Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial

Anke M Onnekink; Lotte Boxhoorn; 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 Grinsven; Jan-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 Vennema; Robert C Verdonk; Frank P Vleggaar; Roy L van Wanrooij; Ben J M Witteman; Paul Fockens; Rogier P Voermans; Dutch Pancreatitis Study Group

doi:10.1053/j.gastro.2022.05.015

Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial

Anke M Onnekink, Lotte Boxhoorn, 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 Grinsven, Jan-Willem HavemanJeanin 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 Vennema, Robert C Verdonk, Frank P Vleggaar, Roy L van Wanrooij, Ben J M Witteman, Paul Fockens, Rogier P Voermans^*, Dutch Pancreatitis Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND & AIMS: Previous randomized trials, including the 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 re-evaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-months follow-up. The primary endpoint, similar to the TENSION trial, was a composite of death and major complications. Secondary endpoints included individual major complications, pancreaticocutaneous fistula, re-interventions, pancreatic insufficiency, and quality of life.

RESULTS: After a mean follow-up period of 7 years, the primary endpoint occurred in 27 patients (53%) in the endoscopy and in 27 patients (57%) in the surgery group (risk ratio [RR] 0.93, 95% confidence interval [CI] 0.65 to 1.32, P=0.688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs. 34%; RR 0.23, 95% CI 0.08 to 0.83). After the initial 6-months follow-up, the endoscopy group needed fewer re-interventions than the surgery group (7% vs. 24%; RR 0.29, 95% CI 0.09 to 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 re-interventions after the initial 6-months follow-up. Netherlands Trial Register no: NL8571.

Original language	English
Pages (from-to)	712-722.e14
Number of pages	25
Journal	Gastroenterology
Volume	163
Issue number	3
Early online date	14 May 2022
DOIs	https://doi.org/10.1053/j.gastro.2022.05.015
Publication status	Published - Sept 2022

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Onnekink, A. M., Boxhoorn, L., Timmerhuis, H. C., Bac, S. T., Besselink, M. G., Boermeester, M. A., Bollen, T. L., Bosscha, K., Bouwense, S. A. W., Bruno, M. J., van Brunschot, S., Cappendijk, V. C., Consten, E. C. J., Dejong, C. H., Dijkgraaf, M. G. W., van Eijck, C. H. J., Erkelens, W. G., van Goor, H., van Grinsven, J., ... Dutch Pancreatitis Study Group (2022). Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial. Gastroenterology, 163(3), 712-722.e14. https://doi.org/10.1053/j.gastro.2022.05.015

@article{30cb92ffaf584d85a265332dcaea4439,

title = "Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial",

abstract = "BACKGROUND & AIMS: Previous randomized trials, including the 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 re-evaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-months follow-up. The primary endpoint, similar to the TENSION trial, was a composite of death and major complications. Secondary endpoints included individual major complications, pancreaticocutaneous fistula, re-interventions, pancreatic insufficiency, and quality of life.RESULTS: After a mean follow-up period of 7 years, the primary endpoint occurred in 27 patients (53%) in the endoscopy and in 27 patients (57%) in the surgery group (risk ratio [RR] 0.93, 95% confidence interval [CI] 0.65 to 1.32, P=0.688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs. 34%; RR 0.23, 95% CI 0.08 to 0.83). After the initial 6-months follow-up, the endoscopy group needed fewer re-interventions than the surgery group (7% vs. 24%; RR 0.29, 95% CI 0.09 to 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 re-interventions after the initial 6-months follow-up. Netherlands Trial Register no: NL8571.",

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

year = "2022",

month = sep,

doi = "10.1053/j.gastro.2022.05.015",

language = "English",

volume = "163",

pages = "712--722.e14",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "Elsevier Saunders",

number = "3",

}

Onnekink, AM, Boxhoorn, L, Timmerhuis, HC, Bac, ST, Besselink, MG, Boermeester, MA, Bollen, TL, Bosscha, K, Bouwense, SAW, Bruno, MJ, van Brunschot, S, Cappendijk, VC, Consten, ECJ, Dejong, CH, Dijkgraaf, MGW, van Eijck, CHJ, Erkelens, WG, van Goor, H, van Grinsven, J, Haveman, J-W, van Hooft, JE, Jansen, JM, van Lienden, KP, Meijssen, MAC, Nieuwenhuijs, VB, Poley, J-W, Quispel, R, de Ridder, RJ, Römkens, TEH, van Santvoort, HC, Scheepers, JJ, Schwartz, MP, Seerden, T, Spanier, MBW, Straathof, JWA, Timmer, R, Vennema, NG, Verdonk, RC, Vleggaar, FP, van Wanrooij, RL, Witteman, BJM, Fockens, P, Voermans, RP & Dutch Pancreatitis Study Group 2022, 'Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial', Gastroenterology, vol. 163, no. 3, pp. 712-722.e14. https://doi.org/10.1053/j.gastro.2022.05.015

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 - 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 - Vennema, 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

AU - Dutch Pancreatitis Study Group

PY - 2022/9

Y1 - 2022/9

N2 - BACKGROUND & AIMS: Previous randomized trials, including the 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 re-evaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-months follow-up. The primary endpoint, similar to the TENSION trial, was a composite of death and major complications. Secondary endpoints included individual major complications, pancreaticocutaneous fistula, re-interventions, pancreatic insufficiency, and quality of life.RESULTS: After a mean follow-up period of 7 years, the primary endpoint occurred in 27 patients (53%) in the endoscopy and in 27 patients (57%) in the surgery group (risk ratio [RR] 0.93, 95% confidence interval [CI] 0.65 to 1.32, P=0.688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs. 34%; RR 0.23, 95% CI 0.08 to 0.83). After the initial 6-months follow-up, the endoscopy group needed fewer re-interventions than the surgery group (7% vs. 24%; RR 0.29, 95% CI 0.09 to 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 re-interventions after the initial 6-months follow-up. Netherlands Trial Register no: NL8571.

AB - BACKGROUND & AIMS: Previous randomized trials, including the 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 re-evaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-months follow-up. The primary endpoint, similar to the TENSION trial, was a composite of death and major complications. Secondary endpoints included individual major complications, pancreaticocutaneous fistula, re-interventions, pancreatic insufficiency, and quality of life.RESULTS: After a mean follow-up period of 7 years, the primary endpoint occurred in 27 patients (53%) in the endoscopy and in 27 patients (57%) in the surgery group (risk ratio [RR] 0.93, 95% confidence interval [CI] 0.65 to 1.32, P=0.688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs. 34%; RR 0.23, 95% CI 0.08 to 0.83). After the initial 6-months follow-up, the endoscopy group needed fewer re-interventions than the surgery group (7% vs. 24%; RR 0.29, 95% CI 0.09 to 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 re-interventions after the initial 6-months follow-up. Netherlands Trial Register no: NL8571.

U2 - 10.1053/j.gastro.2022.05.015

DO - 10.1053/j.gastro.2022.05.015

M3 - Article

C2 - 35580661

SN - 0016-5085

VL - 163

SP - 712-722.e14

JO - Gastroenterology

JF - Gastroenterology

IS - 3

ER -

Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial

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