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]
详细信息 查看全文
- 作者：Marc GH Besselink (1)
Hjalmar C van Santvoort (1)
Vincent B Nieuwenhuijs (1)
Marja A Boermeester (2)
Thomas L Bollen (3)
Erik Buskens (4)
Cornelis HC Dejong (5)
Casper HJ van Eijck (6)
Harry van Goor (7)
Sijbrand S Hofker (8)
Johan S Lameris (9)
Maarten S van Leeuwen
Rutger J Ploeg (8)
Bert van Ramshorst (10)
Alexander FM Schaapherder (11)
Miguel A Cuesta (12)
Esther CJ Consten (13)
Dirk J Gouma (2)
Erwin van der Harst (14)
Eric J Hesselink (15)
Lex PJ Houdijk (16)
Tom M Karsten (17)
Cees JHM van Laarhoven (18)
Jean-Pierre EN Pierie (19)
Camiel Rosman (20)
Ernst Jan Spillenaar Bilgen (21)
Robin Timmer (22)
Ingeborg van der Tweel (23)
Ralph J de Wit (24)
Ben JM Witteman (25)
Hein G Gooszen (1) - 刊名：BMC Surgery
- 出版年：2006
- 出版时间：December 2006
- 年：2006
- 卷：6
- 期：1
- 全文大小：556KB
- 参考文献：1. Bradley EL III: A clinically based classification system for acute pancreatitis. Summary of the International Symposium on Acute Pancreatitis, Atlanta, Ga, September 11 through 13, 1992. / Arch Surg 1993, 128:586鈥?90.
2. UK guidelines for the management of acute pancreatitis / Gut 2005,54(Suppl 3):iii1-iii9.
3. Toouli J, Brooke-Smith M, Bassi C, Carr-Locke D, Telford J, Freeny P, / et al.: Guidelines for the management of acute pancreatitis. / J Gastroenterol Hepatol 2002,17(Suppl 1):15鈥?9. CrossRef
4. Uhl W, Warshaw A, Imrie C, Bassi C, McKay CJ, Lankisch PG, / et al.: IAP Guidelines for the Surgical Management of Acute Pancreatitis. / Pancreatology 2002, 2:565鈥?73. CrossRef
5. Mier J, Luque-de Le贸n E, Castillo A, Robledo F, Blanco R: Early versus late necrosectomy in severe necrotizing pancreatitis. / Am J Surg 1997, 173:71鈥?5. CrossRef
6. Nieuwenhuijs VB, Besselink MG, van Minnen LP, Gooszen HG: Surgical management of acute necrotizing pancreatitis: a 13-year experience and a systematic review. / Scand J Gastroenterol Suppl 2003, 111鈥?16.
7. Werner J, Feuerbach S, Uhl W, Buchler MW: Management of acute pancreatitis: from surgery to interventional intensive care. / Gut 2005, 54:426鈥?36. CrossRef
8. Besselink MGH, De Bruijn MT, Rutten JP, Boermeester MA, Hofker HS, Gooszen HG, Dutch Acute Pancreatitis Study Group: Surgical intervention in patients with necrotizing pancreatitis. / Br J Surg 2006,93(5):593鈥?. CrossRef
9. Carter CR, McKay CJ, Imrie CW: Percutaneous necrosectomy and sinus tract endoscopy in the management of infected pancreatic necrosis: an initial experience. / Ann Surg 2000, 232:175鈥?80. CrossRef
10. Connor S, Ghaneh P, Raraty M, Sutton R, Rosso E, Garvey CJ, / et al.: Minimally invasive retroperitoneal pancreatic necrosectomy. / Dig Surg 2003, 20:270鈥?77. CrossRef
11. Horvath KD, Kao LS, Wherry KL, Pellegrini CA, Sinanan MN: A technique for laparoscopic-assisted percutaneous drainage of infected pancreatic necrosis and pancreatic abscess. / Surg Endosc 2001, 15:1221鈥?225. CrossRef
12. Echenique AM, Sleeman D, Yrizarry J, Scagnelli T, Guerra-JJ J, Casillas VJ, / et al.: Percutaneous catheter-directed debridement of infected pancreatic necrosis: results in 20 patients. / J Vasc Interv Radiol 1998, 9:565鈥?71. CrossRef
13. Freeny PC, Hauptmann E, Althaus SJ, Traverso LW, Sinanan M: Percutaneous CT-guided catheter drainage of infected acute necrotizing pancreatitis: techniques and results. / Am J Roentgenol 1998, 170:969鈥?75.
14. Gouzi JL, Bloom E, Julio C, Labbe F, Sans N, el Rassi Z, / et al.: [Percutaneous drainage of infected pancreatic necrosis: an alternative to surgery]. Drainage percutane des necroses pancreatiques infectees: alternative a la chirurgie. / Chirurgie 1999, 124:31鈥?7. CrossRef
15. Baron TH, Thaggard WG, Morgan DE, Stanley RJ: Endoscopic therapy for organized pancreatic necrosis. / Gastroenterology 1996, 111:755鈥?64. CrossRef
16. Seewald S, Groth S, Omar S, Imazu H, Seitz U, de Weerth A, / et al.: Aggressive endoscopic therapy for pancreatic necrosis and pancreatic abscess: a new safe and effective treatment algorithm (videos). / Gastrointest Endosc 2005, 62:92鈥?00. CrossRef
17. Mueller PR: Percutaneous drainage of pancreatic necrosis: is it ecstasy or agony? / AJR Am J Roentgenol 1998, 170:976鈥?77.
