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1.
Eur J Surg Oncol ; 50(6): 108264, 2024 Jun.
Article En | MEDLINE | ID: mdl-38537366

BACKGROUND: In 2013, the nationwide Dutch Hepato Biliary Audit (DHBA) was initiated. The aim of this study was to evaluate changes in indications for and outcomes of liver surgery in the last decade. METHODS: This nationwide study included all patients who underwent liver surgery for four indications, including colorectal liver metastases (CRLM), hepatocellular carcinoma (HCC), and intrahepatic- and perihilar cholangiocarcinoma (iCCA - pCCA) between 2014 and 2022. Trends in postoperative outcomes were evaluated separately for each indication using multilevel multivariable logistic regression analyses. RESULTS: This study included 8057 procedures for CRLM, 838 for HCC, 290 for iCCA, and 300 for pCCA. Over time, these patients had higher risk profiles (more ASA-III patients and more comorbidities). Adjusted mortality decreased over time for CRLM, HCC and iCCA, respectively aOR 0.83, 95%CI 0.75-0.92, P < 0.001; aOR 0.86, 95%CI 0.75-0.99, P = 0.045; aOR 0.40, 95%CI 0.20-0.73, P < 0.001. Failure to rescue (FTR) also decreased for these groups, respectively aOR 0.84, 95%CI 0.76-0.93, P = 0.001; aOR 0.81, 95%CI 0.68-0.97, P = 0.024; aOR 0.29, 95%CI 0.08-0.84, P = 0.021). For iCCA severe complications (aOR 0.65 95%CI 0.43-0.99, P = 0.043) also decreased. No significant outcome differences were observed in pCCA. The number of centres performing liver resections decreased from 26 to 22 between 2014 and 2022, while median annual volumes did not change (40-49, P = 0.66). CONCLUSION: Over time, postoperative mortality and FTR decreased after liver surgery, despite treating higher-risk patients. The DHBA continues its focus on providing feedback and benchmark results to further enhance outcomes.


Carcinoma, Hepatocellular , Colorectal Neoplasms , Hepatectomy , Liver Neoplasms , Humans , Netherlands/epidemiology , Liver Neoplasms/surgery , Liver Neoplasms/secondary , Male , Female , Middle Aged , Aged , Carcinoma, Hepatocellular/surgery , Carcinoma, Hepatocellular/mortality , Colorectal Neoplasms/surgery , Colorectal Neoplasms/pathology , Cholangiocarcinoma/surgery , Cholangiocarcinoma/pathology , Bile Duct Neoplasms/surgery , Bile Duct Neoplasms/pathology , Failure to Rescue, Health Care , Postoperative Complications/epidemiology , Medical Audit , Treatment Outcome , Klatskin Tumor/surgery , Klatskin Tumor/pathology , Klatskin Tumor/mortality
3.
Eur J Surg Oncol ; 48(12): 2414-2423, 2022 Dec.
Article En | MEDLINE | ID: mdl-35773091

INTRODUCTION: Textbook outcome (TO) is a composite outcome measure covering the surgical care process in a single outcome measure. TO has an advantage over single outcome parameters with low event rates, which have less discriminating impact to detect differences between hospitals. This study aimed to assess factors associated with TO, and evaluate hospital and network variation after case-mix correction in TO rates for liver surgery. METHODS: This was a population-based retrospective study of all patients who underwent liver resection for malignancy in the Netherlands in 2019 and 2020. TO was defined as absence of severe postoperative complications, mortality, prolonged length of hospital stay, and readmission, and obtaining adequate resection margins. Multivariable logistic regression was used for case-mix adjustment. RESULTS: 2376 patients were included. TO was accomplished in 1380 (80%) patients with colorectal liver metastases, in 192 (76%) patients with other liver metastases, in 183 (74%) patients with hepatocellular carcinoma and 86 (51%) patients with biliary cancers. Factors associated with lower TO rates for CRLM included ASA score ≥3 (aOR 0.70, CI 0.51-0.95 p = 0.02), extrahepatic disease (aOR 0.64, CI 0.44-0.95, p = 0.02), tumour size >55 mm on preoperative imaging (aOR 0.56, CI 0.34-0.94, p = 0.02), Charlson Comorbidity Index ≥2 (aOR 0.73, CI 0.54-0.98, p = 0.04), and major liver resection (aOR 0.50, CI 0.36-0.69, p < 0.001). After case-mix correction, no significant hospital or oncological network variation was observed. CONCLUSION: TO differs between indications for liver resection and can be used to assess between hospital and network differences.


