Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial
Dutch Pancreatitis Study Group
(2022) Gastroenterology, volume 163, issue 3, pp. 712 - 722.e14
(Article)
Abstract
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
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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.
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Keywords: Endoscopy, Minimally Invasive Step-up Approach, Necrotizing Pancreatitis, Surgery, TENSION trial, Gastroenterology, Hepatology, Journal Article
ISSN: 0016-5085
Publisher: W.B. Saunders Ltd
Note: Funding Information: The study design was preregistered at the Netherlands Trial Register (https://www.trialregister.nl/trial/8571) before the study was conducted. Requests for data can be made to the corresponding author and will be discussed during a meeting of the Dutch Pancreatitis Study Group. Individual deidentified participant data used in this study will only be shared after approval by the Dutch Pancreatitis Study Group. Anke M. Onnekink, MD (Conceptualization: Equal; Formal analysis: Lead; Investigation: Lead; Methodology: Equal; Project administration: Lead; Visualization: Lead; Writing – original draft: Lead). Lotte Boxhoorn, MD, PhD (Conceptualization: Supporting; Methodology: Equal; Project administration: Supporting; Supervision: Supporting; Validation: Supporting; Writing – review & editing: Lead). Hester C. Timmerhuis, MD (Investigation: Supporting; Resources: Equal; Writing – review & editing: Supporting). Simon T. Bac, MD (Conceptualization: Supporting). Marc G. Besselink, MD, PhD (Conceptualization: Supporting; Resources: Supporting; Writing – review & editing: Equal). Marja A. Boermeester, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Thomas L. Bollen, MD, PhD (Resources: Supporting). Koop Bosscha, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Marco J. Bruno, MD, PhD (Resources: Supporting; Writing – review & editing: Equal). Sandra van Brunschot, MD, PhD (Resources: Equal; Writing – review & editing: Supporting). Stefan A.W. Bouwense, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Vincent C. Cappendijk, MD (Resources: Supporting; Writing – review & editing: Supporting). Esther C.J. Consten, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Marcel G.W. Dijkgraaf, PhD (Validation: Supporting; Writing – review & editing: Supporting). Cornelis H. Dejong, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Casper H.J. van Eijck, MD, PhD (Resources: Supporting; Writing – review & editing: Equal). Willemien G. Erkelens, MD, PhD (Resources: Supporting). Harry van Goor, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Janneke van Grinsven, MD, PhD (Resources: Supporting). Jan-Willem Haveman, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Jeanin E. van Hooft, MD, PhD (Resources: Supporting; Writing – review & editing: Equal). Jeroen M. Jansen, MD (Resources: Supporting; Writing – review & editing: Supporting). Krijn P. van Lienden, MD (Resources: Supporting; Writing – review & editing: Supporting). Maarten A.C. Meijssen, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Vincent B. Nieuwenhuijs, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Jan-Werner Poley, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Rutger Quispel, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Rogier J. de Ridder, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Tessa E.H. Römkens, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Hjalmar C. van Santvoort, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Joris J. Scheepers, MD (Resources: Supporting). Matthijs P. Schwartz, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Tom Seerden, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Marcel B.W. Spanier, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Jan Willem A. Straathof, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Robin Timmer, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Niels G. Venneman, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Robert C. Verdonk, MD, PhD (Resources: Supporting; Writing – review & editing: Equal). Frank P. Vleggaar, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Roy L. van Wanrooij, M.D. (Writing – review & editing: Supporting). Ben J.M. Witteman, MD, PhD (Resources: Supporting; Writing – review & editing: Supporting). Paul Fockens, MD, PhD (Conceptualization: Supporting; Methodology: Supporting; Supervision: Supporting; Writing – review & editing: Supporting). Rogier P. Voermans, MD, PhD (Conceptualization: Lead; Funding acquisition: Lead; Methodology: Lead; Project administration: Lead; Supervision: Lead; Writing – review & editing: Supporting). Conflicts of interest The authors disclose the following: Marc G. Besselink reports grants from Ethicon Endo-Surgery, Intuitive Surgical, and Medtronic. Marco J. Bruno reports consulting for Boston Scientific, Cook Medical, and Pentax Medical, and financial support from Boston Scientific, Cook Medical, and Pentax Medical. Paul Fockens reports personal fees from Cook Medical, Ethicon Endo-Surgery, and Olympus Medical. Jan-Werner Poley reports personal and other fees from Cook Endoscopy, Boston Scientific, and Pentax Medical. Rogier P. Voermans reports grants and personal fees from Boston Scientific. All financial relationships were outside the submitted work. The other authors disclosed no conflicts. Funding Information: Conflicts of interest The authors disclose the following: Marc G. Besselink reports grants from Ethicon Endo-Surgery, Intuitive Surgical, and Medtronic. Marco J. Bruno reports consulting for Boston Scientific, Cook Medical, and Pentax Medical, and financial support from Boston Scientific, Cook Medical, and Pentax Medical. Paul Fockens reports personal fees from Cook Medical, Ethicon Endo-Surgery, and Olympus Medical. Jan-Werner Poley reports personal and other fees from Cook Endoscopy, Boston Scientific, and Pentax Medical. Rogier P. Voermans reports grants and personal fees from Boston Scientific. All financial relationships were outside the submitted work. The other authors disclosed no conflicts. Publisher Copyright: © 2022 The Authors
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