Introduction: Currently, selection for cholecystectomy in patients with uncomplicated cholecystolithiasis is based on the Rome-III criteria; severe pain attacks, in the right upper quadrant, and lasting 15-30 minutes or longer. This study evaluates these Rome-criteria and a new prediction model based on pre-operative variables for outcome after cholecystectomy. Methods: In two multicenter, prospective trials, the SECURE and SUCCESS, patients from 25 Dutch hospitals with symptomatic, uncomplicated cholecystolithiasis were included between April'14-June'19. We evaluated the Rome-criteria to predict a pain-free state or clinically relevant pain reduction after surgery. Furthermore, we developed and validated a multivariable model to predict both outcomes after surgery. Model performance was evaluated using calibration and discrimination. Results: We included 1,561 patients, of which 494 patients in the SUCCESS cohort. In the SUCCESS cohort, 80% underwent cholecystectomy. After, 57% was pain-free and 80% reported a clinically relevant pain reduction. A prediction model based on the Rome-criteria poorly predicted a pain-free state or clinically relevant pain reduction (c-statistic 0.56 (95%CI 0.50-0.61) and 0.59 (95%CI 0.50-0.67), respectively). A multivariable model showed that increased age, no history of abdominal surgery, increased baseline VAS pain-score, pain-radiation to the back, pain-reduction with simple analgesics, nausea, and no heartburn are independent predictors of clinically relevant post-operative pain reduction. After validation, good discrimination between patients with and without clinically relevant pain reduction was found (c-statistic 0.80 (95%CI 0.74-0.84). Conclusion: A comprehensive model with the SUCCESS-criteria better predicts outcome in patients after a cholecystectomy compared with a prediction model based on current Rome-III criteria.
OBJECTIVESOptimal treatment of stage IIIA (N2) non-small-cell lung cancer (NSCLC) is controversial. Guidelines advise induction therapy before surgical resection. A proportion of patients with cN0 NSCLC are postoperatively upstaged due to unsuspected N2 disease. Survival of unsuspected N2 NSCLC treated with surgery varies and technical feasibility of video-assisted thoracic surgery (VATS) is unknown. The purpose of this study was to assess prevalence and survival of unsuspected N2 NSCLC treated with thoracotomy or VATS.METHODSA systematic review and meta-analysis was performed of all available literatures through Pubmed, Cochrane, EMBASE, Web of Science, Trials registries and System for Information on Grey Literature (SIGLE) from 2000 to 2019. Outcomes of interest were prevalence, overall survival (OS) and disease-free survival of unsuspected N2 NSCLC. Secondary outcomes were number of harvested lymph nodes, postoperative complications and survival of unsuspected N2 NSCLC treated with VATS.RESULTSSeventeen studies with patients with clinical stage N0-1 and unsuspected pN2 NSCLC were included. Prevalence of unsuspected pN2 was 8.6%. Three- and 5-year OS was 58% [95% confidence interval (CI) 37-78%) (N = 4337] and 35% (95% CI 28-43%) (N = 4337). Three- and 5-y ear disease-free survival was 48% (95% CI 30-66%) (N = 109) and 35% (95% CI 24-46%) (N = 517). VATS resulted in a low complication rate with similar 5-year OS as thoracotomy.CONCLUSIONSIn patients with cN0-1 NSCLC, a minority has unsuspected pN2 NSCLC. Even for these patients, 5-year OS and disease-free survival are reasonable. VATS with adequate lymph node dissection is the treatment of choice when in experienced hands. Adjuvant therapy should be provided in absence of relevant comorbidity.
Background: The optimal treatment of stage I non-small-cell lung carcinoma is subject to debate. The aim of this study was to compare overall survival and oncologic outcomes of lobar resection (LR), sublobar resection (SR), and stereotactic body radiotherapy (SBRT). Methods: A systematic review and meta-analysis of oncologic outcomes of propensity matched comparative and noncomparative cohort studies was performed. Outcomes of interest were overall survival and disease-free survival. The inverse variance method and the random-effects method for meta-analysis were utilized to assess the pooled estimates. Results: A total of 100 studies with patients treated for clinical stage I non-small-cell lung carcinoma were included. Long-term overall and disease-free survival after LR was superior over SBRT in all comparisons, and for most comparisons, SR was superior to SBRT. Noncomparative studies showed superior long-term overall and disease-free survival for both LR and SR over SBRT. Although the papers were heterogeneous and of low quality, results remained essentially the same throughout a large number of stratifications and sensitivity analyses. Conclusion: Results of this systematic review and meta-analysis showed that LR has superior outcomes compared to SBRT for cI non-small-cell lung carcinoma. New trials are underway evaluating long-term results of SBRT in potentially operable patients. (C) 2020 Elsevier Inc. All rights reserved.