Hepatectomy , Liver Neoplasms , Humans , Retrospective Studies , Hepatectomy/adverse effects , Hospitals , Length of Stay , Liver Neoplasms/surgery , Liver Neoplasms/complications , Postoperative Complications/epidemiology , Postoperative Complications/etiology
4.
Eur J Surg Oncol ; 48(2): 435-448, 2022 Feb.
Article En | MEDLINE | ID: mdl-34801321

INTRODUCTION: Widespread differences in patient demographics and disease burden between hospitals for resection of colorectal liver metastases (CRLM) have been described. In the Netherlands, networks consisting of at least one tertiary referral centre and several regional hospitals have been established to optimize treatment and outcomes. The aim of this study was to assess variation in case-mix, and outcomes between these networks. METHODS: This was a population-based study including all patients who underwent CRLM resection in the Netherlands between 2014 and 2019. Variation in case-mix and outcomes between seven networks covering the whole country was evaluated. Differences in case-mix, expected 30-day major morbidity (Clavien-Dindo ≥3a) and 30-day mortality between networks were assessed. RESULTS: In total 5383 patients were included. Thirty-day major morbidity was 5.7% and 30-day mortality was 1.5%. Significant differences between networks were observed for Charlson Comorbidity Index, ASA 3+, previous liver resection, liver disease, preoperative MRI, preoperative chemotherapy, ≥3 CRLM, diameter of largest CRLM ≥55 mm, major resection, combined resection and ablation, rectal primary tumour, bilobar and extrahepatic disease. Uncorrected 30-day major morbidity ranged between 3.3% and 13.1% for hospitals, 30-day mortality ranged between 0.0% and 4.5%. Uncorrected 30-day major morbidity ranged between 4.4% and 6.0% for networks, 30-day mortality ranged between 0.0% and 2.5%. No negative outliers were observed after case-mix correction. CONCLUSION: Variation in case-mix and outcomes are considerably smaller on a network level as compared to a hospital level. Therefore, auditing is more meaningful at a network level and collaboration of hospitals within networks should be pursued.


Carcinoma/surgery , Colorectal Neoplasms/pathology , Hepatectomy , Liver Neoplasms/surgery , Metastasectomy , Postoperative Complications/epidemiology , Aged , Aged, 80 and over , Carcinoma/secondary , Diagnosis-Related Groups , Female , Hospital Planning , Hospitals , Humans , Liver Neoplasms/secondary , Magnetic Resonance Imaging , Male , Middle Aged , Mortality , Neoadjuvant Therapy , Netherlands , Tertiary Care Centers
5.
HPB (Oxford) ; 23(10): 1506-1517, 2021 10.
Article En | MEDLINE | ID: mdl-33926842

BACKGROUND: Liver resection is high-risk surgery in particular in elderly patients. The aim of this study was to explore postoperative outcomes after liver resection in elderly patients. METHODS: In this nationwide study, all patients who underwent liver resection for primary and secondary liver tumours in the Netherlands between 2014 and 2019 were included. Age groups were composed as younger than 70 (70-), between 70 and 80 (septuagenarians), and 80 years or older (octogenarians). Proportion of liver resections per age group and 30-day major morbidity and 30-day mortality were assessed. RESULTS: In total, 6587 patients were included of whom 4023 (58.9%) were younger than 70, 2135 (32.4%) were septuagenarians and 429 (6.5%) were octogenarians. The proportion of septuagenarians increased during the study period (aOR:1.06, CI:1.02-1.09, p < 0.001). Thirty-day major morbidity was higher in septuagenarians (11%) and octogenarians (12%) compared to younger patients (9%, p = 0.049). Thirty-day mortality was higher in septuagenarians (4%) and octogenarians (4%) compared to younger patients (2%, p < 0.001). Cardiopulmonary complications occurred more frequently with higher age, liver-specific complications did not. Higher age was associated with higher 30-day morbidity and 30-day mortality in multivariable logistic regression. CONCLUSION: Thirty-day major morbidity and 30-day mortality are higher after liver resection in elderly patients, attributed mainly to non-surgical cardiopulmonary complications.


Liver , Octogenarians , Age Factors , Aged , Aged, 80 and over , Humans , Netherlands , Postoperative Complications/etiology , Retrospective Studies
6.
Cochrane Database Syst Rev ; 12: CD007561, 2020 12 01.
Article En | MEDLINE | ID: mdl-33258499

