TY - JOUR
T1 - Endoscopic or surgical step-up approach for infected necrotising pancreatitis
T2 - a multicentre randomised trial
AU - van Brunschot, Sandra
AU - van Grinsven, Janneke
AU - van Santvoort, Hjalmar C.
AU - Bakker, Olaf J.
AU - Besselink, Marc G.
AU - Boermeester, Marja A.
AU - Bollen, Thomas L.
AU - Bosscha, Koop
AU - Bouwense, Stefan A.
AU - Bruno, Marco J.
AU - Cappendijk, Vincent C.
AU - Consten, Esther C.
AU - Dejong, Cornelis H.
AU - van Eijck, Casper H.
AU - Erkelens, Willemien G.
AU - van Goor, Harry
AU - van Grevenstein, Wilhelmina M. U.
AU - Haveman, Jan-Willem
AU - Hofker, Sijbrand H.
AU - Jansen, Jeroen M.
AU - Lameris, Johan S.
AU - van Lienden, Krijn P.
AU - Meijssen, Maarten A.
AU - Mulder, Chris J.
AU - Nieuwenhuijs, Vincent B.
AU - Poley, Jan-Werner
AU - Quispel, Rutger
AU - de Ridder, Rogier J.
AU - Romkens, Tessa E.
AU - Scheepers, Joris J.
AU - Schepers, Nicolien J.
AU - Schwartz, Matthijs P.
AU - Seerden, Tom
AU - Spanier, B. W. Marcel
AU - Straathof, Jan Willem A.
AU - Strijker, Marin
AU - Timmer, Robin
AU - Venneman, Niels G.
AU - Vleggaar, Frank P.
AU - Voermans, Rogier P.
AU - Witteman, Ben J.
AU - Gooszen, Hein G.
AU - Dijkgraaf, Marcel G.
AU - Fockens, Paul
AU - Dutch Pancreatitis Study Grp
PY - 2018/1/6
Y1 - 2018/1/6
N2 - Background Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. Methods In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. Findings Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0.97, 95% CI 0.62-1.51; p= 0.88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1.38, 95% CI 0.53-3.59, p= 0.50), nor did any of the major complications included in the primary endpoint. Interpretation In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference.
AB - Background Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. Methods In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. Findings Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0.97, 95% CI 0.62-1.51; p= 0.88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1.38, 95% CI 0.53-3.59, p= 0.50), nor did any of the major complications included in the primary endpoint. Interpretation In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference.
KW - TRANSGASTRIC NECROSECTOMY
KW - CATHETER DRAINAGE
KW - NECROSIS
KW - MANAGEMENT
KW - GUIDELINES
KW - THERAPY
KW - SUCCESS
KW - VIDEOS
KW - METAL
U2 - 10.1016/S0140-6736(17)32404-2
DO - 10.1016/S0140-6736(17)32404-2
M3 - Article
SN - 0140-6736
VL - 391
SP - 51
EP - 58
JO - Lancet
JF - Lancet
IS - 10115
ER -