TY - JOUR
T1 - Surgical Complications in Patients with (borderline) Resectable Pancreatic Cancer after Neoadjuvant Therapy in the PREOPANC-2 Randomized Controlled Trial
AU - Dekker, Esther N
AU - Theijse, Rutger T
AU - van Dam, Jacob L
AU - Janssen, Quisette P
AU - Stoop, Thomas F
AU - Bonsing, Bert A
AU - Bosscha, Koop P
AU - Bouwense, Stefan A W
AU - Busch, Olivier R
AU - Coene, Peter-Paul L O
AU - van Eijck, Casper H J
AU - van Her Harst, Erwin
AU - de Hingh, Ignace H J T
AU - Karsten, Tom M
AU - Kazemier, Geert
AU - van der Kolk, Marion B
AU - Liem, Mike S L
AU - Mieog, J Sven D
AU - Nieuwenhuijs, Vincent B
AU - Patijn, Gijs A
AU - van Santvoort, Hjalmar C
AU - Schreinemakers, Jennifer M J
AU - de Wilde, Roeland F
AU - Wit, Fennie
AU - Zonderhuis, Babs M
AU - Homs, Marjolein Y V
AU - van Tienhoven, Geertjan
AU - Wilmink, Johanna W
AU - Besselink, Marc G
AU - Koerkamp, Bas Groot
AU - Dutch Pancreatic Cancer Group
AU - de Vos-Geelen, J.M.P.G.M.
AU - Willems, Ruth
PY - 2025/8/12
Y1 - 2025/8/12
N2 - OBJECTIVE: To compare the incidence of major surgical complications between patients with (borderline) resectable pancreatic cancer treated with neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy. SUMMARY OF BACKGROUND DATA: There are ongoing concerns regarding the possible adverse impact of neoadjuvant treatment on postoperative complication rates following pancreatectomy. METHODS: This study was a predefined analysis within the investigator-initiated nationwide randomized controlled PREOPANC-2 trial. Patients with (borderline) resectable pancreatic cancer were randomized to receive neoadjuvant FOLFIRINOX (FFX group) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT group), both followed by surgery, and adjuvant gemcitabine only in the CRT group. Surgical complications including postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, postoperative interventions, and 90-day mortality were compared, with major complications defined as Clavien-Dindo grade =3. RESULTS: Between June 5, 2018, and January 28, 2021, in total 375 patients were randomized, of whom 280 (74.7%) underwent pancreatic resection. A pancreatoduodenectomy was performed in 238 patients (85.0%), left pancreatectomy in 41 patients (14.6%), and total pancreatectomy in one patient (0.4%). The incidence of major surgical complications was similar between the FFX and CRT groups (26.8% versus 27.5%, P=0.884). No differences were observed in the risk of postoperative pancreatic fistula grade B/C (9.9% versus 4.4%, P=0.076), postpancreatectomy hemorrhage grade B/C (7.7% versus 3.6%, P=0.137), bile leakage grade B/C (2.5% versus 2.5%, P>0.999), and postoperative interventions (26.1% versus 26.8%, P=0.886). Surgical reoperation was performed in nine patients (6.3%) in the FFX group and eight patients (5.8%) in the CRT group (P=0.850). The postoperative 90-day mortality was 1.4% in the FFX group (2/142 patients) and 2.9% in the CRT group (4/138 patients) (P=0.442). CONCLUSIONS: In the PREOPANC-2 randomized trial, the risk of major surgical complications after pancreatic resection following neoadjuvant FOLFIRINOX or neoadjuvant gemcitabine-based chemoradiotherapy was similar with an overall low 90-day mortality.
AB - OBJECTIVE: To compare the incidence of major surgical complications between patients with (borderline) resectable pancreatic cancer treated with neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy. SUMMARY OF BACKGROUND DATA: There are ongoing concerns regarding the possible adverse impact of neoadjuvant treatment on postoperative complication rates following pancreatectomy. METHODS: This study was a predefined analysis within the investigator-initiated nationwide randomized controlled PREOPANC-2 trial. Patients with (borderline) resectable pancreatic cancer were randomized to receive neoadjuvant FOLFIRINOX (FFX group) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT group), both followed by surgery, and adjuvant gemcitabine only in the CRT group. Surgical complications including postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, postoperative interventions, and 90-day mortality were compared, with major complications defined as Clavien-Dindo grade =3. RESULTS: Between June 5, 2018, and January 28, 2021, in total 375 patients were randomized, of whom 280 (74.7%) underwent pancreatic resection. A pancreatoduodenectomy was performed in 238 patients (85.0%), left pancreatectomy in 41 patients (14.6%), and total pancreatectomy in one patient (0.4%). The incidence of major surgical complications was similar between the FFX and CRT groups (26.8% versus 27.5%, P=0.884). No differences were observed in the risk of postoperative pancreatic fistula grade B/C (9.9% versus 4.4%, P=0.076), postpancreatectomy hemorrhage grade B/C (7.7% versus 3.6%, P=0.137), bile leakage grade B/C (2.5% versus 2.5%, P>0.999), and postoperative interventions (26.1% versus 26.8%, P=0.886). Surgical reoperation was performed in nine patients (6.3%) in the FFX group and eight patients (5.8%) in the CRT group (P=0.850). The postoperative 90-day mortality was 1.4% in the FFX group (2/142 patients) and 2.9% in the CRT group (4/138 patients) (P=0.442). CONCLUSIONS: In the PREOPANC-2 randomized trial, the risk of major surgical complications after pancreatic resection following neoadjuvant FOLFIRINOX or neoadjuvant gemcitabine-based chemoradiotherapy was similar with an overall low 90-day mortality.
KW - PDAC
KW - PREOPANC-2
KW - RCT
KW - investigator-initiated
KW - nationwide
KW - surgical complications
U2 - 10.1097/SLA.0000000000006910
DO - 10.1097/SLA.0000000000006910
M3 - Article
SN - 0003-4932
JO - Annals of Surgery
JF - Annals of Surgery
ER -