BACKGROUND: Atherosclerosis of the iliac artery may result in a stenosis or occlusion, which is defined as iliac artery occlusive disease. A range of surgical and endovascular treatment options are available. Open surgical procedures have excellent patency rates but at the cost of substantial morbidity and mortality. Endovascular treatment has good safety and short-term efficacy with decreased morbidity, complications and costs compared with open surgical procedures. Both percutaneous transluminal angioplasty (PTA) and stenting are commonly used endovascular treatment options for iliac artery occlusive disease. A stenotic or occlusive lesion of the iliac artery can be treated successfully by PTA alone. If PTA alone is technically unsuccessful, additional stent placement is indicated. Alternatively, a stent could be placed primarily to treat an iliac artery stenosis or occlusion (primary stenting, PS). However, there is limited evidence to prove which endovascular treatment strategy is superior for stenotic and occlusive lesions of the iliac arteries. This is an update of the review first published in 2015. OBJECTIVES: To assess the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 24 September 2019. We also undertook reference checking and citation searching to identify additional studies. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing percutaneous transluminal angioplasty and primary stenting for iliac artery occlusive disease. We excluded quasi-randomised trials, case reports, case-control or cohort studies. We did not exclude studies based on the language of publication. DATA COLLECTION AND ANALYSIS: Two authors independently selected suitable trials, extracted data, assessed trial quality and performed data analyses. When there was disagreement, consensus would be reached first by discussion between the two authors and, if needed, through consultation with a third author. We used GRADE criteria to assess the certainty of the evidence and presented the main results in a 'Summary of findings' table. The main outcomes of interest were technical success, complications, symptomatic improvement of peripheral arterial disease (PAD), patency, reinterventions, resolutions of symptoms and signs, and improvement in walking distance as reported by the patient. MAIN RESULTS: We identified no new studies for this update. Previously, we identified two RCTs, with a combined total of 397 participants, as meeting the selection criteria. One study included mostly stenotic lesions (95%), whereas the second study included only iliac artery occlusions. Heterogeneity between these two studies meant it was not possible to pool the data. Both studies were of moderate methodological quality with some risk of bias relating to selective reporting and non-blinding of participants and personnel. Both studies occurred in the 1990s and techniques have since evolved. We assessed the overall certainty of the evidence to be low. We downgraded by two levels: one for risk of bias concerns and one for imprecision and indirectness. There was no evidence of a difference following percutaneous transluminal angioplasty (PTA) with selective stenting compared to primary stenting (PS) in technical success rates in either the study involving stenotic lesions (odds ratio (OR) 1.51, 95% confidence interval (CI) 0.77 to 2.99; 279 participants; low certainty evidence); or the study involving iliac artery occlusions (OR 2.95, 95% CI 0.12 to 73.90; 112 participants; low certainty evidence). In one trial, PTA of iliac artery occlusions resulted in a higher rate of major complications, especially distal embolisation (OR 4.50 95% CI 1.18 to 17.14; 1 study, 112 participants; low certainty evidence). Immediate complications were similar in the second study (OR 1.81, 95% CI 0.64 to 5.13; 1 study, 279 participants; low certainty evidence). Neither study reported on delayed complications. No evidence of a difference was seen in symptomatic improvement (OR 1.03, 95% CI 0.47 to 2.27; 1 study, 157 participants; low certainty evidence). The second study did not provide data but reported no differences. For the outcome of patency, no evidence of a difference was seen in the study involving iliac occlusion at two years (OR 1.60, 95% CI 0.34 to 7.44; 1 study, 57 participants; low certainty evidence); or the study involving stenotic lesions at two years (71.3% in the PS group versus 69.9% in the PTA group). Only one study reported on reintervention (six to eight years, OR 1.22, 95% CI 0.67 to 2.23; 1 study, 279 participants; low certainty evidence); and resolution of symptoms and signs (12 months, OR 1.14, 95% CI 0.65 to 2.00; 1 study, 219 participants; low certainty evidence), with no evidence of a difference detected in either outcome. Neither study reported on improvement in walking distance as reported by the patient. AUTHORS' CONCLUSIONS: There is insufficient evidence to make general conclusions about the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. Data from one study indicate that primary stenting in iliac artery occlusions may result in lower distal embolisation rates (low certainty evidence). The evidence in this review, based on two studies, was assessed as low certainty, with downgrading decisions based on limitations in risk of bias, imprecision and indirectness. More studies are required to strengthen our confidence in the results.


Angioplasty/methods , Arterial Occlusive Diseases/therapy , Iliac Artery , Stents , Angioplasty/adverse effects , Constriction, Pathologic/therapy , Humans , Randomized Controlled Trials as Topic , Retreatment , Treatment Outcome
7.
Thorac Cancer ; 11(12): 3456-3462, 2020 12.
Article En | MEDLINE | ID: mdl-33026177

BACKGROUND: Endosonography is accepted as the initial procedure for mediastinal staging in patients with suspected non-small cell lung cancer (NSCLC). However, the diagnostic value of different staging methods in specific subgroups is unclear. The purpose of this study was to assess the performance and outcome of mediastinal staging in lung cancer in a general teaching hospital. METHODS: The records of 870 consecutive patients with potentially resectable NSCLC (cT1-3NxM0) were analyzed in a retrospective cohort study between January 2010 and December 2016. Patients were divided into four different groups according to ESTS guidelines. The primary endpoint was the rate of unforeseen mediastinal metastasis in these groups and the sensitivity of different staging methods. RESULTS: Mediastinal staging was performed in 336 patients of whom 112 (33%) underwent lobectomy. Unforeseen mediastinal metastasis was seen in 10 (9%) patients after negative mediastinal staging. Sensitivity after combined mediastinal staging (endosonography with mediastinoscopy) in the overall group was 94%. In patients without suspected mediastinal lymph nodes but with suspected hilar lymph nodes (N1), or a peripheral tumor >3 cm, sensitivity of endosonography was 33% and mediastinoscopy 75%. Biopsy of at least level 4L, 4R and 7 was taken in 18% of the endosonographies and 58% of the mediastinoscopies. DISCUSSION: Combined mediastinal staging (endosonography with mediastinoscopy) is reliable with a sensitivity of 94%. However, the diagnostic value of endosonography in patients with suspected hilar lymph nodes or a peripheral tumor >3 cm is questionable, and in these patients, performing direct mediastinoscopy should be considered. KEY POINTS: SIGNIFICANT FINDINGS OF THIS STUDY: The diagnostic value of endosonography in patients without suspected mediastinal lymph nodes but with potential risk factors (suspected N1 disease or peripheral tumor >3 cm) is questionable. Therefore, mediastinoscopy as the first choice should be considered in these patients. WHAT THIS STUDY ADDS?: Accurate mediastinal nodal staging is essential in patients with suspected NSCLC to avoid unnecessary lobectomy. Detailed knowledge about sensitivity and specificity of mediastinal staging techniques in different patient groups can make a difference.