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.
BACKGROUND:Previous analysis of Dutch practice in treatment of left-sided obstructive colon cancer (LSOCC) until 2012 showed that emergency resection (ER) was preferred, with high mortality in patients aged ≥70 years. Consequently, Dutch and European guidelines in 2014 recommended a bridge to surgery (BTS) with either self-expandable metal stent (SEMS) or decompressing stoma (DS) in high-risk patients. The implementation and effects of these guidelines have not yet been evaluated. Therefore, our aim was to perform an in-depth update of national practice concerning curative treatment of LSOCC, including an evaluation of guideline implementation.PATIENTS AND METHODS:This multicenter cohort study was conducted in 75 of 77 hospitals in the Netherlands. We included data on patients who underwent curative resection of LSOCC in 2009 through 2016 obtained from the Dutch ColoRectal Audit. Additional data were retrospectively collected.RESULTS:A total of 2,587 patients were included (2,013 ER, 345 DS, and 229 SEMS). A trend was observed in reversal of ER (decrease from 86.2% to 69.6%) and SEMS (increase from 1.3% to 7.8%) after 2014, with an ongoing increase in DS (from 5.2% in 2009 to 22.7% in 2016). DS after 2014 was associated with more laparoscopic resections (66.0% vs 35.5%; P<.001) and more 2-stage procedures (41.5% vs 28.6%; P=.01) with fewer permanent stomas (14.7% vs 29.5%; P=.005). Overall, more laparoscopic resections (25.4% vs 13.2%; P<.001) and shorter total hospital stays (14 vs 15 days; P<.001) were observed after 2014. However, similar rates of primary anastomosis (48.7% vs 48.6%; P=.961), 90-day complications (40.4% vs 37.9%; P=.254), and 90-day mortality (6.5% vs 7.0%; P=.635) were observed.CONCLUSIONS:Guideline revision resulted in a notable change from ER to BTS for LSOCC. This was accompanied by an increased rate of laparoscopic resections, more 2-stage procedures with a decreased permanent stoma rate in patients receiving DS as BTS, and a shorter total hospital stay. However, overall 90-day complication and mortality rates remained relatively high.
Introduction: Stereotactic body radiation therapy (SBRT) is a promising curative treatment for early-stage NSCLC. It is unclear if survival outcomes for SBRT are influenced by a lack of pathological confirmation of malignancy and staging of disease in these patients. In this systematic review and meta-analysis, we assess survival outcomes after SBRT in studies with patients with clinically diagnosed versus biopsy-proven early-stage NSCLC. Methods: The main databases were searched for trials and cohort studies without restrictions to publication status or language. Two independent researchers performed the screening and selection of eligible studies. Outcomes were overall survival, cancer-specific survival, and disease-free survival. The inverse variance method and the random effects method for meta-analysis were used to assess pooled survival estimates. Results: A total of 11,195 nonduplicate records were identified by the original search strategy. After screening by title and abstract, 1051 potentially eligible records were identified. A total of 43 articles were included. The comparative studies showed lower 3-year overall survival and lower 2-year and 5-year cancer-specific survival for biopsy-proven disease compared to clinical disease. However, 5-year overall survival was the same for both groups. For the pooled estimates, 3-year disease-free survival and 2-year cancer-specific survival were lower for biopsied disease. Conclusions: Results of this systematic review and meta-analysis show a discrepancy in oncological outcomes for patients undergoing SBRT for suspected early-stage NSCLC in whom there is pathologic conformation of malignancy and those who there is only a clinical diagnose of NSCLC. These results emphasize the importance of obtaining pathologic proof of malignancy. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark.
