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Importance: The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year. Objective: To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up. Design, Setting, and Participants: This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023. Interventions: Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy. Main Outcomes and Measures: The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction. Results: Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction. Conclusions and Relevance: In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes. Trial Registration: CCMO Identifier: NTR4022.
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BACKGROUND: A textbook outcome for the management of uncomplicated cholecystolithiasis is the targeted clinical scenario and is characterized by no recurrent biliary colic, absence of surgical and biliary complications, and absence or relief of abdominal pain. The aim of this study was to assess the incidence of textbook outcomes after cholecystectomy and identify associated baseline factors. METHODS: Patients from 2 Dutch multicenter prospective trials between 2014 and 2019 (SECURE and SUCCESS trial) were included. The primary outcome was the proportion of patients with textbook outcomes after cholecystectomy at 6-month follow-up. Regression analysis was used to identify which factors before surgery were associated with textbook outcomes. RESULTS: A total of 1,124 patients underwent cholecystectomy. A textbook outcome at 6-month follow-up was reached in 67.9% of patients. Persistent abdominal pain was the main reason for the failure to achieve textbook outcome. Patients who did achieve textbook outcomes more often reported severe pain attacks (89.4% vs 81.7%, P < .001) and/or biliary colic (78.6% vs 68.4%, P < .001) at baseline compared with patients without textbook outcomes. The presence of biliary colic at baseline (odds ratio = 1.56, 95% confidence interval: 1.16-2.09, P = .003) and nausea/vomiting at baseline (odds ratio = 1.33, 95% confidence interval: 1.01-1.74, P = .039) were associated with textbook outcome. The use of non-opioid analgesics (odds ratio = 0.76, 95% confidence interval: 0.58-0.99, P = .043) and pain frequency ≥1/month (odds ratio = 0.56, 95% confidence interval: 0.43-0.73, P < .001) were negatively associated with textbook outcome. CONCLUSION: Textbook outcome is achieved in two-thirds of patients who undergo cholecystectomy for uncomplicated cholecystolithiasis. Intensity and frequency of pain, presence of biliary colic, and nausea/vomiting at baseline are independently associated with achieving textbook outcomes. A more stringent selection of patients may optimize the textbook outcome rate in patients with uncomplicated cholecystolithiasis.
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Colecistectomía , Colecistolitiasis , Humanos , Femenino , Masculino , Colecistolitiasis/cirugía , Colecistolitiasis/complicaciones , Persona de Mediana Edad , Adulto , Anciano , Resultado del Tratamiento , Colecistectomía/efectos adversos , Estudios Prospectivos , Cólico/cirugía , Cólico/etiología , Dolor Abdominal/etiología , Dolor Abdominal/epidemiología , Países Bajos/epidemiología , Estudios de SeguimientoRESUMEN
Prehabilitation is an upcoming strategy to optimize patient's functional capacity, nutritional status, and psychosocial well-being in order to reduce surgical complications and enhance recovery. This study aims to assess the feasibility of implementing a multimodal prehabilitation program into the standard care of gynecological oncology patients at an academic hospital in terms of recruitment, adherence, and safety, which were assessed by the number of patients eligible, recruitment rate, participation rate, and adherence to individual modalities. Data were derived from the F4S PREHAB trial, a single-center stepped-wedge trial implementing a multimodal prehabilitation program among various surgical specialties. All patients undergoing elective surgery as part of treatment for ovarian, uterine, and vulvar cancer at the Radboudumc, an academic hospital in The Netherlands, between May 2022 and September 2023 were considered eligible for the F4S PREHAB trial and, consequently, were included in this cohort study. The multimodal prehabilitation program comprised a physical exercise intervention, nutritional intervention, psychological intervention, and an intoxication cessation program. A total of 152 patients were eligible and approached for participation of which 111 consented to participate, resulting in a recruitment rate of 73%. Participants attended an average of six exercise sessions and adhered to 85% of possible training sessions. Respectively, 93% and 98% of participants adhered to the prescribed daily protein and vitamin suppletion. Ten participants were referred to a psychologist and completed consultations. Out of nine active smokers, two managed to quit smoking. A total of 59% adhered to alcohol cessation advice. No adverse events were reported. This study demonstrates that introducing a multimodal prehabilitation program into the standard care of gynecological oncology patients is feasible in terms of recruitment and adherence, with no serious adverse events.