Carcinoma, Non-Small-Cell Lung/pathology , Lung Neoplasms/pathology , Mediastinum/pathology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Neoplasm Staging , Preoperative Period , Retrospective Studies
8.
J Robot Surg ; 14(1): 131-136, 2020 Feb.
Article En | MEDLINE | ID: mdl-30927155

Surgical resection is the optimal procedure for early stage non-small cell lung cancer (NSCLC). Open thoracotomy, video-assisted thoracic surgery (VATS) and robot-assisted thoracic surgery (RATS) are different surgical modalities with possible different outcomes. The aim of this study was to analyze differences in outcome with a focus on postoperative pain. Patients undergoing lobectomy at the Maasstad Hospital in 2015 and 2016 were included. Postoperative pain was scored according to the Numerical Rating Scale (NRS). Additionally, duration of chest tube drainage and thoracic epidural analgesia (TEA), hospital length of stay and type of surgery were assessed. Lobectomy was performed in 57 patients. There was no significant difference in type of surgery, age, gender, right-sided surgery, postoperative NRS scores, duration of chest tube drainage and epidural anesthesia, and hospital length of stay (p > 0.05). Operative time for RATS was significantly longer (p = 0.002). Postoperative pain scores and other outcomes did not differ between the three different modalities in surgery for NSCLC. In the future, more minimally invasive surgery will be used in pulmonary surgery with thoracotomy as a safe alternative in selected cases. Future studies have to demonstrate if RATS will overcome the differences concerning cost-effectiveness over VATS.


Pain, Postoperative , Pneumonectomy , Robotic Surgical Procedures , Thoracic Surgery, Video-Assisted , Thoracic Surgical Procedures , Carcinoma, Non-Small-Cell Lung/surgery , Humans , Lung Neoplasms/surgery , Operative Time
9.
BMC Cancer ; 19(1): 390, 2019 04 25.
Article En | MEDLINE | ID: mdl-31023318

BACKGROUND: Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. METHODS: This open-label, parallel-group, phase II-III, randomised, superiority study is performed in nine Dutch tertiary referral centres. Eligible patients are adults who have a good performance status, histologically or cytologically proven resectable PM of a colorectal adenocarcinoma, no systemic colorectal metastases, no systemic therapy for colorectal cancer within six months prior to enrolment, and no previous CRS-HIPEC. Eligible patients are randomised (1:1) to perioperative systemic therapy and CRS-HIPEC (experimental arm) or upfront CRS-HIPEC alone (control arm) by using central randomisation software with minimisation stratified by a peritoneal cancer index of 0-10 or 11-20, metachronous or synchronous PM, previous systemic therapy for colorectal cancer, and HIPEC with oxaliplatin or mitomycin C. At the treating physician's discretion, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-weekly neoadjuvant and adjuvant cycles of 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX), or six 2-weekly neoadjuvant cycles of 5-fluorouracil/leucovorin with irinotecan (FOLFIRI) followed by four 3-weekly (capecitabine) or six 2-weekly (5-fluorouracil/leucovorin) adjuvant cycles of fluoropyrimidine monotherapy. Bevacizumab is added to the first three (CAPOX) or four (FOLFOX/FOLFIRI) neoadjuvant cycles. The first 80 patients are enrolled in a phase II study to explore the feasibility of accrual and the feasibility, safety, and tolerance of perioperative systemic therapy. If predefined criteria of feasibility and safety are met, the study continues as a phase III study with 3-year overall survival as primary endpoint. A total of 358 patients is needed to detect the hypothesised 15% increase in 3-year overall survival (control arm 50%; experimental arm 65%). Secondary endpoints are surgical characteristics, major postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histopathological response rates. DISCUSSION: This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM. TRIAL REGISTRATION: Clinicaltrials.gov/ NCT02758951 , NTR/ NTR6301 , ISRCTN/ ISRCTN15977568 , EudraCT/ 2016-001865-99 .


Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/surgery , Peritoneal Neoplasms/drug therapy , Peritoneum/surgery , Adult , Bevacizumab/administration & dosage , Chemotherapy, Adjuvant/adverse effects , Colorectal Neoplasms/pathology , Combined Modality Therapy , Cytoreduction Surgical Procedures/adverse effects , Disease-Free Survival , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Humans , Leucovorin/administration & dosage , Leucovorin/adverse effects , Male , Middle Aged , Neoplasm Metastasis , Oxaliplatin/administration & dosage , Oxaliplatin/adverse effects , Perioperative Period , Peritoneal Neoplasms/pathology , Peritoneal Neoplasms/secondary , Peritoneal Neoplasms/surgery , Peritoneum/drug effects , Peritoneum/pathology , Progression-Free Survival , Quality of Life
10.
Cochrane Database Syst Rev ; (5): CD007561, 2015 May 29.
Article En | MEDLINE | ID: mdl-26023746

BACKGROUND: Atherosclerosis of the iliac artery may result in a stenosis or occlusion, which is defined as iliac artery occlusive disease. A range of surgical and endovascular treatment options are available. Open surgical procedures have excellent patency rates but at the cost of substantial morbidity and mortality. Endovascular treatment has good safety and short-term efficacy with decreased morbidity, complications and costs compared with open surgical procedures. Both percutaneous transluminal angioplasty (PTA) and stenting are commonly used endovascular treatment options for iliac artery occlusive disease. A stenotic or occlusive lesion of the iliac artery can be treated successfully by PTA alone. If PTA alone is technically unsuccessful, additional stent placement is indicated. Alternatively, a stent could be placed primarily to treat an iliac artery stenosis or occlusion (primary stenting, PS). However, there is limited evidence to prove which endovascular treatment strategy is superior for stenotic and occlusive lesions of the iliac arteries. OBJECTIVES: To assess the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and Cochrane Register of Studies (CRS) (2015, Issue 3). The TSC searched trial databases for details of ongoing and unpublished studies. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing percutaneous transluminal angioplasty and primary stenting for iliac artery occlusive disease. We excluded quasi-randomised trials, case reports, case-control or cohort studies. We excluded no studies based on the language of publication. DATA COLLECTION AND ANALYSIS: Two authors (JB, NA) independently selected suitable trials. JB and HJ independently performed data extraction and trial quality assessment. When there was disagreement, consensus would be reached first by discussion among both authors and, if still no consensus could be reached, through consultation with BF. MAIN RESULTS: We identified two RCTs with a combined total of 397 participants as meeting the selection criteria. One study included mostly stenotic lesions (95%), whereas the second study included only iliac artery occlusions. Both studies were of moderate methodological quality with some risk of bias relating to selective reporting and non-blinding of participants and personnel. The overall quality of evidence was low due to the small number of included studies, the differences in study populations and definitions of the outcome variables. Due to the heterogeneity among these two studies it was not possible to pool the data. Percutaneous transluminal angioplasty (PTA) with selective stenting and primary stenting (PS) resulted in similar improvement in the stage of peripheral arterial occlusive disease according to Rutherford's criteria, resolution of symptoms and signs, improvement of quality of life, technical success of the procedure and patency of the treated vessel. Improvement in walking distance as reported by the patient, measured claudication distance, ulcer healing, major amputation-free survival and delayed complications (> 72 hours) were not reported in either of the studies. In one trial, PTA of iliac artery occlusions resulted in a significantly higher rate of major complications, especially distal embolisation. The other trial showed a significantly higher mean ankle brachial index (ABI) at two years in the PTA group (1.0) compared to the mean ABI in the PS group (0.91); mean difference (MD) 0.09 (95% confidence interval (CI) 0.04 to 0.14; P value = 0.001, analysis performed by review authors). However, at other time points there was no difference. We consider it unlikely that this difference is attributable to the study procedure, and also believe this difference may not be clinically relevant. AUTHORS' CONCLUSIONS: There is insufficient evidence to assess the effects of PTA versus PS for stenotic and occlusive lesions of the iliac artery. From one study it appears that PS in iliac artery occlusions may result in lower distal embolisation rates. More studies are required to come to a firm conclusion.


Angioplasty/methods , Iliac Artery , Peripheral Arterial Disease/therapy , Stents , Angioplasty/adverse effects , Constriction, Pathologic/therapy , Humans , Randomized Controlled Trials as Topic , Retreatment , Treatment Outcome
11.
BMC Cancer ; 15: 180, 2015 Mar 26.
Article En | MEDLINE | ID: mdl-25884448

