Robbert A Hollemans1, Olaf J Bakker2, Marja A Boermeester3, Thomas L Bollen4, Koop Bosscha5, Marco J Bruno6, Erik Buskens7, Cornelis H Dejong8, Peter van Duijvendijk9, Casper H van Eijck10, Paul Fockens11, Harry van Goor12, Wilhelmina M van Grevenstein2, Erwin van der Harst13, Joos Heisterkamp14, Eric J Hesselink9, Sijbrand Hofker15, Alexander P Houdijk16, Tom Karsten17, Philip M Kruyt18, Cornelis J van Laarhoven12, Johan S Laméris19, Maarten S van Leeuwen20, Eric R Manusama21, I Quintus Molenaar2, Vincent B Nieuwenhuijs22, Bert van Ramshorst23, Daphne Roos24, Camiel Rosman25, Alexander F Schaapherder26, George P van der Schelling27, Robin Timmer28, Robert C Verdonk28, Ralph J de Wit29, Hein G Gooszen30, Marc G Besselink3, Hjalmar C van Santvoort31. 1. Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands. 2. Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands. 3. Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam University Medical Center, Amsterdam, the Netherlands. 4. Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands. 5. Department of Surgery, Jeroen Bosch Hospital, Den Bosch, the Netherlands. 6. Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands. 7. Department of Epidemiology, University Medical Center Groningen, and Faculty of Economics and Business, University of Groningen, Groningen, the Netherlands. 8. Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands and Department of Surgery, Universitätsklinikum Aachen, Aachen, Germany. 9. Department of Surgery, Gelre Hospital, Apeldoorn, the Netherlands. 10. Deptartment of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. 11. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam University Medical Center, Amsterdam, the Netherlands. 12. Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands. 13. Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands. 14. Department of Surgery, Elisabeth-Tweesteden Hospital, Tilburg, the Netherlands. 15. Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands. 16. Department of Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands. 17. Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 18. Department of Surgery, Hospital Gelderse Vallei, Ede, the Netherlands. 19. Department of Radiology, Amsterdam Gastroenterology and Metabolism, Amsterdam University Medical Center, Amsterdam, the Netherlands. 20. Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands. 21. Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands. 22. Department of Surgery, Isala, Zwolle, the Netherlands. 23. Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands. 24. Department of Surgery, Reinier de Graaf Hospital, Delft, the Netherlands. 25. Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands. 26. Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands. 27. Department of Surgery, Amphia Hospital, Breda, the Netherlands. 28. Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands. 29. Department of Surgery, Medical Spectrum Twente, Enschede, the Netherlands. 30. Department of Operating Rooms-Evidence Based Surgery, Radboud University Medical Center, Nijmegen, the Netherlands. 31. Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: h.vansantvoort@umcutrecht.nl.
Abstract
BACKGROUND & AIMS: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. METHODS: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores. RESULTS: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups. CONCLUSIONS: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.
RCT Entities:
BACKGROUND & AIMS: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. METHODS: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores. RESULTS: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups. CONCLUSIONS: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.
Authors: M Minghetti; A Lauro; N Pagano; S Vaccari; V D'Andrea; I R Marino; M Cervellera; V Tonini Journal: Dig Dis Sci Date: 2020-01 Impact factor: 3.199
Authors: Kifayat H Ganaie; Naseer A Choh; Arshed H Parry; Feroze A Shaheen; Irfan Robbani; Tariq A Gojwari; Manjeet Singh; Omar J Shah Journal: Pol J Radiol Date: 2021-06-15
Authors: Mary E Phillips; Andrew D Hopper; John S Leeds; Keith J Roberts; Laura McGeeney; Sinead N Duggan; Rajesh Kumar Journal: BMJ Open Gastroenterol Date: 2021-06
Authors: C M Haney; K F Kowalewski; M W Schmidt; R Koschny; E A Felinska; E Kalkum; P Probst; M K Diener; B P Müller-Stich; T Hackert; F Nickel Journal: Surg Endosc Date: 2020-02-28 Impact factor: 4.584