Summary Background Gemcitabine plus a platinum-based agent (eg, cisplatin or oxaliplatin) is the standard of care for advanced biliary cancers. We investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers. Methods In this non-comparative, open-label, randomised phase 2 trial, we recruited patients with locally advanced (non-resectable) or metastatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma and a WHO performance status of 0 or 1 from 18 hospitals across France and Germany. Eligible patients were randomly assigned (1:1) centrally with a minimisation procedure to first-line treatment with gemcitabine (1000 mg/m2) and oxaliplatin (100 mg/m2) with or without cetuximab (500 mg/m2), repeated every 2 weeks until disease progression or unacceptable toxicity. Randomisation was stratified by centre, primary site of disease, disease stage, and previous treatment with curative intent or adjuvant therapy. Investigators who assessed treatment response were not masked to group assignment. The primary endpoint was the proportion of patients who were progression-free at 4 months, analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00552149. Findings Between Oct 10, 2007, and Dec 18, 2009, 76 patients were assigned to chemotherapy plus cetuximab and 74 to chemotherapy alone. 48 (63%; 95% CI 52–74) patients assigned to chemotherapy plus cetuximab and 40 (54%; 43–65) assigned to chemotherapy alone were progression-free at 4 months. Median progression-free survival was 6·1 months (95% CI 5·1–7·6) in the chemotherapy plus cetuximab group and 5·5 months (3·7–6·6) in the chemotherapy alone group. Median overall survival was 11·0 months (9·1–13·7) in the chemotherapy plus cetuximab group and 12·4 months (8·6–16·0) in the chemotherapy alone group. The most common grade 3–4 adverse events were peripheral neuropathy (in 18 [24%] of 76 patients who received chemotherapy plus cetuximab vs ten [15%] of 68 who received chemotherapy alone), neutropenia (17 [22%] vs 11 [16%]), and increased aminotransferase concentrations (17 [22%] vs ten [15%]). 70 serious adverse events were reported in 39 (51%) of 76 patients who received chemotherapy plus cetuximab (34 events in 19 [25%] patients were treatment-related), whereas 41 serious adverse events were reported in 25 (35%) of 71 patients who received chemotherapy alone (20 events in 12 [17%] patients were treatment-related). One patient died of atypical pneumonia related to treatment in the chemotherapy alone group. Interpretation The addition of cetuximab to gemcitabine and oxaliplatin did not seem to enhance the activity of chemotherapy in patients with advanced biliary cancer, although it was well tolerated. Gemcitabine and platinum-based combination should remain the standard treatment option.

Study Design:Expert opinion.Objectives:Osteoporotic vertebral fractures are of increasing medical importance. For an adequate treatment strategy, an easy and reliable classification is needed.Methods:The working group “Osteoporotic Fractures” of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU) has developed a classification system (OF classification) for osteoporotic thoracolumbar fractures. The consensus decision followed an established pathway including review of the current literature.Results:The OF classification consists of 5 groups: OF 1, no vertebral deformation (vertebral edema); OF 2, deformation with no or minor (<1/5) involvement of the posterior wall; OF 3, deformation with distinct involvement (>1/5) of the posterior wall; OF 4, loss of integrity of the vertebral frame or vertebral body collapse or pincer-type fracture; OF 5, injuries with distraction or rotation. The interobserver reliability was substantial (κ = .63).Conclusions:The proposed OF classification is easy to use and provides superior clinical differentiation of the typical osteoporotic fracture morphologies.

The recorded results show that the full-endoscopic interlaminar bilateral decompression with unilateral approach is a sufficient and safe supplement and alternative to conventional procedures when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention.