BACKGROUND: Efforts to improve the outcome of liver surgery by combining curative resection with chemotherapy have failed to demonstrate definite overall survival benefit. This may partly be due to the fact that these studies often involve strict inclusion criteria. Consequently, patients with a high risk profile as characterized by Fong's Clinical Risk Score (CRS) are often underrepresented in these studies. Conceptually, this group of patients might benefit the most from chemotherapy. The present study evaluates the impact of neo-adjuvant chemotherapy in high-risk patients with primary resectable colorectal liver metastases, without extrahepatic disease. Our hypothesis is that adding neo-adjuvant chemotherapy to surgery will provide an improvement in overall survival (OS) in patients with a high-risk profile. METHODS/DESIGN: CHARISMA is a multicenter, randomized, phase III clinical trial. Patients will be randomized to either surgery alone (standard treatment, arm A) or to 6 cycles of neo-adjuvant oxaliplatin-based chemotherapy, followed by surgery (arm B). Patients must be ≥ 18 years of age with liver metastases of histologically confirmed primary colorectal carcinoma. Patients with extrahepatic metastases are excluded. Liver metastases must be deemed primarily resectable. Only patients with a CRS of 3-5 are eligible. The primary study endpoint is OS. Secondary endpoints are progression free survival (PFS), quality of life, morbidity of resection, treatment response on neo-adjuvant chemotherapy, and whether CEA levels can predict treatment response. DISCUSSION: CHARISMA is a multicenter, randomized, phase III clinical trial that will provide an answer to the question if adding neo-adjuvant chemotherapy to surgery will improve OS in a well-defined high-risk patient group with colorectal liver metastases. TRIAL REGISTRATION: The CHARISMA is registered at European Union Clinical Trials Register (EudraCT), number: 2013-004952-39 , and in the "Netherlands national Trial Register (NTR), number: 4893.


Colorectal Neoplasms/drug therapy , Liver Neoplasms/drug therapy , Neoadjuvant Therapy , Organoplatinum Compounds/administration & dosage , Adult , Aged , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Combined Modality Therapy , Digestive System Surgical Procedures , Disease-Free Survival , Female , Humans , Liver Neoplasms/secondary , Liver Neoplasms/surgery , Male , Middle Aged , Oxaliplatin , Risk Factors
12.
Dis Colon Rectum ; 56(3): 281-7, 2013 Mar.
Article En | MEDLINE | ID: mdl-23392140

BACKGROUND: There are no reports available on the long-term outcome of patients with the "liver first" approach. OBJECTIVES: The aim of this study was to present the long-term results of the "liver first" approach in our center. DESIGN: This study is a retrospective analysis. SETTING: This study was conducted at a tertiary referral center. PATIENTS: Patients from May 2003 to March 2009 were included. INTERVENTIONS: Patients with locally advanced rectal cancer and synchronous liver metastases were first treated for their liver metastases. If the treatment was successful, patients underwent neoadjuvant chemoradiotherapy and surgery for the rectal cancer. If metastases could not be resected, resection of the rectal primary was not routinely performed. MAIN OUTCOME MEASURES: The primary outcome measured was long-term results of the "liver first" approach. RESULTS: Of the 42 patients included (median age, 61 years), all but one (98%) started with neoadjuvant chemotherapy. In total, 31 (74%) patients completed the "liver first" approach. In 11 patients, curative therapy was not possible because of unresectable metastases; in 10 of these patients (91%), the primary tumor was not resected. LIMITATIONS: This study was limited because it was a retrospective analysis without a control group. CONCLUSIONS: By applying the "liver first" approach, the majority of this group of patients (74%) could undergo curative treatment of both metastatic and primary disease in combination with optimal neoadjuvant therapy. This strategy may avoid unnecessary rectal surgery in patients with incurable metastatic disease. In this selected patient group, long-term survival may be achieved with a 5-year survival rate of 67%.


Chemoradiotherapy/methods , Liver Neoplasms/secondary , Liver/pathology , Neoadjuvant Therapy/methods , Rectal Neoplasms/surgery , Adult , Aged , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Liver/surgery , Liver Neoplasms/surgery , Liver Neoplasms/therapy , Male , Middle Aged , Neoplasm Metastasis , Rectal Neoplasms/pathology , Rectal Neoplasms/therapy , Retrospective Studies , Survival Analysis , Treatment Outcome
13.
Ann Surg Oncol ; 20(1): 155-60, 2013 Jan.
Article En | MEDLINE | ID: mdl-22875644

BACKGROUND: There is no evidence regarding restaging of patients with locally advanced rectal cancer after a long course of neoadjuvant radiotherapy with or without chemotherapy. This study evaluated the value of restaging with chest and abdominal computed tomographic (CT) scan after radiotherapy. METHODS: Between January 2000 and December 2010, all newly diagnosed patients in our tertiary referral hospital, who underwent a long course of radiotherapy for locally advanced rectal cancer, were analyzed. Patients were only included if they had chest and abdominal imaging before and after radiotherapy treatment. RESULTS: A total of 153 patients who met the inclusion criteria and were treated with curative intent were included. A change in treatment strategy due to new findings on the CT scan after radiotherapy was observed in 18 (12%) of 153 patients. Twelve patients (8%) were spared rectal surgery due to progressive metastatic disease. CONCLUSIONS: Restaging with a chest and abdominal CT scan after radiotherapy for locally advanced rectal cancer is advisable because additional findings may alter the treatment strategy.


