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  • 1
    Language: English
    In: The lancet oncology, 2013, Vol.14 (3), p.210-218
    Description: Summary Background Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. Methods A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov , number NCT00297791. Findings The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p〈0·0001); however, laparoscopic procedures took longer (240 min [184–300] vs 188 min [150–240]; p〈0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0–3·0] vs 3·0 days [2·0–4·0]; p〈0·0001) and hospital stay was shorter (8·0 days [6·0–13·0] vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (〈2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0–4·8] vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. Interpretation In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013. Funding Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.
    Subject(s): Adult ; Aged ; Aged, 80 and over ; Colorectal cancer ; Europe ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Laparoscopic surgery ; Laparoscopy ; Laparoscopy - methods ; Lymph Nodes - surgery ; Male ; Middle Aged ; Neoplasm Recurrence, Local - surgery ; Neoplasm Staging ; Rectal Neoplasms - pathology ; Rectal Neoplasms - radiotherapy ; Rectal Neoplasms - surgery ; Treatment Outcome
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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  • 2
    Language: English
    In: The Lancet (British edition), 2012, Vol.379 (9829), p.1887-1892
    Description: Summary Background Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy. Methods We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18–75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Findings We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12–0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16–0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage. Interpretation These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer. Funding Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre.
    Subject(s): Abdomen ; Abridged Index Medicus ; Adolescent ; Adult ; Aged ; Bias ; Biological and medical sciences ; Cancer ; Care and treatment ; Diagnosis ; Esophageal cancer ; Esophageal Neoplasms - surgery ; Esophagectomy - methods ; Esophagogastric Junction - surgery ; Esophagoscopy - methods ; Esophagus ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; General aspects ; Health aspects ; Hospitals ; Humans ; Internal Medicine ; Intubation ; Length of Stay ; Lung Diseases - etiology ; Male ; Medical sciences ; Middle Aged ; Mortality ; Ostomy ; Postoperative Complications - etiology ; Quality of Life ; Respiratory Tract Infections - etiology ; Surgery ; Treatment Outcome ; Tumors ; Young Adult
    ISSN: 0140-6736
    E-ISSN: 1474-547X
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
    Source: Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)
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  • 3
    Language: English
    In: The lancet oncology, 2015, Vol.16 (9), p.1090-1098
    Description: Summary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months' follow-up. In this Article, we report the long-term results after a minimum follow-up of 5 years. Methods Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2–3N0–1M0, according to the TNM cancer staging system, sixth edition) were randomly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by surgery, or surgery alone. The primary endpoint was overall survival, analysed by intention-to-treat. No adverse event data were collected beyond those noted in the initial report of the trial. This trial is registered with the Netherlands Trial Register, number NTR487, and has been completed. Findings Between March 30, 2004, and Dec 2, 2008, 368 patients from eight participating centres (five academic centres and three large non-academic teaching hospitals) in the Netherlands were enrolled into this study and randomly assigned to the two treatment groups: 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone. Two patients in the neoadjuvant chemoradiotherapy group withdrew consent, so a total of 366 patients were analysed (178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group). Of 171 patients who received any neoadjuvant chemoradiotherapy in this group, 162 (95%) were able to complete the entire neoadjuvant chemoradiotherapy regimen. After a median follow-up for surviving patients of 84·1 months (range 61·1–116·8, IQR 70·7–96·6), median overall survival was 48·6 months (95% CI 32·1–65·1) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months (14·2–33·7) in the surgery alone group (HR 0·68 [95% CI 0·53–0·88]; log-rank p=0·003). Median overall survival for patients with squamous cell carcinomas was 81·6 months (95% CI 47·2–116·0) in the neoadjuvant chemoradiotherapy plus surgery group and 21·1 months (15·4–26·7) in the surgery alone group (HR 0·48 [95% CI 0·28–0·83]; log-rank p=0·008); for patients with adenocarcinomas, it was 43·2 months (24·9–61·4) in the neoadjuvant chemoradiotherapy plus surgery group and 27·1 months (13·0–41·2) in the surgery alone group (HR 0·73 [95% CI 0·55–0·98]; log-rank p=0·038). Interpretation Long-term follow-up confirms the overall survival benefits for neoadjuvant chemoradiotherapy when added to surgery in patients with resectable oesophageal or oesophagogastric junctional cancer. This improvement is clinically relevant for both squamous cell carcinoma and adenocarcinoma subtypes. Therefore, neoadjuvant chemoradiotherapy according to the CROSS trial followed by surgical resection should be regarded as a standard of care for patients with resectable locally advanced oesophageal or oesophagogastric junctional cancer. Funding Dutch Cancer Foundation (KWF Kankerbestrijding).
