic phase. Traditionally, chemotherapy is started immediately in these patients. However, a strategy wherein chemotherapy is withheld until symptoms occur may be beneficial for patients in terms of quality of life (QOL). A systematic review regarding optimal timing of chemotherapy including survival and QOL is lacking. METHODS: We systematically searched PubMed, EMBASE, and Cochrane for studies investigating the timing of start of chemotherapy in asymptomatic patients with advanced cancer. Overall survival (OS) was abstracted as primary, QOL, and toxicity as secondary outcomes. A meta-analysis was performed on OS. QOL was described using the global health status derived from the EORTC-QLQ-C30 questionnaire and toxicity as grade 3-4 adverse events. RESULTS: Overall, 919 patients from 4 randomized controlled trials and 1 retrospective study were included. The included studies investigated colorectal cancer (n = 3), ovarian cancer (n = 1), and gastric cancer (n = 1). Pooled analysis demonstrated no significant differences in OS between delayed and immediate start of chemotherapy (pooled HR: 1.05, 95% CI, 0.90-1.22, P = .52). QOL, evaluated in 3 studies, suggested a better QOL in the delayed treatment group. Toxicity, evaluated in 2 studies, did not differ significantly between groups. CONCLUSION: This meta-analysis confirms the need for prospective studies on timing of start of chemotherapy in asymptomatic patients with advanced cancer. The limited evidence available suggests that delayed start of chemotherapy, once symptoms occur, as compared to immediate start in asymptomatic patients does not worsen OS while it may preserve QOL.


Assuntos
Neoplasias Ovarianas , Neoplasias Gástricas , Feminino , Humanos , Qualidade de Vida , Estudos Prospectivos , Estudos Retrospectivos
8.
Ann Surg Oncol ; 30(8): 5051-5060, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37210448

RESUMO

BACKGROUND: Surgeons aim for R0 resection in patients with pancreatic cancer to improve overall survival. However, it is unclear whether recent changes in pancreatic cancer care such as centralization, increased use of neoadjuvant therapy, minimally invasive surgery, and standardized pathology reporting have influenced R0 resections and whether R0 resection remains associated with overall survival. METHODS: This nationwide retrospective cohort study included consecutive patients after pancreatoduodenectomy (PD) for pancreatic cancer from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Database (2009-2019). R0 resection was defined as > 1 mm tumor clearance at the pancreatic, posterior, and vascular resection margins. Completeness of pathology reporting was scored on the basis of six elements: histological diagnosis, tumor origin, radicality, tumor size, extent of invasion, and lymph node examination. RESULTS: Among 2955 patients after PD for pancreatic cancer, the R0 resection rate was 49%. The R0 resection rate decreased from 68 to 43% (2009-2019, P < 0.001). The extent of resections in high-volume hospitals, minimally invasive surgery, neoadjuvant therapy, and complete pathology reports all significantly increased over time. Only complete pathology reporting was independently associated with lower R0 rates (OR 0.76, 95% CI 0.69-0.83, P < 0.001). Higher hospital volume, neoadjuvant therapy, and minimally invasive surgery were not associated with R0. R0 resection remained independently associated with improved overall survival (HR 0.72, 95% CI 0.66-0.79, P < 0.001), as well as in the 214 patients after neoadjuvant treatment (HR 0.61, 95% CI 0.42-0.87, P = 0.007). CONCLUSIONS: The nationwide rate of R0 resections after PD for pancreatic cancer decreased over time, mostly related to more complete pathology reporting. R0 resection remained associated with overall survival.


Assuntos
Neoplasias Pancreáticas , Pancreaticoduodenectomia , Humanos , Terapia Neoadjuvante , Estudos Retrospectivos , Neoplasias Pancreáticas/patologia , Procedimentos Cirúrgicos Minimamente Invasivos , Neoplasias Pancreáticas
9.
Ann Surg ; 276(5): 753-760, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-35866665

