Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]
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- 作者：Sandra van Brunschot (1) (2)
Janneke van Grinsven (1) (2)
Rogier P Voermans (1)
Olaf J Bakker (3)
Marc GH Besselink (4)
Marja A Boermeester (4)
Thomas L Bollen (5)
Koop Bosscha (6)
Stefan A Bouwense (2) (7)
Marco J Bruno (8)
Vincent C Cappendijk (9)
Esther C Consten (10)
Cornelis H Dejong (11)
Marcel GW Dijkgraaf (12)
Casper H van Eijck (13)
G Willemien Erkelens (14)
Harry van Goor (7)
Mohammed Hadithi (15)
Jan-Willem Haveman (16)
Sijbrand H Hofker (16)
Jeroen JM Jansen (17)
Johan S Laméris (18)
Krijn P van Lienden (18)
Eric R Manusama (19)
Maarten A Meijssen (20)
Chris J Mulder (21)
Vincent B Nieuwenhuis (22)
Jan-Werner Poley (8)
Rogier J de Ridder (23)
Camiel Rosman (24)
Alexander F Schaapherder (25)
Joris J Scheepers (26)
Erik J Schoon (27)
Tom Seerden (28)
BW Marcel Spanier (29)
Jan Willem A Straathof (30)
Robin Timmer (31)
Niels G Venneman (32)
Frank P Vleggaar (33)
Ben J Witteman (34)
Hein G Gooszen (2)
Hjalmar C van Santvoort (3)
Paul Fockens (1) - 关键词：Acute pancreatitis ; Necrotising ; Treatment ; Drainage ; Trial ; Endoscopy ; Minimally invasive ; Surgery ; Necrosectomy ; Pancreas
- 刊名：BMC Gastroenterology
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：13
- 期：1
- 全文大小：1,058 KB
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31. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-230X/13/161/prepub - 作者单位：Sandra van Brunschot (1) (2)
Janneke van Grinsven (1) (2)
Rogier P Voermans (1)
Olaf J Bakker (3)
Marc GH Besselink (4)
Marja A Boermeester (4)
Thomas L Bollen (5)
Koop Bosscha (6)
Stefan A Bouwense (2) (7)
Marco J Bruno (8)
Vincent C Cappendijk (9)
Esther C Consten (10)
Cornelis H Dejong (11)
Marcel GW Dijkgraaf (12)
Casper H van Eijck (13)
G Willemien Erkelens (14)
Harry van Goor (7)
Mohammed Hadithi (15)
Jan-Willem Haveman (16)
Sijbrand H Hofker (16)
Jeroen JM Jansen (17)
Johan S Laméris (18)
Krijn P van Lienden (18)
Eric R Manusama (19)
Maarten A Meijssen (20)
Chris J Mulder (21)
Vincent B Nieuwenhuis (22)
Jan-Werner Poley (8)
Rogier J de Ridder (23)
Camiel Rosman (24)
Alexander F Schaapherder (25)
Joris J Scheepers (26)
Erik J Schoon (27)
Tom Seerden (28)
BW Marcel Spanier (29)
Jan Willem A Straathof (30)
Robin Timmer (31)
Niels G Venneman (32)
Frank P Vleggaar (33)
Ben J Witteman (34)
Hein G Gooszen (2)
Hjalmar C van Santvoort (3)
Paul Fockens (1)
1. Department of Gastroenterology and Hepatology, University of Amsterdam, Amsterdam, The Netherlands
2. Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
3. Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
4. Department of Surgery, University of Amsterdam, Amsterdam, The Netherlands
5. Department of Radiology, St Antonius Hospital, Nieuwegein, The Netherlands
6. Department of Surgery, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands
7. Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
8. Department of Gastroenterology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
9. Department of Radiology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands
10. Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands
11. Department of Surgery and NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands
12. Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
13. Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
14. Department of Gastroenterology, Gelre Hospital, Apeldoorn, The Netherlands
15. Department of Gastroenterology, Maasstad Hospital, Rotterdam, The Netherlands
16. Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands
17. Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
18. Department of Radiology, University of Amsterdam, Amsterdam, The Netherlands
19. Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands
20. Department of Gastroenterology, Isala Clinics, Zwolle, The Netherlands
21. Department of Gastroenterology, VU Medical Center, Amsterdam, The Netherlands
22. Department of Surgery, Isala Clinics, Zwolle, The Netherlands
23. Department of Gastroenterology, Maastricht University Medical Center, Maastricht, The Netherlands
24. Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands
25. Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands
26. Department of Surgery, Reinier de Graaf Group, Delft, The Netherlands
27. Department of Gastroenterology, Catharina Hospital, Eindhoven, The Netherlands
28. Department of Gastroenterology, Amphia Hospital, Breda, The Netherlands
29. Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands
30. Department of Gastroenterology, Máxima Medical Center, Veldhoven, The Netherlands
31. Department of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands
32. Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands
33. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
34. Department of Gastroenterology, Hospital Gelderse Vallei, Ede, The Netherlands - ISSN：1471-230X
文摘
Background Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes. Methods/Design The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4?year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6?months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs. Discussion The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.