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This study evaluated the relationship between apparent diffusion coefficient (ADC) values in pancreatic ductal adenocarcinoma (PDAC) and tumor grades based on WHO, Adsay, and Kalimuthu classifications, using whole-mount pancreatectomy specimens. If glandular formation plays a key role in the degree of diffusion restriction, diffusion-weighted imaging could facilitate non-invasive grading of PDAC. A freehand region of interest (ROI) was drawn along tumor borders on the preoperative ADC map in each tumor-containing slice. Resection specimens were retrospectively graded according to WHO, Adsay, and Kalimuthu classifications and correlated with overall survival and the 10th percentile of whole-volume ADC values. Findings from 40 patients (23 male, median age 67) showed no correlation between ADC p10 values and WHO differentiation (p = 0.050), Adsay grade (p = 0.955), or Kalimuthu patterns (p = 0.117). There was no association between ADC p10 and overall survival (p = 0.082) and other clinicopathological variables. Survival was significantly lower for poor tumor differentiation (p = 0.046) and non-glandular Kalimuthu patterns (p = 0.016) and there was a trend towards inferior survival for Adsay G3 (p = 0.090) after correction for age, tumor location, and stage. Preoperative ADC measurements for determining PDAC aggressiveness had limited clinical utility, as there was no correlation with histological parameters or overall survival in resectable PDAC.
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BACKGROUND: Laparoscopic cholecystectomy is the gold standard for treating biliary colic in patients with gallstones, but post-cholecystectomy abdominal pain is commonly reported. This study investigates which symptoms are likely to persist and which may develop after a cholecystectomy. METHODS: Patients from 2 previous prospective trials who underwent laparoscopic cholecystectomy for symptomatic cholecystolithiasis were included. Patients completed questionnaires on pain and gastrointestinal symptoms before surgery and at 6 months follow-up. The prevalence of persistent and new-onset abdominal symptoms was evaluated. RESULTS: A total of 820 patients received cholecystectomy and were included, 75.4% female (n = 616/820) mean age 49.4 years (standard deviation 13.7). At baseline, 74.1% (n = 608/820) of patients met all criteria for biliary colic. Cholecystectomy successfully resolved biliary colic in 94.8% (n = 327/345) of patients, but 36.5% (n = 299/820) of patients reported persistent abdominal pain after 6 months of follow-up. The prevalence of most abdominal symptoms reduced significantly. Symptoms such as flatulence (17.8%, n = 146/820) or restricted eating (14.5%, n = 119/820) persisted most often. New-onset symptoms were frequent bowel movements (9.6%, n = 79/820), bowel urgency (8.5%, n = 70/820), and new-onset diarrhea (8.4%, 69/820). CONCLUSION: Postcholecystectomy symptoms are mainly flatulence, frequent bowel movements, and restricted eating. Newly reported symptoms are mainly frequent bowel movements, bowel urgency, and diarrhea. The present findings give clinical guidance in informing, managing, and treating patients with symptoms after cholecystectomy.
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Enfermedades de los Conductos Biliares , Colecistectomía Laparoscópica , Colecistolitiasis , Cólico , Enfermedades de la Vesícula Biliar , Humanos , Femenino , Persona de Mediana Edad , Masculino , Cólico/epidemiología , Cólico/etiología , Cólico/cirugía , Colecistolitiasis/complicaciones , Colecistolitiasis/cirugía , Flatulencia/complicaciones , Flatulencia/cirugía , Estudios Prospectivos , Colecistectomía/efectos adversos , Dolor Abdominal/diagnóstico , Dolor Abdominal/epidemiología , Dolor Abdominal/etiología , Colecistectomía Laparoscópica/efectos adversos , Enfermedades de la Vesícula Biliar/cirugía , Diarrea/etiología , Enfermedades de los Conductos Biliares/cirugíaRESUMEN
This study aimed to quantify the confirmation of gallstones on ultrasound (US) in patients with suspicion of gallstone disease. To aid general practitioners (GPs) in diagnostic workup, a model to predict gallstones was developed. A prospective cohort study was conducted in two Dutch general hospitals. Patients (≥18 years) were eligible for inclusion when referred by GPs for US with suspicion of gallstones. The primary outcome was the confirmation of gallstones on US. A multivariable regression model was developed to predict the presence of gallstones. In total, 177 patients were referred with a clinical suspicion of gallstones. Gallstones were found in 64 of 177 patients (36.2%). Patients with gallstones reported higher pain scores (VAS 8.0 vs. 6.0, p < 0.001), less frequent pain (21.9% vs. 54.9%, p < 0.001), and more often met criteria for biliary colic (62.5% vs. 44.2%, p = 0.023). Predictors for the presence of gallstones were a higher pain score, frequency of pain less than weekly, biliary colic, and an absence of heartburn. The model showed good discrimination between patients with and without gallstones (C-statistic 0.73, range: 0.68-0.76). Clinical diagnosis of symptomatic gallstone disease is challenging. The model developed in this study may aid in the selection of patients for referral and improve treatment related outcomes.