RESUMO

INTRODUCTION: Randomized controlled trials (RCTs) yield the highest level of evidence but are notoriously difficult to perform in surgery. Surgical RCTs may be hampered by slow accrual, the surgical learning curve, and lack of financial support. Alternative RCT designs such as stepped-wedge randomized controlled trials (SW-RCTs), registry-based randomized controlled trials (RB-RCTs), and trials-within-cohorts (TwiCs) may overcome several of these difficulties. This review provides an overview of alternative RCT designs used in surgical research. METHODS: We systematically searched PubMed, EMBASE, and Cochrane Central for surgical SW-RCTs, RB-RCTs, and TwiCs. A surgical RCT was defined as a randomized trial that studied interventions in patients undergoing general surgery, regardless of the affiliation of the corresponding author. Exponential regression analysis was performed to assess time trends. RESULTS: Overall, 41 surgical RCTs using alternative designs were identified, including 17 published final RCT reports and 24 published protocols of ongoing RCTs. These included 25 SW-RCTs (61%), 13 RB-RCTs (32%), and 3 TwiCs (7%). Most of these RCTs were performed in Europe (63%) and within gastrointestinal/oncological surgery (41%). The total number of RCTs using alternative designs exponentially increased over the last 7 years ( P <0.01), with 95% (n=39/41) of the total number published within this time frame. The most reported reasons for using alternative RCT designs were avoidance of contamination for SW-RCTs and generalizability of the trial population for RB-RCTs and TwiCs. CONCLUSIONS: Alternative RCT designs are increasingly used in surgical research, mostly in Europe and within gastrointestinal/oncological surgery. When adequately used, these alternative designs may overcome several difficulties associated with surgical RCTs.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Europa (Continente) , Humanos
10.
Support Care Cancer ; 30(6): 4879-4887, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35169873

RESUMO

PURPOSE: It is plausible that patients with pancreatic cancer experience fear of tumor recurrence or progression (FOP). The aim of this study was to compare FOP in patients with pancreatic cancer treated with surgical resection, palliative systemic treatment, or best supportive care (BSC) and analyze the association between quality of life (QoL) and FOP and the effect of FOP on overall survival (OS). METHODS: This study included patients diagnosed with pancreatic cancer between 2015 and 2018, who participated in the Dutch Pancreatic Cancer Project (PACAP). The association between QoL and WOPS was assessed with logistic regression analyses. OS was evaluated using Kaplan-Meier curves with the log-rank tests and multivariable Cox proportional hazard analyses adjusted for clinical covariates and QoL. RESULTS: Of 315 included patients, 111 patients underwent surgical resection, 138 received palliative systemic treatment, and 66 received BSC. Patients who underwent surgical resection had significantly lower WOPS scores (i.e., less FOP) at initial diagnosis compared to patients who received palliative systemic treatment or BSC only (P < 0.001). Better QoL was independently associated with the probability of having a low FOP in the BSC (OR 0.95, 95% CI 0.91-0.98) but not in the surgical resection (OR 0.97, 95% CI 0.94-1.01) and palliative systemic treatment groups (OR 0.97, 95% CI 0.94-1.00). The baseline WOPS score was not independently associated with OS in any of the subgroups. CONCLUSION: Given the distress that FOP evokes, FOP should be explicitly addressed by health care providers when guiding pancreatic cancer patients through their treatment trajectory, especially those receiving palliative treatment or BSC.


Assuntos
Neoplasias Pancreáticas , Qualidade de Vida , Medo , Humanos , Neoplasias Pancreáticas/cirurgia , Transtornos Fóbicos , Neoplasias Pancreáticas
14.
J Am Coll Surg ; 238(4): 613-621, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38224148

RESUMO

BACKGROUND: The introduction of modern chemotherapy a decade ago has led to increased use of neoadjuvant therapy (NAT) in patients with pancreatic ductal adenocarcinoma (PDAC). A recent North American study demonstrated increased use of NAT and improved operative outcomes in patients with PDAC. The aims of this study were to compare the use of NAT and short-term outcomes in patients with PDAC undergoing pancreatoduodenectomy (PD) among registries from the US and Canada, Germany, the Netherlands, and Sweden. STUDY DESIGN: Databases from 2 multicenter (voluntary) and 2 nationwide (mandatory) registries were queried from 2018 to 2020. Patients undergoing PD for PDAC were compared based on the use of upfront surgery vs NAT. Adoption of NAT was measured in each country over time. Thirty-day outcomes, including the composite measure (ideal outcomes), were compared by multivariable analyses. Sensitivity analyses of patients undergoing vascular resection were performed. RESULTS: Overall, 11,402 patients underwent PD for PDAC with 33.7% of patients receiving NAT. The use of NAT increased steadily from 28.3% in 2018 to 38.5% in 2020 (p < 0.0001). However, use of NAT varied widely by country: the US (46.8%), the Netherlands (44.9%), Sweden (11.0%), and Germany (7.8%). On multivariable analysis, NAT was significantly (p < 0.01) associated with reduced rates of serious morbidity, clinically relevant pancreatic fistulae, reoperations, and increased ideal outcomes. These associations remained on sensitivity analysis of patients undergoing vascular resection. CONCLUSIONS: NAT before PD for pancreatic cancer varied widely among 4 Western audits yet increased by 26% during 3 years. NAT was associated with improved short-term outcomes.


