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

被引：63

作者：

Onnekink, Anke M. ^{[1
,2
,3
]}

Boxhoorn, Lotte ^{[1
,2
,3
]}

Timmerhuis, Hester C. ^{[3
,4
]}

Bac, Simon T. ^{[2
]}

Besselink, Marc G. ^{[2
,5
]}

Boermeester, Marja A. ^{[2
,5
]}

Bollen, Thomas L. ^{[6
]}

Bosscha, Koop ^{[7
]}

Bouwense, Stefan A. W. ^{[8
]}

Bruno, Marco J. ^{[9
]}

van Brunschot, Sandra ^{[3
]}

Cappendijk, Vincent C. ^{[10
]}

Consten, Esther C. J. ^{[11
]}

Dejong, Cornelis H. ^{[8
]}

Dijkgraaf, Marcel G. W. ^{[2
,12
]}

van Eijck, Casper H. J. ^{[13
]}

Erkelens, Willemien G. ^{[14
]}

van Goor, Harry ^{[15
]}

van Grinsven, Janneke ^{[2
,5
]}

Haveman, Jan-Willem ^{[16
]}

van Hooft, Jeanin E. ^{[17
]}

Jansen, Jeroen M. ^{[18
]}

van Lienden, Krijn P. ^{[19
]}

Meijssen, Maarten A. C. ^{[20
]}

Nieuwenhuijs, Vincent B. ^{[21
]}

Poley, Jan-Werner ^{[9
]}

Quispel, Rutger ^{[22
]}

de Ridder, Rogier J. ^{[23
]}

Romkens, Tessa E. H. ^{[24
]}

van Santvoort, Hjalmar C. ^{[4
,25
]}

Scheepers, Joris J. ^{[26
]}

Schwartz, Matthijs P. ^{[11
]}

Seerden, Tom ^{[27
]}

Spanier, Marcel B. W. ^{[28
]}

Straathof, Jan Willem A. ^{[29
]}

Timmer, Robin ^{[30
]}

Venneman, Niels G. ^{[31
]}

Verdonk, Robert C. ^{[30
]}

Vleggaar, Frank P. ^{[32
]}

van Wanrooij, Roy L. ^{[2
,33
]}

Witteman, Ben J. M. ^{[34
]}

Fockens, Paul ^{[1
,2
]}

Voermans, Rogier P. ^{[1
,2
]}

机构：

[1] Locat Univ Amsterdam, Dept Gastroenterol & Hepatol, Amsterdam UMC, Amsterdam, Netherlands

[2] Amsterdam UMC, Amsterdam Gastroenterol Endocrinol Metab, Amsterdam, Netherlands

[3] St Antonius Hosp, Dept Res & Dev, Nieuwegein, Netherlands

[4] St Antonius Hosp, Dept Surg, Nieuwegein, Netherlands

[5] Locat Univ Amsterdam, Dept Surg, Amsterdam UMC, Amsterdam, Netherlands

[6] St Antonius Hosp, Dept Radiol, Nieuwegein, Netherlands

[7] Jeroen Bosch Hosp, Dept Surg, sHertogenbosch, Netherlands

[8] Maastricht Univ Med Ctr, Dept Surg, Maastricht, Netherlands

[9] Erasmus MC Univ Med Ctr, Dept Gastroenterol & Hepatol, Rotterdam, Netherlands

[10] Jeroen Bosch Hosp, Dept Radiol, sHertogenbosch, Netherlands

[11] Meander Med Ctr, Dept Gastroenterol & Hepatol, Amersfoort, Netherlands

[12] Locat Univ Amsterdam, Amsterdam UMC, Epidemiol & Data Sci, Amsterdam, Netherlands

[13] Erasmus MC Univ Med Ctr, Dept Surg, Rotterdam, Netherlands

[14] Gelre Hosp, Dept Gastroenterol & Hepatol, Apeldoorn, Netherlands

[15] Univ Med Ctr, Dept Surg, Radboudumc, Nijmegen, Netherlands

[16] Univ Med Ctr Groningen, Dept Surg, Groningen, Netherlands

[17] Leiden Univ Med Ctr, Dept Gastroenterol & Hepatol, Leiden, Netherlands

[18] Onze Lieve Vrouwe Gasthuis OLVG, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands

[19] Locat Univ Amsterdam, Dept Radiol, Amsterdam UMC, Amsterdam, Netherlands

[20] Isala Clin, Dept Gastroenterol & Hepatol, Zwolle, Netherlands

[21] Isala Clin, Dept Surg, Zwolle, Netherlands

[22] Reinier de Graaf Grp, Dept Gastroenterol & Hepatol, Delft, Netherlands

[23] Maastricht Univ Med Ctr, Dept Gastroenterol & Hepatol, Maastricht, Netherlands

[24] Jeroen Bosch Hosp, Dept Gastroenterol & Hepatol, sHertogenbosch, Netherlands

[25] Univ Med Ctr Utrecht, Dept Surg, Utrecht, Netherlands

[26] Reinier de Graaf Grp, Dept Surg, Delft, Netherlands

[27] Amphia Hosp, Dept Gastroenterol & Hepatol, Breda, Netherlands

[28] Rijnstate Hosp, Dept Gastroenterol & Hepatol, Arnhem, Netherlands

[29] Maxima Med Ctr, Dept Gastroenterol & Hepatol, Veldhoven, Netherlands

[30] St Antonius Hosp, Dept Gastroenterol & Hepatol, Nieuwegein, Netherlands

[31] Med Spectrum Twente, Dept Gastroenterol & Hepatol, Enschede, Netherlands

[32] Univ Med Ctr Utrecht, Dept Gastroenterol & Hepatol, Utrecht, Netherlands

[33] Vrije Univ Amsterdam, Dept Gastroenterol & Hepatol, Amsterdam Gastroenterol Endocrinol Metab, Amsterdam UMC, Amsterdam, Netherlands

[34] Hosp Gelderse Vallei, Dept Gastroenterol & Hepatol, Ede, Netherlands

来源：

GASTROENTEROLOGY | 2022年 / 163卷 / 03期

关键词：

Endoscopy; Surgery; Minimally Invasive Step-up Approach; Necrotizing Pancreatitis; TENSION trial; SF-36 HEALTH SURVEY; QUALITY-OF-LIFE; DIABETES-MELLITUS; FECAL ELASTASE-1; CLASSIFICATION; FISTULA; EQ-5D;

D O I：

10.1053/j.gastro.2022.05.015

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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 followup 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.

引用

页码：712 / +

页数：25

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