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BACKGROUND: International consensus on the ideal outcome for treatment of uncomplicated symptomatic gallstone disease is absent. This mixed-method study defined a Textbook Outcome (TO) for this large group of patients. METHODS: First, expert meetings were organised with stakeholders to design the survey and identify possible outcomes. To reach consensus, results from expert meetings were converted in a survey for clinicians and for patients. During the final expert meeting, clinicians and patients discussed survey outcomes and a definitive TO was formulated. Subsequently, TO-rate and hospital variation were analysed in Dutch hospital data from patients with uncomplicated gallstone disease. RESULTS: First expert meetings returned 32 outcomes. Outcomes were distributed in a survey among 830 clinicians from 81 countries and 645 Dutch patients. Consensus-based TO was defined as no more biliary colic, no biliary and surgical complications, and the absence or reduction of abdominal pain. Analysis of individual patient data showed that TO was achieved in 64.2% (1002/1561). Adjusted-TO rates showed modest variation between hospitals (56.6-74.9%). CONCLUSION: TO for treatment of uncomplicated gallstone disease was defined as no more biliary colic, no biliary and surgical complications, and absence or reduction of abdominal pain.TO may optimise consistent outcome reporting in care and guidelines for treating uncomplicated gallstone disease.
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Colecistectomía Laparoscópica , Cólico , Enfermedades de la Vesícula Biliar , Cálculos Biliares , Humanos , Cálculos Biliares/diagnóstico , Cálculos Biliares/cirugía , Colecistectomía/efectos adversos , Colecistectomía Laparoscópica/efectos adversos , Dolor Abdominal , Enfermedades de la Vesícula Biliar/cirugíaRESUMEN
Introduction: The aim of this study was to review the effect of irreversible electroporation parameter settings on the size of the ablation zone and the occurrence of thermal effects. This insight would help to optimize treatment protocols and effectively ablate a tumor while controlling the occurrence of thermal effects. Methods: Various individual studies report the influence of variation in electroporation parameters on the ablation zone size or occurrence of thermal effects. However, no connections have yet been established between these studies. With the aim of closing the gap in the understanding of and personalizing irreversible electroporation parameter settings, a systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A quality assessment was performed using an in-house developed grading tool based on components of commonly used grading domains. Data on the electroporation parameters voltage, number of electrodes, inter-electrode distance, active needle length, pulse length/number/protocol/frequency, and pulse interval were extracted. Ablation zone size and temperature data were grouped per parameter. Spearman correlation and linear regression were used to define the correlation with outcome measures. Results: A total of 7661 articles were screened, of which 18 preclinical studies (animal and phantom studies) met the inclusion criteria. These studies were graded as moderate (4/18) and low (14/18) quality. Only the applied voltage appeared to be a significant linear predictor of ablation zone size: length, surface, and volume. The pulse number was moderately but nonlinearly correlated with the ablation zone length. Thermal effects were more likely to occur for higher voltages (≥2000â V), higher number of electrodes, and increased active needle length. Conclusion: Firm conclusions are limited since studies that investigated and precisely reported the influence of electroporation parameters on the ablation zone size and thermal effects were scarce and mostly graded low quality. High-quality studies are needed to improve the predictability of the combined effect of variation in parameter combinations and optimize irreversible electroporation treatment protocols.