Assuntos
Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Humanos , Carcinoma Ductal Pancreático/cirurgia , Carcinoma Ductal Pancreático/tratamento farmacológico , Terapia Neoadjuvante , Pancreatectomia , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/tratamento farmacológico , Pancreaticoduodenectomia , Estudos Retrospectivos , Estudos Multicêntricos como Assunto
15.
Clin Transl Gastroenterol ; 15(9): e1, 2024 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-39320960

RESUMO

INTRODUCTION: Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. METHODS: Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant. RESULTS: Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life. DISCUSSION: Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.


Assuntos
Anestésicos Locais , Carcinoma Ductal Pancreático , Lidocaína , Medição da Dor , Dor Intratável , Neoplasias Pancreáticas , Pancreatite Crônica , Humanos , Projetos Piloto , Lidocaína/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , Pancreatite Crônica/complicações , Pancreatite Crônica/tratamento farmacológico , Estudos Prospectivos , Carcinoma Ductal Pancreático/tratamento farmacológico , Carcinoma Ductal Pancreático/complicações , Neoplasias Pancreáticas/complicações , Neoplasias Pancreáticas/tratamento farmacológico , Idoso , Anestésicos Locais/administração & dosagem , Infusões Intravenosas , Dor Intratável/tratamento farmacológico , Dor Intratável/etiologia , Resultado do Tratamento , Adulto , Países Baixos
16.
Artigo em Inglês | MEDLINE | ID: mdl-39163321

RESUMO

INTRODUCTION: Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. METHODS: Multicentre prospective non-randomized pilot study including patients with moderate or severe pain (NRS ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5mg/kg, was followed by continuous infusion at 1.5 mg/kg/hour. The dose was raised every 15 minutes until treatment response (up to a maximum 2mg/kg/hour) and consecutively administered for two hours. Primary outcome was the mean difference in pain severity, pre-infusion and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥ 1.3 points was considered clinically relevant. RESULTS: Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day one was 1.1 (SD±1.3) points for patients with PDAC and 0.5 (SD±1.7) for CP patients. A clinically relevant decrease in BPI on day one was reported in 9/29 patients (31%), this response lasted up to one month. No serious complications were reported, and only three minor complications (vertigo, nausea, tingling of mouth). Treatment with lidocaine did not impact quality of life. CONCLUSION: Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group, and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

17.
Surgery ; 176(4): 1198-1206, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39019733

RESUMO

BACKGROUND: The efficacy and safety of minimally invasive distal pancreatectomy have been confirmed by randomized trials, but current patient selection and outcome of minimally invasive distal pancreatectomy in large international cohorts is unknown. This study aimed to compare the use and outcome of minimally invasive distal pancreatectomy in North America, the Netherlands, Germany, and Sweden. METHODS: All patients in the 4 Global Audits on Pancreatic Surgery Group (GAPASURG) registries who underwent minimally invasive distal pancreatectomy or open distal pancreatectomy during 2014-2020 were included. RESULTS: Overall, 20,158 distal pancreatectomies were included, of which 7,316 (36%) were minimally invasive distal pancreatectomies. Use of minimally invasive distal pancreatectomy varied from 29% to 54% among registries, of which 13% to 35% were performed robotically. Both the use of minimally invasive distal pancreatectomy and robotic surgery were the highest in the Netherlands. Patients undergoing minimally invasive distal pancreatectomy tended to have a younger age (Germany and Sweden), female sex (North America, Germany), higher body mass index (North America, the Netherlands, Germany), lower comorbidity classification (North America, Germany, Sweden), lower performance status (Germany), and lower rate of pancreatic adenocarcinoma (all). The minimally invasive distal pancreatectomy group had fewer vascular resections (all) and lower rates of severe complications and mortality (North America, Germany). In the multivariable regression analysis, country was associated with severe complications but not with 30-day mortality. Minimally invasive distal pancreatectomy was associated with a lower risk of 30-day mortality compared with open distal pancreatectomy (odds ratio 1.633, 95% CI 1.159-2.300, P = .005). CONCLUSIONS: Considerable disparities were seen in the use of minimally invasive distal pancreatectomy among 4 transatlantic registries of pancreatic surgery. Overall, minimally invasive distal pancreatectomy was associated with decreased mortality as compared with open distal pancreatectomy. Differences in patient selection among countries could imply that countries are in different stages of the learning curve.


Assuntos
Procedimentos Cirúrgicos Minimamente Invasivos , Pancreatectomia , Neoplasias Pancreáticas , Seleção de Pacientes , Sistema de Registros , Procedimentos Cirúrgicos Robóticos , Humanos , Pancreatectomia/métodos , Pancreatectomia/estatística & dados numéricos , Pancreatectomia/efeitos adversos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/mortalidade , Suécia/epidemiologia , Países Baixos/epidemiologia , Resultado do Tratamento , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Adulto , Alemanha/epidemiologia , América do Norte/epidemiologia
18.
JAMA Surg ; 159(4): 429-437, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38353966

RESUMO

Importance: Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal. Objective: To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival. Design, setting, and participants: This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients). Intervention: The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care. Main Outcomes and Measures: The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score). Results: Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94). Conclusions and Relevance: In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options. Trial Registration: ClinicalTrials.gov Identifier: NCT03513705.