Adenocarcinoma/diagnostic imaging , Liver Neoplasms/diagnostic imaging , Lung Neoplasms/diagnostic imaging , Radiography, Abdominal , Radiography, Thoracic , Rectal Neoplasms/diagnostic imaging , Adenocarcinoma/secondary , Adenocarcinoma/therapy , Aged , Antimetabolites, Antineoplastic/therapeutic use , Capecitabine , Chemoradiotherapy, Adjuvant , Deoxycytidine/analogs & derivatives , Deoxycytidine/therapeutic use , Dose Fractionation, Radiation , Female , Fluorouracil/analogs & derivatives , Fluorouracil/therapeutic use , Humans , Liver Neoplasms/secondary , Lung Neoplasms/secondary , Male , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Rectal Neoplasms/pathology , Rectal Neoplasms/therapy , Rectum/surgery , Retrospective Studies , Tomography, X-Ray Computed
14.
Ann Surg Oncol ; 19(5): 1618-27, 2012 May.
Article En | MEDLINE | ID: mdl-22006375

BACKGROUND: Data from patients with colorectal liver metastases (CRLM) who received neoadjuvant chemotherapy before resection were reviewed and evaluated to see whether neoadjuvant chemotherapy influences the predictive outcome of R1 resections (margin is 0 mm) in patients with CRLM. METHODS: Between January 2000 and December 2008, all consecutive patients undergoing liver resection for CRLM were analyzed. Patients were divided into those who did and did not receive neoadjuvant chemotherapy. The outcome after R0 (tumor-free margin >0 mm) and R1 (tumor-free margin 0 mm) resection was compared. RESULTS: A total of 264 were eligible for analysis. Median follow-up was 34 months. Patients without chemotherapy showed a significant difference in median disease-free survival (DFS) after R0 or R1 resection: 17 [95% confidence interval (CI) 10-24] months versus 8 (95% CI 4-12) months (P < 0.001), whereas in patients with neoadjuvant chemotherapy the difference in DFS between R0 and R1 resection was not significant: 18 (95% CI 10-26) months versus 9 (95% CI 0-20) months (P = 0.303). Patients without chemotherapy showed a significant difference in median overall survival (OS) after R0 or R1 resection: 53 (95% CI 40-66) months versus 30 (95% CI 13-47) months (P < 0.001). In patients with neoadjuvant chemotherapy, the median OS showed no significant difference: 65 (95% CI 39-92) months for the R0 group versus the R1 group, in whom the median OS was not reached (P = 0.645). CONCLUSIONS: In patients treated with neoadjuvant chemotherapy, R1 resection was of no predictive value for DFS and OS.


Colorectal Neoplasms/pathology , Hepatectomy/methods , Liver Neoplasms/secondary , Liver Neoplasms/surgery , Metastasectomy/methods , Adult , Aged , Aged, 80 and over , Chemotherapy, Adjuvant , Colorectal Neoplasms/mortality , Female , Humans , Liver Neoplasms/drug therapy , Liver Neoplasms/mortality , Liver Neoplasms/pathology , Lymphatic Metastasis , Male , Middle Aged , Multivariate Analysis , Neoadjuvant Therapy , Neoplasm Staging , Survival Rate , Treatment Outcome
15.
J Vasc Surg ; 54(4): 1095-9, 2011 Oct.
Article En | MEDLINE | ID: mdl-21840156

BACKGROUND: Nowadays, as a result of more liberal selection criteria, dialysis-dependent patients have become substantially older, more likely to be female and diabetic, and have more comorbidity. The 1-year primary patency rates of arteriovenous fistulas (AVFs) are poor. To improve these results, several secondary interventions can be performed. The aim of this study was to evaluate the results after secondary interventions in patients with an upper extremity AVF. METHODS: Between January 2000 and December 2008, all consecutive patients who underwent construction of an autologous upper extremity AVF were included. Patient characteristics were collected retrospectively from digital patient files and a prospectively recorded database on hemodialysis patients. RESULTS: Between January 2000 and December 2008, 736 hemodialysis access procedures were performed. A total of 347 autologous arteriovenous fistulas (AVFs) were created in 294 patients. The mean age was 62.1 ± 14.7 years, and the majority (66%) of the patients was male. Mean follow-up of all 347 fistulas was 21.9 ± 21.6 months. During follow-up, failure occurred in 209 (60%) of the AVFs. A total of 133 of these failures were followed by a secondary intervention, of which 78 (59%) were endovascular interventions. Twenty-nine patients developed a third failure, and 25 of these patients underwent another intervention, of which 22 were percutaneous transluminal angioplasty for stenosis. Fifteen patients developed a fourth failure, and all of them underwent an intervention. One patient had 11 interventions. The 1- and 2-year primary patency rates were 46% and 36.8%, respectively. The 1- and 2-year primary assisted patency rates were 74.6% and 71.2%, respectively. The 1- and 2-year secondary patency rates were 79.2% and 77.8%, respectively. CONCLUSION: The primary patency rate of AVFs is disappointing. However, due to mostly endovascular secondary interventions, 2-year primary assisted and secondary patency rates of more than 70% can be obtained.


