TY - JOUR
T1 - Endoscopic Versus Surgical Step-Up Approach for Infected Necrotizing Pancreatitis (ExTENSION)
T2 - Long-term Follow-up of a Randomized Trial
AU - Onnekink, Anke M.
AU - Boxhoorn, Lotte
AU - Dutch Pancreatitis Study Group
AU - Timmerhuis, Hester C.
AU - Bac, Simon T.
AU - Besselink, Marc G.
AU - Boermeester, Marja A.
AU - Bollen, Thomas L.
AU - Bosscha, Koop
AU - Bouwense, Stefan A.W.
AU - Bruno, Marco J.
AU - van Brunschot, Sandra
AU - Cappendijk, Vincent C.
AU - Consten, Esther C.J.
AU - Dejong, Cornelis H.
AU - Dijkgraaf, Marcel G.W.
AU - van Eijck, Casper H.J.
AU - Erkelens, Willemien G.
AU - van Goor, Harry
AU - van Grinsven, Janneke
AU - Haveman, Jan Willem
AU - van Hooft, Jeanin E.
AU - Jansen, Jeroen M.
AU - van Lienden, Krijn P.
AU - Meijssen, Maarten A.C.
AU - Nieuwenhuijs, Vincent B.
AU - Poley, Jan Werner
AU - Quispel, Rutger
AU - de Ridder, Rogier J.
AU - Römkens, Tessa E.H.
AU - van Santvoort, Hjalmar C.
AU - Scheepers, Joris J.
AU - Schwartz, Matthijs P.
AU - Seerden, Tom
AU - Spanier, Marcel B.W.
AU - Straathof, Jan Willem A.
AU - Timmer, Robin
AU - Venneman, Niels G.
AU - Verdonk, Robert C.
AU - Vleggaar, Frank P.
AU - van Wanrooij, Roy L.
AU - Witteman, Ben J.M.
AU - Fockens, Paul
AU - Voermans, Rogier P.
N1 - Publisher Copyright: © 2022 The Authors
PY - 2022/9/1
Y1 - 2022/9/1
N2 - Background & Aims: Previous randomized trials, including the Transluminal Endoscopic Step-Up Approach Versus Minimally Invasive Surgical Step-Up Approach in Patients With Infected Pancreatic Necrosis (TENSION) trial, demonstrated that the endoscopic step-up approach might be preferred over the surgical step-up approach in patients with infected necrotizing pancreatitis based on favorable short-term outcomes. We compared long-term clinical outcomes of both step-up approaches after a period of at least 5 years. Methods: In this long-term follow-up study, we reevaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-month follow-up. The primary end point, similar to the TENSION trial, was a composite of death and major complications. Secondary end points included individual major complications, pancreaticocutaneous fistula, reinterventions, pancreatic insufficiency, and quality of life. Results: After a mean follow-up period of 7 years, the primary end point occurred in 27 patients (53%) in the endoscopy group and in 27 patients (57%) in the surgery group (risk ratio [RR], 0.93; 95% confidence interval [CI], 0.65–1.32; P = .688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs 34%; RR, 0.23; 95% CI, 0.08–0.83). After the initial 6-month follow-up, the endoscopy group needed fewer reinterventions than the surgery group (7% vs 24%; RR, 0.29; 95% CI, 0.09–0.99). Pancreatic insufficiency and quality of life did not differ between groups. Conclusions: At long-term follow-up, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing death or major complications in patients with infected necrotizing pancreatitis. However, patients assigned to the endoscopic approach developed overall fewer pancreaticocutaneous fistulas and needed fewer reinterventions after the initial 6-month follow-up. Netherlands Trial Register no: NL8571.
AB - Background & Aims: Previous randomized trials, including the Transluminal Endoscopic Step-Up Approach Versus Minimally Invasive Surgical Step-Up Approach in Patients With Infected Pancreatic Necrosis (TENSION) trial, demonstrated that the endoscopic step-up approach might be preferred over the surgical step-up approach in patients with infected necrotizing pancreatitis based on favorable short-term outcomes. We compared long-term clinical outcomes of both step-up approaches after a period of at least 5 years. Methods: In this long-term follow-up study, we reevaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-month follow-up. The primary end point, similar to the TENSION trial, was a composite of death and major complications. Secondary end points included individual major complications, pancreaticocutaneous fistula, reinterventions, pancreatic insufficiency, and quality of life. Results: After a mean follow-up period of 7 years, the primary end point occurred in 27 patients (53%) in the endoscopy group and in 27 patients (57%) in the surgery group (risk ratio [RR], 0.93; 95% confidence interval [CI], 0.65–1.32; P = .688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs 34%; RR, 0.23; 95% CI, 0.08–0.83). After the initial 6-month follow-up, the endoscopy group needed fewer reinterventions than the surgery group (7% vs 24%; RR, 0.29; 95% CI, 0.09–0.99). Pancreatic insufficiency and quality of life did not differ between groups. Conclusions: At long-term follow-up, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing death or major complications in patients with infected necrotizing pancreatitis. However, patients assigned to the endoscopic approach developed overall fewer pancreaticocutaneous fistulas and needed fewer reinterventions after the initial 6-month follow-up. Netherlands Trial Register no: NL8571.
UR - http://www.scopus.com/inward/record.url?scp=85134805117&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2022.05.015
DO - 10.1053/j.gastro.2022.05.015
M3 - Article
C2 - 35580661
AN - SCOPUS:85134805117
VL - 163
SP - 712-722.e14
JO - Gastroenterology
JF - Gastroenterology
SN - 0016-5085
IS - 3
ER -