Objective: To evaluate and compare the overall survival (OS) in case-matched patient groups treated either with systemic therapy or surgery for colorectal liver metastases (CRLM).Methods: Patients with CRLM, without extra-hepatic disease, treated with chemotherapy with or without targeted therapy in two phase III studies (n = 480) were selected and case-matched to patients who underwent liver resection (n = 632). Matching criteria were sex, age, established prognostic factors for survival (clinical risk score). Available computed tomography (CT)-scans of patients treated with systemic therapies were reviewed by three independent liver surgeons for resectability. Survival was compared between patients with resectable CRLM (based on CT-scan review) who were treated with systemic therapy versus patients who underwent liver resection.Results: A total of 96 patients treated with systemic therapy were included. Pre-treatment CT-scans of the liver were available for review in 56 of the systemically treated patients, and metastases were unanimously considered resectable in 36 patients (64.3%) (complex resectable: n = 25; 69%). These 36 patients were case-matched with 36 patients who underwent liver resection (wedge resection or segmentectomy: n = 26; 72%). Median OS in the patient group treated with systemic therapy was 26.5 months (range 0-81 months), which was significantly lower than that in case-matched patients who underwent liver resection (median OS 56 months; range 6-116) (p = 0.027).Conclusions: In this case-matched control study, surgery provided superior OS rates compared to systemic therapy for CRLM. Resection of CRLM should always be considered, preferably in a dedicated liver centre, since not all patients that qualify for resection are identified as such. (C) 2016 Elsevier Ltd. All rights reserved.
ObjectiveTo evaluate and compare the overall survival (OS) in case-matched patient groups treated either with systemic therapy or surgery for colorectal liver metastases (CRLM).MethodsPatients with CRLM, without extra-hepatic disease, treated with chemotherapy with or without targeted therapy in two phase III studies (n = 480) were selected and case-matched to patients who underwent liver resection (n = 632). Matching criteria were sex, age, established prognostic factors for survival (clinical risk score). Available computed tomography (CT)-scans of patients treated with systemic therapies were reviewed by three independent liver surgeons for resectability. Survival was compared between patients with resectable CRLM (based on CT-scan review) who were treated with systemic therapy versus patients who underwent liver resection.ResultsA total of 96 patients treated with systemic therapy were included. Pre-treatment CT-scans of the liver were available for review in 56 of the systemically treated patients, and metastases were unanimously considered resectable in 36 patients (64.3%) (complex resectable: n = 25; 69%). These 36 patients were case-matched with 36 patients who underwent liver resection (wedge resection or segmentectomy: n = 26; 72%). Median OS in the patient group treated with systemic therapy was 26.5 months (range 0–81 months), which was significantly lower than that in case-matched patients who underwent liver resection (median OS 56 months; range 6–116) (p = 0.027).ConclusionsIn this case-matched control study, surgery provided superior OS rates compared to systemic therapy for CRLM. Resection of CRLM should always be considered, preferably in a dedicated liver centre, since not all patients that qualify for resection are identified as such.
BACKGROUND:For a selection of patients with colorectal liver metastases (CRLM), liver resection is a curative option. In order to predict long-term survival, clinicopathologic risk scores have been developed, but little is known about histologic factors and their prognostic value for disease-free and overall survival. The objective of the present study was to assess possible prognostic histologic factors in patients with solitary CRLM treated with liver resection who did not receive neoadjuvant treatment.METHODS:Patients with solitary CRLM who underwent liver resection between 1992 and 2011 were evaluated for clinical prognostic factors. Histologic analyses on tumor thickness at the tumor-normal interface, presence of a fibrotic capsule, intrahepatic vascular invasion, lymphatic invasion, or bile duct invasion and perineural growth were performed, using immunohistochemistry.RESULTS:A total of 124 patients were analyzed with a median follow-up of 41 months (range 1-232 months). There was no association between histologic factors and disease-free survival in multivariate analysis. In multivariate analysis, intrahepatic lymphatic invasion was associated with a decreased overall survival (41.9 vs. 61.0 months; p = 0.041), especially in combination with vascular invasion (n = 15) (28.1 vs. 62.2 months; p < 0.0001). In addition, size over 50 mm (29.2 vs. 65.9 months; p = 0.004) and interval less than 12 months between resection of the primary tumor and diagnosis of liver metastasis (49.0 vs. 91.5 months: p = 0.019) were also independent adverse prognostic factors.CONCLUSIONS:Intrahepatic lymphatic invasion, especially in combination with vascular invasion, is an important adverse prognostic factor for overall survival in patients with solitary CRLM after liver resection.
Background: The aim of this study was to determine whether selection with fluorine-18-deoxyglucose positron emission tomography (FDG-PET) imaging would result in an improved outcome in surgically treated patients with curative resection of colorectal liver metastases (CRLM), stratified by the clinical risk score (CRS) of Fong et al. [Ann Surg 1999;230:309-318]. Patients and Methods: Between January 2000 and December 2009, all patients who underwent resection for CRLM from two different university teaching hospitals in the Netherlands were analysed. Patients were stratified by the CRS. Results: In total 613 patients were eligible for analysis. There was no statistical difference in median disease-free survival (DFS) between patients with and without an FDG-PET scan in both low CRS [17 months (95% CI 12-22) vs. 14 months (95% CI 11-17), p = 0.332] and high CRS [14 months (95% CI 7-21) vs. 9 months (95% CI 8-10), p = 0.073]. There was no statistical difference in median overall survival (OS) between patients with and without an FDG-PET scan in both low CRS [64 months (95% CI 54-74) vs. 54 months (95% CI 42-66), p = 0.663] and high CRS [39 months (95% CI 23-55) vs. 41 months (95% CI 34-48), p = 0.903]. Conclusion: The present study could not demonstrate that patients selected by an FDG-PET scan before liver resection, and stratified by CRS, have an improvement in DFS or OS.
