Besselink MG, Boermeester MA, Bollen TL, Buskens E, Dejong CH, van Eijck CH, van Goor H, Gooszen HG, Hofker HS, Laméris JS, van Leeuwen MS, Nieuwenhuijs VB, Ploeg RJ, van Ramshorst B, van Santvoort HC, Schaapherder AF, Boermeester MA, Bollen TL, Dejong CH, van Eijck CH, van Goor H, Gooszen HG, Hofker HS, Laméris JS, van Leeuwen MS, Schaapherder AF, Timmer R, Nieuwenhuijs VB, Moll FL, Moons KG, Prokop M, Samsom M, Soeters PB, vd Tweel I, Oors J, Boermeester MA, Dejong CH, van Eijck CH, van Goor H, Gooszen HG, Hofker HS, van Ramshorst B, Schaapherder AF, van Dam RM, Rutten JP, Stoot JH, Keulemans Y, Vliegen R, Roeterdink A, Zeguers V, Ahmed Ali U, Rijnhart HG, Cirkel GA, van Erpecum KJ, Vleggaar FP, van Baal M, Schrijver M, Akkermans LM, Hazebroek EJ, Wiezer MJ, Weusten BL, Biemond HD, Ploeg RJ, Buitenhuis HT, van Vliet SU, Ramcharan S, van Dullemen HM, van Ruler O, Laméris W, Gouma DJ, Busch OR, Fockens P, Haasnoot A, Veenendaal R, Witteman BJ, Pierie JP, Spoelstra P, Dol JA, Gerritsen RT, Lange JF, Wijffels NA, van Walraven LA, Coene PP, Kubben FJ, Wijsman JH, Crolla RM, de Wit AW, Rijk MC, Stassen LP, Buscher H, Heisterkamp J, van Oostvogel H, Grubben MJ, Tan AC, van der Wal JB, Morak MJ, Pek CJ, Hermans JJ, Kuipers EJ, Poley JW, Bruno M, Jansen JB, Strijk SP, Lips D, Olsman JG, van Munster IP, Kolkman JJ, Huisman AB, Tuynman HA, Wiarda BM.
Abstract
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.)
2010 Massachusetts Medical Society