Endoscopic Versus Surgical Step-Up Approach for Infected Necrotizing Pancreatitis (ExTENSION): Long-term Follow-up of a Randomized Trial

Anke M. Onnekink, Lotte Boxhoorn, Dutch Pancreatitis Study Group, Hester C. Timmerhuis, Simon T. Bac, Marc G. Besselink, Marja A. Boermeester, Thomas L. Bollen, Koop Bosscha, Stefan A.W. Bouwense, Marco J. Bruno, Sandra van Brunschot, Vincent C. Cappendijk, Esther C.J. Consten, Cornelis H. Dejong, Marcel G.W. Dijkgraaf, Casper H.J. van Eijck, Willemien G. Erkelens, Harry van Goor, Janneke van GrinsvenJan Willem Haveman, Jeanin E. van Hooft, Jeroen M. Jansen, Krijn P. van Lienden, Maarten A.C. Meijssen, Vincent B. Nieuwenhuijs, Jan Werner Poley, Rutger Quispel, Rogier J. de Ridder, Tessa E.H. Römkens, Hjalmar C. van Santvoort, Joris J. Scheepers, Matthijs P. Schwartz, Tom Seerden, Marcel B.W. Spanier, Jan Willem A. Straathof, Robin Timmer, Niels G. Venneman, Robert C. Verdonk, Frank P. Vleggaar, Roy L. van Wanrooij, Ben J.M. Witteman, Paul Fockens, Rogier P. Voermans*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)712-722.e14
JournalGastroenterology
Volume163
Issue number3
DOIs
Publication statusPublished - 1 Sep 2022

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