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 style="text-align:justify;"> <b>Background:</b> 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 necrosec...
| Główni autorzy: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Język: | English |
| Wydane: |
BioMed Central
2006
|
| _version_ | 1826256701309845504 |
|---|---|
| author | Besselink, M Van Santvoort, H Nieuwenhuijs, V Boermeester, M Bollen, T Buskens, E Dejong, C Van Eijck, C Van Goor, H Hofker, S Lameris, J Van Leeuwen, MS Ploeg, R Van Ramshorst, B Schaapherder, A Cuesta, M Consten, E Gouma, D Van Der Harst, E Hesselink, E Houdijk, L Karsten, T Van Laarhoven, C Pierie, J Rosman, C Bilgen, E Timmer, R Van Der Tweel, I De Wit, R Witteman, B Gooszen, H |
| author_facet | Besselink, M Van Santvoort, H Nieuwenhuijs, V Boermeester, M Bollen, T Buskens, E Dejong, C Van Eijck, C Van Goor, H Hofker, S Lameris, J Van Leeuwen, MS Ploeg, R Van Ramshorst, B Schaapherder, A Cuesta, M Consten, E Gouma, D Van Der Harst, E Hesselink, E Houdijk, L Karsten, T Van Laarhoven, C Pierie, J Rosman, C Bilgen, E Timmer, R Van Der Tweel, I De Wit, R Witteman, B Gooszen, H |
| author_sort | Besselink, M |
| collection | OXFORD |
| description | <p style="text-align:justify;"> <b>Background:</b> 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.<br/><br/> <b>Methods/design:</b> 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.<br/><br/> <b>Discussion:</b> 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 | 2024-03-06T18:06:25Z |
| format | Journal article |
| id | oxford-uuid:018edd6a-3f8f-42e5-bffc-7c64d3f6f9a0 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T18:06:25Z |
| publishDate | 2006 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:018edd6a-3f8f-42e5-bffc-7c64d3f6f9a02022-03-26T08:35:46ZMinimally 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]Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:018edd6a-3f8f-42e5-bffc-7c64d3f6f9a0EnglishSymplectic Elements at OxfordBioMed Central2006Besselink, MVan Santvoort, HNieuwenhuijs, VBoermeester, MBollen, TBuskens, EDejong, CVan Eijck, CVan Goor, HHofker, SLameris, JVan Leeuwen, MSPloeg, RVan Ramshorst, BSchaapherder, ACuesta, MConsten, EGouma, DVan Der Harst, EHesselink, EHoudijk, LKarsten, TVan Laarhoven, CPierie, JRosman, CBilgen, ETimmer, RVan Der Tweel, IDe Wit, RWitteman, BGooszen, H <p style="text-align:justify;"> <b>Background:</b> 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.<br/><br/> <b>Methods/design:</b> 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.<br/><br/> <b>Discussion:</b> 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> |
| spellingShingle | Besselink, M Van Santvoort, H Nieuwenhuijs, V Boermeester, M Bollen, T Buskens, E Dejong, C Van Eijck, C Van Goor, H Hofker, S Lameris, J Van Leeuwen, MS Ploeg, R Van Ramshorst, B Schaapherder, A Cuesta, M Consten, E Gouma, D Van Der Harst, E Hesselink, E Houdijk, L Karsten, T Van Laarhoven, C Pierie, J Rosman, C Bilgen, E Timmer, R Van Der Tweel, I De Wit, R Witteman, B Gooszen, H 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 | 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 |
| work_keys_str_mv | AT besselinkm minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vansantvoorth minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT nieuwenhuijsv minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT boermeesterm minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT bollent minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT buskense minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT dejongc minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vaneijckc minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vangoorh minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT hofkers minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT lamerisj minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vanleeuwenms minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT ploegr minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vanramshorstb minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT schaapherdera minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT cuestam minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT constene minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT goumad minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vanderharste minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT hesselinke minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT houdijkl minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT karstent minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vanlaarhovenc minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT pieriej minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT rosmanc minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT bilgene minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT timmerr minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT vandertweeli minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT dewitr minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT wittemanb minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 AT gooszenh minimallyinvasivestepupapproachversusmaximalnecrosectomyinpatientswithacutenecrotisingpancreatitispantertrialdesignandrationaleofarandomisedcontrolledmulticentertrialisrctn13975868 |