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Técnicas de Ablación , Electroporación , Animales , Electroporación/métodos , Temperatura , Modelos Lineales , Terapia de ElectroporaciónRESUMEN
OBJECTIVE: To perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain. SUMMARY OF BACKGROUND DATA: A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. METHODS: Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months. RESULTS: All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with 160 per patient, 162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved 4563 from a societal perspective per pain-free patient lost. CONCLUSIONS: A restrictive selection strategy for cholecystectomy saves 162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of 4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.
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Dolor Abdominal , Colecistectomía , Cálculos Biliares , Dolor Abdominal/etiología , Dolor Abdominal/cirugía , Adulto , Colecistectomía/economía , Análisis Costo-Beneficio , Femenino , Cálculos Biliares/complicaciones , Cálculos Biliares/cirugía , Humanos , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state. SUMMARY BACKGROUND DATA: More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome. METHODS: We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18âyears with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6âmonths. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. RESULTS: We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52âyears, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001. CONCLUSIONS: One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process. TRIAL REGISTRATION: The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.
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Cólico , Dispepsia , Cálculos Biliares , Síndrome del Colon Irritable , Dolor Abdominal/epidemiología , Dolor Abdominal/etiología , Colecistectomía , Cólico/epidemiología , Cólico/etiología , Cólico/cirugía , Dispepsia/complicaciones , Dispepsia/etiología , Femenino , Cálculos Biliares/complicaciones , Cálculos Biliares/cirugía , Humanos , Síndrome del Colon Irritable/complicaciones , Síndrome del Colon Irritable/epidemiología , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
OBJECTIVES: To examine general practitioners' (GP) management of cholecystolithiasis and to evaluate persisting abdominal complaints in the years after the diagnosis. DESIGN: Retrospective analysis of registry data and a subset of individual medical records. SETTING: Seventeen primary care practices affiliated with the Radboudumc Practice Based Research Network in the Netherlands. PARTICIPANTS: 633 patients with cholecystolithiasis diagnosed between 2012 and 2016. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome of this study was the healthcare utilisation of patients with cholecystolithiasis diagnosed by the GP in terms of referrals to secondary care, laboratory diagnostics, prescribed medication and the prevalence of concomitant abdominal-related diagnoses in a time interval of 3 years before and 3 years after diagnosis of cholecystolithiasis. For secondary outcomes, electronic medical records were studied from seven practices to assess emergency department visits, operation rates and repeat visits for persistent abdominal symptoms. We compared the non-referred group with the referred group. RESULTS: In 57% of patients, concomitant abdominal-related diagnoses were recorded besides the diagnosis cholecystolithiasis. In-depth analyses of 294 patients showed a referral rate of 79.3% (n=233); 62.9% (n=185) underwent cholecystectomy. After referral, 55.4% (129/233) returned to the GP for persistent abdominal symptoms. Patients returning after referral were more often treated for another abdominal-related diagnosis before cholecystolithiasis was recorded (51.9% vs 28.8%, p<0.001). CONCLUSIONS: The majority of patients in general practice with gallstones are referred and undergo cholecystectomy. Patients with concomitant abdominal-related diagnoses are likely to return to their physician. GPs should inform patients about these outcomes to improve the shared decision-making process before gallbladder surgery.
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Cálculos Biliares , Médicos Generales , Humanos , Aceptación de la Atención de Salud , Atención Primaria de Salud , Estudios RetrospectivosRESUMEN
Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) or biopsy (FNB) to diagnose lesions in the gastrointestinal tract is common. Demand for histology sampling to identify treatment-specific targets is increasing. Various core biopsy FNB needles to obtain tissue for histology are currently available, however, with variable (37-97%) histology yields. In this multicenter study, we evaluated performance, safety, and user experience of a novel device (the puncture biopsy forceps (PBF) needle). Twenty-four procedures with the PBF needle were performed in 24 patients with a suspected pancreatic lesion (n = 10), subepithelial lesion (n = 10), lymph node (n = 3), or pararectal mass (n = 1). In 20/24 (83%) procedures, the PBF needle yielded sufficient material for interpretation (sample adequacy). In 17/24 (71%), a correct diagnosis was made with the material from the PBF needle (diagnostic accuracy). All participating endoscopists experienced a learning curve. (Per)procedural technical issues occurred in four cases (17%), but there were no adverse events. The PBF needle is a safe and potentially useful device to obtain an EUS-guided biopsy specimen. As the design of the PBF needle is different to core biopsy FNB needles, specific training will likely further improve the performance of the PBF needle. Furthermore, the design of the needle needs further improvement to make it more robust in clinical practice.