Arteriovenous Shunt, Surgical/adverse effects , Endovascular Procedures , Graft Occlusion, Vascular/therapy , Renal Dialysis , Upper Extremity/blood supply , Vascular Patency , Aged , Chi-Square Distribution , Female , Graft Occlusion, Vascular/diagnosis , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/physiopathology , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Netherlands , Patient Selection , Prospective Studies , Reoperation , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Failure
16.
Ann Surg Oncol ; 18(10): 2757-63, 2011 Oct.
Article En | MEDLINE | ID: mdl-21638093

BACKGROUND: Several clinical risk scores (CRSs) for the outcome of patients with colorectal liver metastases have been validated, but not in patients undergoing neoadjuvant chemotherapy. Therefore, this study evaluates the predictive value of these CRSs in this specific group. METHODS: Between January 2000 and December 2008, all patients undergoing a metastasectomy were analyzed and divided into two groups: 193 patients did not receive neoadjuvant chemotherapy (group A), and 159 patients received neoadjuvant chemotherapy (group B). In group B, the CRSs were calculated before and after administration of neoadjuvant chemotherapy. Results were evaluated by using the CRSs proposed by Nordlinger et al., Fong et al., Nagashima et al., and Konopke et al. RESULTS: In groups A and B, the overall median survival was 43 and 47 months, respectively (P = 0.648). In group A, all CRSs used were of statistically significant predictive value. Before administration of neoadjuvant chemotherapy, only the Nordlinger score was of predictive value. After administration of neoadjuvant chemotherapy, all CRSs were of predictive value again, except for the Konopke score. CONCLUSIONS: Traditional CRSs are not a reliable prognostic tool when used in patients before treatment with neoadjuvant chemotherapy. However, CRSs assessed after the administration of neoadjuvant chemotherapy are useful to predict prognosis.


Antineoplastic Agents/therapeutic use , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/pathology , Liver Neoplasms/drug therapy , Liver Neoplasms/secondary , Neoadjuvant Therapy , Adult , Aged , Aged, 80 and over , Chemotherapy, Adjuvant , Colorectal Neoplasms/surgery , Female , Follow-Up Studies , Humans , Liver Neoplasms/surgery , Male , Middle Aged , Prospective Studies , Retrospective Studies , Risk Factors , Survival Rate , Treatment Outcome
17.
World J Surg ; 35(3): 656-61, 2011 Mar.
Article En | MEDLINE | ID: mdl-21161655

BACKGROUND: The increased use of neoadjuvant chemotherapy and minimally invasive therapies for recurrence in patients with colorectal liver metastases (CLM) makes a surgical strategy to save as much liver volume as possible pivotal. In this study, we determined the difference in morbidity and mortality and the patterns of recurrence and survival in patients with CLM treated with anatomical (AR) and nonanatomical liver resection (NAR). METHODS: From January 2000 to June 2008, patients with CLM who underwent a resection were included and divided into two groups: patients who underwent AR, and patients who underwent NAR. Patients who underwent simultaneous radiofrequency ablation in addition to surgery and patients with extrahepatic metastasis were excluded. Patient, tumor, and treatment data, as well as disease-free and overall survival (OS) were compared. RESULTS: Eighty-eight patients (44%) received AR and 113 patients (56%) underwent NAR. NAR were performed for significant smaller metastases (3 vs. 4 cm, P < 0.001). The Clinical Risk Score did not differ between the groups. After NAR, patients received significantly less blood transfusions (20% vs. 36%, P = 0.012), and the hospital stay was significantly shorter (7 vs. 8 days, P < 0.001). There were no significant differences in complications, positive resection margins, or recurrence. For the total study group, estimated 5-year disease-free and OS was 31 and 44%, respectively, with no difference between the groups. CONCLUSIONS: Our study resulted in no significant difference in morbidity, mortality, recurrence rate, or survival according to resection type. NAR can be used as a save procedure to preserve liver parenchyma.


Catheter Ablation/methods , Colorectal Neoplasms/pathology , Hepatectomy/methods , Liver Neoplasms/secondary , Liver Neoplasms/surgery , Neoplasm Recurrence, Local/pathology , Adult , Aged , Aged, 80 and over , Catheter Ablation/mortality , Cohort Studies , Colorectal Neoplasms/mortality , Colorectal Neoplasms/surgery , Female , Follow-Up Studies , Hepatectomy/mortality , Humans , Liver/anatomy & histology , Liver/surgery , Liver Neoplasms/mortality , Male , Middle Aged , Neoplasm Invasiveness/pathology , Neoplasm Recurrence, Local/mortality , Neoplasm Staging , Reference Values , Retrospective Studies , Risk Assessment , Survival Analysis , Treatment Outcome
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