A step-up approach or open necrosectomy for necrotizing pancreatitis.
BACKGROUND
Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach.


METHODS
In this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death.


RESULTS
The primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P=0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P=0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P=0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P=0.03) and new-onset diabetes (16% vs. 38%, P=0.02).


CONCLUSIONS
A minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)
van Santvoort
Hjalmar C
HC
University Medical Center, Utrecht, The Netherlands.
Besselink
Marc G
MG
Bakker
Olaf J
OJ
Hofker
H Sijbrand
HS
Boermeester
Marja A
MA
Dejong
Cornelis H
CH
van Goor
Harry
H
Schaapherder
Alexander F
AF
van Eijck
Casper H
CH
Bollen
Thomas L
TL
van Ramshorst
Bert
B
Nieuwenhuijs
Vincent B
VB
Timmer
Robin
R
Laméris
Johan S
JS
Kruyt
Philip M
PM
Manusama
Eric R
ER
van der Harst
Erwin
E
van der Schelling
George P
GP
Karsten
Tom
T
Hesselink
Eric J
EJ
van Laarhoven
Cornelis J
CJ
Rosman
Camiel
C
Bosscha
Koop
K
de Wit
Ralph J
RJ
Houdijk
Alexander P
AP
van Leeuwen
Maarten S
MS
Buskens
Erik
E
Gooszen
Hein G
HG
D003646:Debridement; D004322:Drainage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D009102:Multiple Organ Failure / Q000517:prevention & control; D010179:Pancreas / Q000601:surgery*; D019283:Pancreatitis, Acute Necrotizing / Q000401:mortality / Q000601:surgery*; D011183:Postoperative Complications / Q000517:prevention & control; D011786:Quality Control; D020535:Video-Assisted Surgery