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Importance: There is currently no consensus on the indication for cholecystectomy in patients with uncomplicated gallstone disease. Objective: To report on the development and validation of a multivariable prediction model to better select patients for surgery. Design, Setting, and Participants: This study evaluates data from 2 multicenter prospective trials (the previously published Scrutinizing (In)efficient Use of Cholecystectomy: A Randomized Trial Concerning Variation in Practice [SECURE] and the Standardized Work-up for Symptomatic Cholecystolithiasis [Success] trial) collected from the outpatient clinics of 25 Dutch hospitals between April 2014 and June 2019 and including 1561 patients with symptomatic uncomplicated cholelithiasis, defined as gallstone disease without signs of complicated cholelithiasis (ie, biliary pancreatitis, cholangitis, common bile duct stones or cholecystitis). Data were analyzed from January 2020 to June 2020. Exposures: Patient characteristics, comorbidity, surgical outcomes, pain, and symptoms measured at baseline and at 6 months' follow-up. Main Outcomes and Measures: A multivariable regression model to predict a pain-free state or a clinically relevant reduction in pain after surgery. Model performance was evaluated using calibration and discrimination. Results: A total of 1561 patients were included (494 patients in 7 hospitals in the development cohort and 1067 patients in 24 hospitals in the validation cohort; 6 hospitals included patients in both cohorts). In the development cohort, 395 patients (80.0%) underwent cholecystectomy. After surgery, 225 patients (57.0%) reported that they were pain free and 295 (74.7%) reported a clinically relevant reduction in pain. A multivariable prediction model showed that increased age, no history of abdominal surgery, increased visual analog scale pain score at baseline, pain radiation to the back, pain reduction with simple analgesics, nausea, and no heartburn were independent predictors of clinically relevant pain reduction after cholecystectomy. After internal validation, good discrimination was found (C statistic, 0.80; 95% CI, 0.74-0.84) between patients with and without clinically relevant pain reduction. The model had very good overall calibration and minimal underestimation of the probability. External validation indicated a good discrimination between patients with and without clinically relevant pain reduction (C statistic, 0.74; 95% CI, 0.70-0.78) and fair calibration with some overestimation of probability by the model. Conclusions and Relevance: The model validated in this study may help predict the probability of pain reduction after cholecystectomy and thus aid surgeons in deciding whether patients with uncomplicated cholelithiasis will benefit from cholecystectomy.
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Colecistectomía , Colecistitis/cirugía , Técnicas de Apoyo para la Decisión , Cálculos Biliares/cirugía , Dolor/prevención & control , Selección de Paciente , Adulto , Anciano , Colecistitis/diagnóstico , Colecistitis/etiología , Estudios de Cohortes , Femenino , Cálculos Biliares/complicaciones , Cálculos Biliares/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Dolor/diagnóstico , Dolor/etiología , Pautas de la Práctica en Medicina , Valor Predictivo de las Pruebas , Análisis de Regresión , Evaluación de SíntomasRESUMEN
OBJECTIVES: A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups. METHODS: Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30). RESULTS: Budget impact analysis showed savings of 6.7-15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between 5.4 million and 14.0 million (1.7%-5.0%). CONCLUSION: Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on June 5, 2013.
