Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis.

OBJECTIVE: Lumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited. DESIGN: Patients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs. RESULTS: A total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention-5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference -€6348, bias-corrected and accelerated 95% CI -€26 386 to €10 121). CONCLUSION: Our comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.

Test-retest, inter-assessor and intra-assessor reliability of the modified Touwen examination.

Interest in the Touwen examination (1979) for the assessment of minor neurological dysfunction (MND) is growing. However, information on psychometric properties of this assessment is scarce. Therefore the present study aimed at assessing the test's test-retest, inter- and intra-assessor reliability. Eleven boys and 14 girls, visiting a mainstream school, aged 4-12 years, were tested neurologically by 3 investigators. Inter- and intra-assessor reliability were based on videotapes of the assessments. To determine test-retest reliability children were re-assessed after about 1 month. The various forms of reliability were calculated for neurological classification (normal, simple MND, complex MND), clusters of dysfunction and single items. Twelve girls and 7 boys showed a normal neurological condition; 2 girls and 1 boy were classified as having simple MND and 3 boys as having complex MND. The 3 forms of reliability for neurological classification were good (kappa=0.71-0.83). Reliability for the majority of cluster scores was good. Test-retest agreement was moderate for the clusters reflexes and coordination and poor for fine manipulation; inter-assessor agreement was moderate for the clusters coordination and fine manipulation; intra-assessor agreement moderate for fine manipulation. Reliability for the majority of items was good. In conclusion, the Touwen examination has a moderate to good reliability when applied in a relatively healthy population. Whether reliability is similarly good in populations of children with minor developmental disorders has to be determined.