Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]
| Autor: | Johan S. Laméris, Thomas L. Bollen, Jean-Pierre E. N. Pierie, Marc G. Besselink, Hein G. Gooszen, Maarten S. van Leeuwen, Alexander F. Schaapherder, Erwin van der Harst, Robin Timmer, Sijbrand S. Hofker, Cees J. H. M. van Laarhoven, Hjalmar C. van Santvoort, Tom M. Karsten, Rutger J. Ploeg, Casper H.J. van Eijck, Esther C. J. Consten, Ben J.M. Witteman, Ingeborg van der Tweel, Erik Buskens, Camiel Rosman, Eric J. Hesselink, Marja A. Boermeester, Miguel A. Cuesta, Vincent B. Nieuwenhuijs, Lex P. J. Houdijk, Bert van Ramshorst, Harry van Goor, Ralph J. de Wit, Ernst Jan Spillenaar Bilgen, Dirk J. Gouma, Cornelis H. C. Dejong |
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| Přispěvatelé: | Other departments, AII - Amsterdam institute for Infection and Immunity, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, Radiology and Nuclear Medicine |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment lcsh:Surgery Therapeutic irrigation Video-Assisted Surgery/methods Postoperative Care/methods law.invention Randomized controlled trial law Intensive care Laparotomy Multicenter trial Laparotomy/methods medicine Clinical endpoint Humans Acute Necrotizing/surgery business.industry Mortality rate General Medicine lcsh:RD1-811 medicine.disease Surgery Pancreatitis Pancreatitis Acute Necrotizing/surgery Drainage Therapeutic Irrigation/methods business |
| Zdroj: | BMC Surgery, 6:6. BioMed Central Ltd. BMC surgery, 6. BioMed Central BMC Surgery, Vol 6, Iss 1, p 6 (2006) |
| ISSN: | 1471-2482 |
| Popis: | Background The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. Methods/design 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis. |
| Databáze: | OpenAIRE |
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