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Colecistectomía , Cálculos Biliares , Dolor Abdominal , Análisis Costo-Beneficio , Femenino , Cálculos Biliares/cirugía , Humanos , Masculino , Países BajosRESUMEN
BACKGROUND: Preoperative differentiation between neoplastic and nonneoplastic gallbladder polyps, and the subsequent indication for cholecystectomy remains a clinical dilemma. The current 1 cm size threshold for neoplasia is unspecific. The aim of this study was to improve diagnostic work-up for gallbladder polyps using sonographic and MRI characteristics of neoplastic and nonneoplastic polyps. METHODS: A prospective, exploratory study including patients undergoing cholecystectomy for gallbladder polyp(s) was conducted. Patients underwent targeted transabdominal ultrasound (TAUS) and MRI. Outcomes were sensitivity and specificity for polyp diagnosis, and the radiological characteristics of neoplastic and nonneoplastic polyp types. Histopathology after cholecystectomy was used as reference standard. RESULTS: Histopathology demonstrated gallbladder polyps in 20/27 patients (74%): 14 cholesterol polyps, three adenomyomatosis, two adenomas and one gastric heterotopia. Sensitivity of polyp identification were 72% (routine TAUS) and 86% (targeted TAUS and MRI). Both adenomas were identified as neoplastic on targeted TAUS and MRI. Sonographic presentation as multiple, pedunculated polyps, either heterogeneous or with hyperechoic foci, or as single polyps containing cysts were limited to nonneoplastic polyps. On MRI hyperintense polyps on T1-weighted image were cholesterol polyps. An adenoma with high-grade dysplasia showed foci of decreased ADC values. We propose a checklist for polyp evaluation by targeted TAUS and a flowchart for radiological work-up of gallbladder polyps. CONCLUSIONS: The presented checklist and flowchart could aid diagnostic work-up for gallbladder polyps compared to current routine ultrasound, by elimination of nonneoplastic polyps and ultimately improve treatment decision for patients with gallbladder polyps.
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Enfermedades de la Vesícula Biliar/diagnóstico por imagen , Interpretación de Imagen Asistida por Computador , Imagen por Resonancia Magnética , Pólipos/diagnóstico por imagen , Ultrasonografía , Colecistectomía , Medios de Contraste , Femenino , Enfermedades de la Vesícula Biliar/patología , Enfermedades de la Vesícula Biliar/cirugía , Humanos , Masculino , Meglumina , Persona de Mediana Edad , Países Bajos , Compuestos Organometálicos , Pólipos/patología , Pólipos/cirugía , Estudios Prospectivos , Sensibilidad y EspecificidadRESUMEN
The final ablation zone created with irreversible electroporation (IRE) depends on the size, shape and strength of the electric field that is influenced by several parameters. A profound understanding of the effect of IRE parameter alterations on the electric field are a prerequisite for a safe and effective treatment. Here, we demonstrate a semolina in castor oil model that enables visualization of the static electric field developed by a high-voltage generator between two needle-electrodes. We intuitively visualize the variation in electric field line pattern for selected IRE parameters; active needle length, inter-needle distance, applied voltage and presence of a nearby metal stent, by cameras in three dimensions. The observations were compared to and supported by two-dimensional numerical simulations of the electric field. Our semolina model visualizes the disturbance of the electric field by a metal stent, potentially leading to an incomplete tumour ablation between the needles. The reduction in electric field strength and the area at risk for incomplete tumour ablation are confirmed by the numerical simulations. The semolina model provides insight in the fundamental physics of the electric field, the effect of alterations in IRE parameter combinations and presence of a metal stent within the ablation zone.
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OBJECTIVES: Obesity is a risk factor for several phenotypes such as gallstones, metabolic syndrome (MS), and nonalcoholic fatty liver disease (NAFLD). It has been suggested that cholecystectomy is a risk factor for metabolic abnormalities and NAFLD. We aimed to determine whether cholecystectomy is associated with MS or NAFLD in a Dutch population-based study. METHODS: The Rotterdam Study is an ongoing prospective population-based cohort. We included participants who underwent a liver ultrasound between 2009 and 2014 to assess steatosis. The prevalence of MS and NAFLD was calculated, and we performed regression analyses relating cholecystectomy with MS and NAFLD and adjusted for age, sex, study cohort, education level, physical activity, energy intake, time since cholecystectomy, body mass index, presence of hypertension, diabetes mellitus, and steatosis/MS. RESULTS: We included 4,307 participants (57.5% women, median age 66.0 years [interquartile range 58-74]). In total, 265 participants (6.2%) underwent a cholecystectomy. The median age at the time of cholecystectomy was 57.0 years (47.5-66.5), and the median time from cholecystectomy to imaging of the liver was 10.0 years (0.5-19.5). The prevalence of MS in participants with cholecystectomy was 67.2% and 51.9% in participants without cholecystectomy (P < 0.001). Ultrasound diagnosed moderate/severe NAFLD was present in, respectively, 42.7% and 34.2% of the participants (P = 0.008). After multivariable adjustments for metabolic factors, cholecystectomy was no longer associated with the presence of MS or NAFLD. DISCUSSION: The prevalence of MS and NAFLD is higher in participants after cholecystectomy. However, our trial shows that cholecystectomy may not be independently associated with the presence of MS and NAFLD after correction for metabolic factors.