Assuntos
Gencitabina , Neoplasias Pancreáticas , Humanos , Feminino , Idoso , Masculino , Desoxicitidina , Países Baixos , Qualidade de Vida , Neoplasias Pancreáticas/tratamento farmacológico
19.
Eur J Trauma Emerg Surg ; 49(3): 1247-1258, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36512031

RESUMO

PURPOSE: Anemia is one of the most common complications after hip fracture surgery. Tranexamic acid (TXA) has been considered effective in preventing anemia in total hip arthroplasty, but its role in hemiarthroplasty is debated. The aim of this systematic review was to investigate the efficacy and safety of perioperative TXA for hip hemiarthroplasty. METHODS: A systematic literature search was performed to identify studies comparing adult patients who underwent hemiarthroplasty for a hip fracture with and without perioperative TXA. The primary outcome was transfusion rate. Secondary outcomes included postoperative hemoglobin, length of hospital stay, adverse events (i.e., deep venous thromboses and pulmonary embolism), and 30-day mortality. RESULTS: In total, 13 articles were included, comprising 54,843 patients of whom 14.1% received perioperative TXA. TXA was applied intravenous in ten studies, topical in two studies, one study investigated both. Pooled results showed a significant reduction in transfusion rate (pooled RR: 0.48, 95% CI 0.40-0.58, p < 0.01). Postoperative hemoglobin and length of stay were investigated in nine studies, pooled results showed significant improvement of both outcomes for patients that received TXA. Eleven studies investigated thromboembolic events, and there was no statistical difference in deep venous thromboses (pooled RR: 0.67, 95% CI 0.18-2.56, p = 0.56) or pulmonary embolism (pooled RR: 1.10, 95% CI 0.45-2.68, p = 0.83) among the two groups. There was a significant reduction in 30-day mortality for patients that received TXA. CONCLUSION: TXA can be considered effective and safe for patients undergoing hip hemiarthroplasty, with a reduction in transfusion rate and increase in postoperative hemoglobin, without increasing adverse events. Optimal timing, dosage, and type of administration of TXA remain unclear.


Assuntos
Anemia , Antifibrinolíticos , Artroplastia de Quadril , Hemiartroplastia , Fraturas do Quadril , Embolia Pulmonar , Ácido Tranexâmico , Trombose Venosa , Adulto , Humanos , Antifibrinolíticos/efeitos adversos , Hemiartroplastia/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/etiologia , Hemoglobinas , Anemia/complicações , Anemia/cirurgia , Fraturas do Quadril/cirurgia , Fraturas do Quadril/complicações , Artroplastia de Quadril/efeitos adversos , Trombose Venosa/prevenção & controle , Trombose Venosa/etiologia
20.
Cureus ; 15(4): e37318, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37181957

RESUMO

Introduction To provide high-quality surgical care, surgeons must critically appraise medical literature to adapt their clinical practice whenever convincing evidence emerges. This will promote evidence-based surgery (EBS). Over the last decade, we have organized monthly journal clubs (JCs) and more extensive quarterly EBS courses for surgical residents and PhD students, supervised by surgical staff. We evaluated the participation, satisfaction, and knowledge gained by this EBS program, to make the program future-proof and aid other educators. Materials and methods An anonymous digital survey was distributed via email among residents, PhD students, and surgeons of the Amsterdam University Medical Centers' (UMC) surgical department in April 2022. The survey included general questions on EBS education, specific course-oriented questions for the residents and PhD students, and questions about supervision for surgeons. Results The survey was completed by 47 respondents from the surgery department of the Amsterdam UMC University Hospital, of whom 63.8% (n=30) were residents or PhD students and 36.2% (n=17) were surgeons. During one year of the combined EBS course and JCs, the EBS course was attended by 40.0% (n=12) of PhD students and was rated with a mean score of 7.6/10. JCs were attended by 86.6% (n=26) of residents or PhD students and received a mean score of 7.4/10. Reported strengths of the JCs were their easy accessibility and the acquisition of critical appraisal skills and scientific knowledge. A reported point of improvement was to focus more deeply on specific epidemiological topics per meeting. Of the surgeons, 64.7% (n=11) had supervised at least one JC and gave a mean score of 8.5/10. The main reasons to supervise JCs were the distribution of knowledge (45.5%), scientific discussion (36.3%), and contact with PhD students (18.1%). Conclusion Our EBS educational program, including JCs and EBS courses, was well appreciated by residents, PhD students, and staff. This format is advocated for other centers aiming to better implement EBS in surgical practice.

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