@article{e50ca8564bee4e1799db920d857c8f30,
title = "Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis",
abstract = "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 -euro6348, bias-corrected and accelerated 95% CI -euro26 386 to euro10 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.",
keywords = "endoscopy, acute pancreatitis, FLUID COLLECTIONS, MANAGEMENT, GUIDELINES, DRAINAGE",
author = "L. Boxhoorn and R.C. Verdonk and M.G. Besselink and M. Boermeester and T.L. Bollen and S.A.W. Bouwense and V.C. Cappendijk and W.L. Curvers and C.H. Dejong and {van Dijk}, S.M. and {van Dullemen}, H.M. and {van Eijck}, C.H.J. and {van Geenen}, E.J.M. and M. Hadithi and W.L. Hazen and P. Honkoop and {van Hooft}, J.E. and M.A.J.M. Jacobs and J.E.C. Kievits and M.P.M. Kop and E. Kouw and S.D. Kuiken and M. Ledeboer and V.B. Nieuwenhuijs and L.E. Perk and J.W. Poley and R. Quispel and {de Ridder}, R.J.J. and {van Santvoort}, H.C. and C.J.S. Weiland and M.W.J. Stommel and H.C. Timmerhuis and B. Witteman and D.S. Umans and N.G. Venneman and F.P. Vleggaar and {van Wanrooij}, R.L.J. and M.J. Bruno and P. Fockens and R.P. Voermans",
note = "Funding Information: An independent Data Safety Monitoring Board assessed patient recruitment and evaluated patient safety after consecutive enrolment of 15 patients. Complications were reported by treating clinicians to the coordinating investigator, who reported these events to the Dutch Central Committee for Research involving human subjects. An independent monitor performed clinical trial monitoring. The AXIOMA study was registered in the Netherlands Trial Registry (registry number NL6878). This investigator-initiated study was funded by an unrestricted grant of Boston Scientific Corporation and Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands. Patients or the public were not involved in the design, conduct, reporting or dissemination plans of this study. However, the patient association for pancreatic diseases, the {\textquoteleft}Alvleeskliervereniging{\textquoteright}, was actively involved in meetings of the Dutch Pancreatitis Study Group, including regarding the AXIOMA study and TENSION trial. The study is reported in accordance with the Strengthening the Reporting of Observational studies in Epidemiology guidelines.15 Publisher Copyright: {\textcopyright} ",
year = "2023",
month = jan,
doi = "10.1136/gutjnl-2021-325632",
language = "English",
volume = "72",
pages = "66--72",
journal = "Gut",
issn = "0017-5749",
publisher = "BMJ Publishing Group",
number = "1",
}