Asunto(s)
Colecistectomía/efectos adversos , Síndrome Metabólico/epidemiología , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Anciano , Índice de Masa Corporal , Factores de Confusión Epidemiológicos , Femenino , Humanos , Hígado/diagnóstico por imagen , Masculino , Síndrome Metabólico/etiología , Persona de Mediana Edad , Países Bajos , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Enfermedad del Hígado Graso no Alcohólico/etiología , Prevalencia , Estudios Prospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , UltrasonografíaRESUMEN
BACKGROUND: Re-resection for incidental gallbladder cancer (iGBC) is associated with improved survival but little is known about residual disease (RD) and prognostic factors. In this study, survival after re-resection, RD, and prognostic factors are analyzed. METHODS: Patients with iGBC were identified from the Netherlands Cancer Registry, and pathology reports of re-resected patients were reviewed. Survival and prognostic factors were analyzed. RESULTS: Overall, 463 patients were included; 24% (n = 110) underwent re-resection after a median interval of 66 days. RD was present in 35% of patients and was most frequently found in the lymph nodes (23%). R0 resection was achieved in 93 patients (92%). Median overall survival (OS) of patients without re-resection was 13.7 (95% confidence interval [CI] 11.6-15.6), compared with 52.6 months (95% CI 36.3-68.8) in re-resected patients (p < 0.001). After re-resection, median OS was superior in patients without RD versus patients with RD (not reached vs. 23.1 months; p < 0.001). In patients who underwent re-resection, RD in the liver (hazard ratio [HR] 5.54; p < 0.001) and lymph nodes (HR 2.35; p = 0.005) were the only significant prognostic factors in multivariable analysis. Predictive factors for the presence of RD were pT3 stage (HR 25.3; p = 0.003) and pN1 stage (HR 23.0; p = 0.022). CONCLUSION: Re-resection for iGBC is associated with improved survival but remains infrequently used and is often performed after the optimal timing interval. RD is the only significant prognostic factor for survival after re-resection and can be predicted by pT and pN stages.
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Neoplasias de la Vesícula Biliar/patología , Neoplasias de la Vesícula Biliar/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Colecistectomía , Femenino , Neoplasias de la Vesícula Biliar/mortalidad , Humanos , Hallazgos Incidentales , Ganglios Linfáticos/patología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Neoplasia Residual , Países Bajos/epidemiología , Valor Predictivo de las Pruebas , Sistema de Registros , Reoperación , Estudios Retrospectivos , Análisis de SupervivenciaRESUMEN
Cholecystolithiasis and functional gastrointestinal disorders are both highly prevalent in the industrialized world and may exist concomitantly. The presence of both conditions impedes identification of the source of symptoms, leading to a risk of ineffective cholecystectomies with lack of symptom resolution. We carried out a systematic review and meta-analysis to determine the prevalence of dyspepsia in patients with uncomplicated cholecystolithiasis. The electronic databases Medline, Embase, and Web of Science were searched for articles reporting the prevalence of dyspepsia in adults (≥18 years) with uncomplicated cholecystolithiasis. Pooled prevalence and 95% confidence interval were calculated. I statistics were used to determine heterogeneity and the Methodological Evaluation of Observational Research criteria were applied for quality assessment. The study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Of the 1696 studies evaluated, 13 reported the prevalence of dyspepsia in a total of 1227 cholecystolithiasis patients seeking medical care. The pooled prevalence of dyspepsia in patients with cholecystolithiasis was 65.7% (95% confidence interval: 51-79%). However, heterogeneity was large across studies. Overall, three studies used validated diagnostic criteria. Variation in diagnostic measures significantly influenced the prevalence of dyspepsia. In conclusion, symptoms similar to those of functional gastrointestinal disorders are common in patients with cholecystolithiasis, obscuring the source of abdominal complaints. Tools to select patients who will benefit from cholecystectomy are paramount to prevent ineffective surgery.