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]
<p>Abstract</p> <p>Background</p> <p>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 lapar...
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| Format: | Article |
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BMC
2006-04-01
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| Series: | BMC Surgery |
| Online Access: | http://www.biomedcentral.com/1471-2482/6/6 |
| _version_ | 1811244145919918080 |
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| author | Houdijk Lex PJ Hesselink Eric J van der Harst Erwin Gouma Dirk J Consten Esther CJ Cuesta Miguel A Schaapherder Alexander FM van Ramshorst Bert Ploeg Rutger J van Leeuwen Maarten S Lameris Johan S Hofker Sijbrand S van Goor Harry van Eijck Casper HJ Dejong Cornelis HC Buskens Erik Bollen Thomas L Boermeester Marja A Nieuwenhuijs Vincent B van Santvoort Hjalmar C Besselink Marc GH Karsten Tom M van Laarhoven Cees JHM Pierie Jean-Pierre EN Rosman Camiel Bilgen Ernst Timmer Robin van der Tweel Ingeborg de Wit Ralph J Witteman Ben JM Gooszen Hein G |
| author_facet | Houdijk Lex PJ Hesselink Eric J van der Harst Erwin Gouma Dirk J Consten Esther CJ Cuesta Miguel A Schaapherder Alexander FM van Ramshorst Bert Ploeg Rutger J van Leeuwen Maarten S Lameris Johan S Hofker Sijbrand S van Goor Harry van Eijck Casper HJ Dejong Cornelis HC Buskens Erik Bollen Thomas L Boermeester Marja A Nieuwenhuijs Vincent B van Santvoort Hjalmar C Besselink Marc GH Karsten Tom M van Laarhoven Cees JHM Pierie Jean-Pierre EN Rosman Camiel Bilgen Ernst Timmer Robin van der Tweel Ingeborg de Wit Ralph J Witteman Ben JM Gooszen Hein G |
| author_sort | Houdijk Lex PJ |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> |
| first_indexed | 2024-04-12T14:20:46Z |
| format | Article |
| id | doaj.art-639cf3ad057147099e4808c30c7ea7ec |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-04-12T14:20:46Z |
| publishDate | 2006-04-01 |
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| series | BMC Surgery |
| spelling | doaj.art-639cf3ad057147099e4808c30c7ea7ec2022-12-22T03:29:36ZengBMCBMC Surgery1471-24822006-04-0161610.1186/1471-2482-6-6Minimally 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]Houdijk Lex PJHesselink Eric Jvan der Harst ErwinGouma Dirk JConsten Esther CJCuesta Miguel ASchaapherder Alexander FMvan Ramshorst BertPloeg Rutger Jvan Leeuwen Maarten SLameris Johan SHofker Sijbrand Svan Goor Harryvan Eijck Casper HJDejong Cornelis HCBuskens ErikBollen Thomas LBoermeester Marja ANieuwenhuijs Vincent Bvan Santvoort Hjalmar CBesselink Marc GHKarsten Tom Mvan Laarhoven Cees JHMPierie Jean-Pierre ENRosman CamielBilgen ErnstTimmer Robinvan der Tweel Ingeborgde Wit Ralph JWitteman Ben JMGooszen Hein G<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p>http://www.biomedcentral.com/1471-2482/6/6 |
| spellingShingle | Houdijk Lex PJ Hesselink Eric J van der Harst Erwin Gouma Dirk J Consten Esther CJ Cuesta Miguel A Schaapherder Alexander FM van Ramshorst Bert Ploeg Rutger J van Leeuwen Maarten S Lameris Johan S Hofker Sijbrand S van Goor Harry van Eijck Casper HJ Dejong Cornelis HC Buskens Erik Bollen Thomas L Boermeester Marja A Nieuwenhuijs Vincent B van Santvoort Hjalmar C Besselink Marc GH Karsten Tom M van Laarhoven Cees JHM Pierie Jean-Pierre EN Rosman Camiel Bilgen Ernst Timmer Robin van der Tweel Ingeborg de Wit Ralph J Witteman Ben JM Gooszen Hein G 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] BMC Surgery |
| title | 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] |
| title_full | 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] |
| title_fullStr | 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] |
| title_full_unstemmed | 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] |
| title_short | 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] |
| title_sort | 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 |
| url | http://www.biomedcentral.com/1471-2482/6/6 |
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