Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

Contains fulltext : 69534.pdf (publisher's version ) (Open Access)BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150

Facies analyses, chronostratigraphy and paleoenvironemental reconstructions of jurassic to cetaceous sequence of the Congo basin

International audienceThe Congo Basin is characterized by an extensive and relatively thick (ca. 1 km) succession of Jurassic-Cretaceous sedimentary sequences that preserves a unique record of the tectonic and climatic evolution of central Africa during the main period of break-up of Gondwana and the emergence of the Indian and South Atlantic Oceans. New facies analysis and detailed correlations of these ‘Congo’ sequences are described from field observations in the southwestern Congo Basin and by re-logging cores and well logs from four deep boreholes drilled in the center of the basin in the 1950s and 1970s. The lowermost Upper Jurassic sequence (the Stanleyville Group) records a short marine incursion of the proto-Indian Ocean into the northern Congo Basin, and is in turn overlain to the south by widespread aeolian dune deposits (the Lower Kwango Group), which correlate well with other Upper Jurassic to Lower Cretaceous aeolian sequences in Namibia and eastern Brazil, attesting to a giant ‘Sahara-like’ paleo-desert across central West Gondwana, just before the separation of Africa from South America. U-Pb detrital zircons geochronology from this aeolian sequence in the Congo Basin dates mid-Silurian (ca. 430 Ma), Permian-Triassic (ca. 240 and 290 Ma) and Jurassic (ca. 190 Ma) magmatic zircons, here proposed to have been sourced from abundant volcanic activity along the proto-Andes, in southernmost Gondwana. Two successive middle Cretaceous lacustrine sequences in the center of the Congo Basin (the Loia and Bokungu Groups), first analcime-rich and episodically anoxic, and then more carbonated, are interpreted to record an episode of basin stagnation following the eruption of the Paraná-Etendeka Large Igneous Province and a subsequent hot/humid climate maximum during the opening of the South Atlantic Ocean. Late Cretaceous sedimentation in the Congo Basin terminated with fluvial sediments (the Upper Kwango Group) suggesting marginal uplifts during the Kalahari epeirogeny. The top of these sequences is truncated by a regional Cenozoic peneplanation surface

Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE):design and rationale of a randomized trial

<p>Background: In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis.</p><p>Methods/design: The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (>= 5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (>= 4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%).</p><p>Discussion: The ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice.</p>

New regioanal correlations between the Congo, Paranà and Cape-Karoo basins of Southwest gondwana

International audienc