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IntroductionThe impact of anemia on functional outcome and mortality in patients suffering from non-traumatic intracerebral hemorrhage (ICH) has not been investigated. Here, we assessed the relationship between hemoglobin (HB) levels and clinical outcome after ICH.MethodsOne hundred and ninety six patients suffering from supratentorial, non-traumatic ICH were extracted from our local stroke database (June 2004 to June 2006). Clinical and radiologic computed tomography data, HB levels on admission, mean HB values and nadir during hospital stay were recorded. Outcome was assessed at discharge and 3 months using the modified Rankin score (mRS).ResultsForty six (23.5%) patients achieved a favorable functional outcome (mRS ≤ 3) and 150 (76.5%) had poor outcome (mRS 4 - 6) at discharge. Patients with poor functional outcome had a lower mean HB (12.3 versus 13.7 g/dl, P < 0.001) and nadir HB (11.5 versus 13.0 g/dl, P < 0.001). Ten patients (5.1%) received red blood cell (RBC) transfusions. In a multivariate logistic regression model, the mean HB was an independent predictor for poor functional outcome at three months (odds ratio (OR) 0.73, 95% confidence interval (CI) 0.58-0.92, P = 0.007), along with National Institute of Health Stroke Scale (NIHSS) at admission (OR 1.17, 95% CI 1.11 - 1.24, P < 0.001), and age (OR 1.08, 95% CI 1.04 - 1.12, P < 0.001).ConclusionsWe report an association between low HB and poor outcome in patients with non-traumatic, supratentorial ICH. While a causal relationship could not be proven, previous experimental studies and studies in brain injured patients provide evidence for detrimental effects of anemia on brain metabolism. However, the potential risk of anemia must be balanced against the risk of harm from red blood cell infusion.

OBJECTIVESurgery for thoracic disc herniation and spinal canal stenosis is comparatively rare and often challenging. Individual planning and various surgical techniques and approaches are required. The key factors for selecting the technique and approach are anatomical location, consistency of the pathology, general condition of the patient, and the surgeon’s experience. The objective of the study was to evaluate the technical implementation and outcomes of a full-endoscopic uniportal technique via the interlaminar, extraforaminal, or transthoracic retropleural approach in patients with symptomatic disc herniation and stenosis of the thoracic spine, taking specific advantages and disadvantages and literature into consideration.METHODSBetween 2009 and 2015, decompression was performed in 55 patients with thoracic disc herniation or stenosis using a full-endoscopic uniportal technique via an interlaminar, extraforaminal, or transthoracic retropleural approach. Imaging and clinical data were collected during follow-up examinations for 18 months.RESULTSSufficient decompression was achieved in the full-endoscopic uniportal technique. One patient required revision due to secondary bleeding, and another exhibited persistent deterioration on myelopathy. No other serious complications were observed. All but one patient experienced regression or improvement of their symptoms.CONCLUSIONSThe full-endoscopic uniportal technique with an interlaminar, extraforaminal, or transthoracic retropleural approach was found to be a sufficient and minimally invasive method. To cover the entire range of thoracic disc herniations and stenosis within the criteria named, all full-endoscopic approaches are required.

To accurately identify lumbosacral transitional vertebrae and disease location, cervicothoracic sagittal scout images were obtained in addition to the standard images used in magnetic resonance imaging studies of the lumbar spine, and vertebrae were counted down from C-2 rather than up from L-5. In 200 patients, these techniques revealed 24 transitional vertebrae (15 cases of sacralization of L-5 and nine cases of lumbarization of S-1).

The therapy for congenital hand malformations, especially in symbrachydactyly and constriction ring syndromes, is challenging. Between 1975 and 1995, 20 children with congenital hand deformities underwent reconstruction by 56 nonvascularized free toe phalanx transfers. The average age at initial surgery was 4.8 (range, 0.5 to 22) years. Retrospectively, the children were examined after an average of 3.5 (range, 1.5 to 17.6) years for function of the hand, transplanted phalanx growth, assessment for the epiphyseal plate, and assessment for psychologic performance with their parents. Donor-site morbidity was determined according to measured growth deficit, observing the child's gait, and toe function. In the younger patients (up to 1.5 years), the grafts were well tolerated and showed good growth and only few resorptions. In the age group from 1.5 to 4 years, the grafts showed no growth. In the age group older than 4 years, the grafts were mostly resorbed. The clinical reexamination revealed in most cases only passive motion in the joints, but the function of the hand was improved, with only few problems of the donor site. Most patients and their parents reported a positive effect of the phalanx transfer.