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 [ISRCTN38327949]

被引：99

作者：

Besselink M.G.H. ^{[1
]}

Van Santvoort H.C. ^{[1
]}

Nieuwenhuijs V.B. ^{[1
]}

Boermeester M.A. ^{[2
]}

Bollen T.L. ^{[3
]}

Buskens E. ^{[4
]}

Dejong C.H.C. ^{[5
]}

Van Eijck C.H.J. ^{[6
]}

Van Goor H. ^{[7
]}

Hofker S.S. ^{[8
]}

Lameris J.S. ^{[9
]}

Van Leeuwen M.S.

Ploeg R.J. ^{[8
]}

Van Ramshorst B. ^{[10
]}

Schaapherder A.F.M. ^{[11
]}

Cuesta M.A. ^{[12
]}

Consten E.C.J. ^{[13
]}

Gouma D.J. ^{[2
]}

Van Der Harst E. ^{[14
]}

Hesselink E.J. ^{[15
]}

Houdijk L.P.J. ^{[16
]}

Karsten T.M. ^{[17
]}

Van Laarhoven C.J.H.M. ^{[18
]}

Pierie J.-P.E.N. ^{[19
]}

Rosman C. ^{[20
]}

Bilgen E.J.S. ^{[21
]}

Timmer R. ^{[22
]}

Van Der Tweel I. ^{[23
]}

De Wit R.J. ^{[24
]}

Witteman B.J.M. ^{[25
]}

Gooszen H.G. ^{[1
]}

机构：

[1] Department of Surgery, University Medical Center Utrecht

[2] Department of Surgery, Academic Medical Center Amsterdam

[3] Department of Radiology, St. Antonius Hospital Nieuwegein

[4] Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht

[5] Department of Surgery, University Hospital Maastricht, NUTRIM Institute

[6] Department of Surgery, Erasmus Medical Center Rotterdam

[7] Department of Surgery, Radboud University Nijmegen Medical Centre

[8] Department of Surgery, University Medical Center Groningen

[9] Department of Radiology, Academic Medical Center Amsterdam

[10] Department of Surgery, St. Antonius Hospital Nieuwegein

[11] Department of Surgery, Leiden University Medical Center

[12] Department of Surgery, VU Medical Center Amsterdam

[13] Department of Surgery, Meander Medical Center Amersfoort

[14] Department of Surgery, Medical Center Rijnmond Zuid Rotterdam

[15] Department of Surgery, Gelre Hospitals Apeldoorn

[16] Department of Surgery, Medical Center Alkmaar

[17] Department of Surgery, Reinier de Graaf Group Delft

[18] Department of Surgery, St. Elisabeth Hospital Tilburg

[19] Department of Surgery, Medical Center Leeuwarden

[20] Department of Surgery, Canisius Wilhelmina Hospital Nijmegen

[21] Department of Surgery, Rijnstate Hospital Arnhem

[22] Department of Gastroenterology, St. Antonius Hospital Nieuwegein

[23] Utrecht University, Centre for Biostatistics

[24] Department of Surgery, Medical Spectrum Twente, Enschede

[25] Department of Gastroenterology and Hepatology, Gelderse Vallei Ede

来源：

BMC Surgery | / 6卷 / 1期

关键词：

Pancreatitis; Acute Pancreatitis; Pancreatic Necrosis; Abdominal Compartment Syndrome; Necrotizing Pancreatitis;

D O I：

10.1186/1471-2482-6-6

中图分类号：

学科分类号：

摘要：

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. © 2006 Besselink et al; licensee BioMed Central Ltd.

引用

共 26 条

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