Background: Increasing numbers of patients will be selected for resection of metastatic colorectal disease, especially in case of liver metastases. Clinical scoring systems have been developed to predict overall survival after liver resection, and some correlations have been established for characteristics of the primary tumor. Data on the impact of pathologic factors of the resection specimen is limited. Systematic analysis of the resection specimens is required to optimize diagnostic reporting.
Surgical treatment of colorectal liver metastases has become increasingly aggressive. The influence of this more active surgical approach on patients' health-related quality of life (HRQoL) has hardly been evaluated. This study investigated the impact of surgical and systemic treatment on HRQoL in patients undergoing hepatic resection for colorectal metastases. A total of 145 patients with colorectal liver metastases were entered prospectively into the study. Based on HRQoL values derived from the EuroQol—5D, health summary measures were calculated to express the overall impact on four distinct clinical states. The HRQoL instrument was used at baseline, 3 and 6 weeks after surgery, and every 3 months thereafter for up to 3 years. Patients showed a clear deterioration in HRQoL in the first weeks after surgery, followed by a recovery to baseline levels at 3 months after potentially curative surgery. In contrast, a sustained decline was noted when initial surgery for colorectal liver metastases was considered futile and palliative chemotherapy was started immediately. Three years after initial surgery, there were distinct differences in HRQoL between patients with or without recurrence. The latter group still had HRQoL scores at baseline levels, whereas patients with tumour recurrence showed a significant deterioration in HRQoL. Remarkably, there was no decline in HRQoL in patients with recurrent disease who could be treated by secondary surgical intervention. Superior overall HRQoL in the first 3 years after initial successful surgical intervention merits an aggressive surgical approach and intensive follow-up to detect recurrence early. Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Objective[F-18]-Fluorodeoxyglucose-positron emission tomography (FDG-PET) is used increasingly in the work-up to surgery for patients with potentially resectable colorectal liver metastases. This study evaluates the clinical effectiveness, impact on health care resources and cost-effectiveness of adding FDG-PET to the diagnostic algorithm alongside a randomized clinical trial from a health care perspective. MethodsIn a randomized clinical trial, the net monetary benefit (NMB) of FDG-PET added to conventional diagnostic work-up (CWU) was determined in patients with colorectal liver metastases. Seventy-five patients were included in each arm. Change in clinical management, futile laparotomies, preoperative findings and all relevant health care consumption were prospectively documented during 3 years. To assess health-related quality of life European Quality of Life-5 Dimensions was administered at the time of randomization, 3 and 6 weeks postoperatively, and every 3 months postoperatively for 3 years. Quality-adjusted life years (QALYs) were calculated based on European Quality of Life-5 Dimensions outcomes. ResultsIn adding FDG-PET, diagnostic performance increased and futile laparotomies were reduced by 38%. Both health-related quality of life and QALYs showed no significant difference between the CWU and PET groups. For CWU and PET groups costs were &OV0556;92 836 and &OV0556;81 776, respectively, accumulated in 3 years after randomization. NMB ranged from &OV0556;1004 to &OV0556;11 060 depending on the monetary value given to a QALY. When costs for chemotherapy were disregarded, costs amounted to &OV0556;15 874 for CWU and &OV0556;18 664 for PET group. ConclusionAdditional costs of FDG-PET in the diagnostic work-up of patients with potentially resectable colorectal liver metastases were compensated by a reduction in futile laparotomies. The NMB analysis showed savings over a relevant range of willingness to pay for a QALY.
After the successful Postgraduate Courses of the last two years in Kaunas, Lithuania, and Sofi a, Bulgaria, we are pleased to inform you that this year’s EDS Postgraduate Course will be held in Belgrade, Serbia, from October 23 to 24. Professor Miroslav Milicevic and Dr. Dejan Radenkovic will organize an exclusive and scientifi cally outstanding event for all EDS members. Details regarding the scientifi c program will be announced soon.