18. Whitehead J: / The design and analysis of sequential clinical trials / Rev. 2 Edition Chicester: J. Wiley&Sons 1997.
19. Marik PE, Zaloga GP: Meta-analysis of parenteral nutrition versus enteral nutrition in patients with acute pancreatitis. / BMJ 2004, 328:1407. CrossRef
20. Beger HG, Buchler M, Bittner R, Block S, Nevalainen T, Roscher R: Necrosectomy and postoperative local lavage in necrotizing pancreatitis. / Br J Surg 1988, 75:207鈥?12. CrossRef
21. Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, / et al.: Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. / Crit Care Med 1998, 26:1793鈥?800.
22. Vincent JL, Moreno R, Takala J, Willatts S, de Mendonca A, Bruining H, / et al.: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. / Intensive Care Med 1996, 22:707鈥?10. CrossRef
23. Besselink MG, Van Santvoort H, Bollen TL, Van Leeuwen MS, Hofker S, Boermeester MA, / et al.: Minimally Invasive Approach in Acute Necrotising Pancreatitis: a Strategy for a Selected Subgroup or a Potential Benefit for All? Dutch Acute Pancreatitis Study Group. / Gut 2005, 128:A171鈥?72. (abstract)
24. Besselink MG, Bollen TL, Boermeester MA, Van Ramshorst B, van Leeuwen MS, Gooszen HG: [Timing and choice of intervention in necrotising pancreatitis]. / Ned Tijdschr Geneeskd 2005, 149:501鈥?06.
25. Besselink MGH, Timmerman HM, Buskens E, Nieuwenhuijs VB, Akkermans LMA, Gooszen HG: Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a blinded, placebo-controlled randomised controlled trial. Dutch Acute Pancreatitis Study Group [ISRCTN38327949]. / BMC Surgery 2004., 4:
26. van Heek NT, Kuhlmann KF, Scholten RJ, de Castro SM, Busch OR, Van Gulik TM, / et al.: Hospital volume and mortality after pancreatic resection: a systematic review and an evaluation of intervention in the Netherlands. / Ann Surg 2005, 242:781鈥?. discussion CrossRef
27. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2482/6/6/prepub - 作者单位：Marc GH Besselink (1)
Hjalmar C van Santvoort (1)
Vincent B Nieuwenhuijs (1)
Marja A Boermeester (2)
Thomas L Bollen (3)
Erik Buskens (4)
Cornelis HC Dejong (5)
Casper HJ van Eijck (6)
Harry van Goor (7)
Sijbrand S Hofker (8)
Johan S Lameris (9)
Maarten S van Leeuwen
Rutger J Ploeg (8)
Bert van Ramshorst (10)
Alexander FM Schaapherder (11)
Miguel A Cuesta (12)
Esther CJ Consten (13)
Dirk J Gouma (2)
Erwin van der Harst (14)
Eric J Hesselink (15)
Lex PJ Houdijk (16)
Tom M Karsten (17)
Cees JHM van Laarhoven (18)
Jean-Pierre EN Pierie (19)
Camiel Rosman (20)
Ernst Jan Spillenaar Bilgen (21)
Robin Timmer (22)
Ingeborg van der Tweel (23)
Ralph J de Wit (24)
Ben JM Witteman (25)
Hein G Gooszen (1)
1. Department of Surgery, University Medical Center Utrecht, The Netherlands
2. Department of Surgery, Academic Medical Center Amsterdam, The Netherlands
3. Department of Radiology, St. Antonius Hospital Nieuwegein, The Netherlands
4. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands
5. Department of Surgery, University Hospital Maastricht and NUTRIM institute, The Netherlands
6. Department of Surgery, Erasmus Medical Center Rotterdam, The Netherlands
7. Department of Surgery, Radboud University Nijmegen Medical Centre, The Netherlands
8. Department of Surgery, University Medical Center Groningen, The Netherlands
9. Department of Radiology, Academic Medical Center Amsterdam, The Netherlands
10. Department of Surgery, St. Antonius Hospital Nieuwegein, The Netherlands
11. Department of Surgery, Leiden University Medical Center, The Netherlands
12. Department of Surgery, VU Medical Center Amsterdam, The Netherlands
13. Department of Surgery, Meander Medical Center Amersfoort, The Netherlands
14. Department of Surgery, Medical Center Rijnmond Zuid Rotterdam, The Netherlands
15. Department of Surgery, Gelre Hospitals Apeldoorn, The Netherlands
16. Department of Surgery, Medical Center Alkmaar, The Netherlands
17. Department of Surgery, Reinier de Graaf Group Delft, The Netherlands
18. Department of Surgery, St. Elisabeth Hospital Tilburg, The Netherlands
19. Department of Surgery, Medical Center Leeuwarden, The Netherlands
20. Department of Surgery, Canisius Wilhelmina Hospital Nijmegen, The Netherlands
21. Department of Surgery, Rijnstate Hospital Arnhem, The Netherlands
22. Department of Gastroenterology, St. Antonius Hospital Nieuwegein, The Netherlands
23. Utrecht University, Centre for Biostatistics, The Netherlands
24. Department of Surgery, Medical Spectrum Twente, Enschede, The Netherlands
25. Department of Gastroenterology and Hepatology, Gelderse Vallei Ede, The Netherlands
文摘
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.