    Subject(s): Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Cancer therapies ; Carboplatin - administration & dosage ; Cervical cancer ; Chemoradiotherapy ; Chemotherapy ; Disease-Free Survival ; Endoscopy ; Esophageal cancer ; Esophageal Neoplasms - drug therapy ; Esophageal Neoplasms - pathology ; Esophageal Neoplasms - radiotherapy ; Esophageal Neoplasms - surgery ; Esophagogastric Junction - drug effects ; Esophagogastric Junction - pathology ; Esophagogastric Junction - radiation effects ; Esophagogastric Junction - surgery ; Female ; Fluorouracil - administration & dosage ; Hematology, Oncology and Palliative Medicine ; Histology ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Mortality ; Neoplasm Staging ; Paclitaxel - administration & dosage ; Radiation therapy ; Squamous cell carcinoma ; Surgery ; Ultrasonic imaging
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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  • 4
    Language: English
    In: The Lancet (British edition), 2008, Vol.371 (9613), p.651-659
    Description: Summary Background Infectious complications and associated mortality are a major concern in acute pancreatitis. Enteral administration of probiotics could prevent infectious complications, but convincing evidence is scarce. Our aim was to assess the effects of probiotic prophylaxis in patients with predicted severe acute pancreatitis. Methods In this multicentre randomised, double-blind, placebo-controlled trial, 298 patients with predicted severe acute pancreatitis (Acute Physiology and Chronic Health Evaluation [APACHE II] score ≥8, Imrie score ≥3, or C-reactive protein 〉150 mg/L) were randomly assigned within 72 h of onset of symptoms to receive a multispecies probiotic preparation (n=153) or placebo (n=145), administered enterally twice daily for 28 days. The primary endpoint was the composite of infectious complications—ie, infected pancreatic necrosis, bacteraemia, pneumonia, urosepsis, or infected ascites—during admission and 90-day follow-up. Analyses were by intention to treat. This study is registered, number ISRCTN38327949. Findings One person in each group was excluded from analyses because of incorrect diagnoses of pancreatitis; thus, 152 individuals in the probiotics group and 144 in the placebo group were analysed. Groups were much the same at baseline in terms of patients' characteristics and disease severity. Infectious complications occurred in 46 (30%) patients in the probiotics group and 41 (28%) of those in the placebo group (relative risk 1·06, 95% CI 0·75–1·51). 24 (16%) patients in the probiotics group died, compared with nine (6%) in the placebo group (relative risk 2·53, 95% CI 1·22–5·25). Nine patients in the probiotics group developed bowel ischaemia (eight with fatal outcome), compared with none in the placebo group (p=0·004). Interpretation In patients with predicted severe acute pancreatitis, probiotic prophylaxis with this combination of probiotic strains did not reduce the risk of infectious complications and was associated with an increased risk of mortality. Probiotic prophylaxis should therefore not be administered in this category of patients.
    Subject(s): Abridged Index Medicus ; Acute Disease ; Adult ; Aged ; Aged, 80 and over ; Analysis ; Antibiotics ; Bacteria ; Clinical medicine ; Clinical trials ; Double-Blind Method ; Enteral nutrition ; Epidemiology ; Female ; Health aspects ; Humans ; Internal Medicine ; Logistic Models ; Male ; Medical colleges ; Medical research ; Medicine, Experimental ; Middle Aged ; Mortality ; Netherlands ; Pancreas ; Pancreatitis ; Pancreatitis - complications ; Pancreatitis - prevention & control ; Patients ; Placebos ; Prevention ; Probiotics ; Probiotics - therapeutic use ; Statistics, Nonparametric ; Treatment Outcome
    ISSN: 0140-6736
    E-ISSN: 1474-547X
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
    Source: Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)
    Library Location Call Number Volume/Issue/Year Availability
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