Prophylactic antibiotics for pancreaticoduodenectomy: study protocol for a multicenter randomized controlled trial comparing tazobactam/piperacillin versus ampicillin/sulbactam.
- 1Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-Cho, Chuo-ku, Kobe, 650-0017, Japan.
- 2Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-Cho, Chuo-ku, Kobe, 650-0017, Japan. [email protected].
Abstract
Background
Pancreaticoduodenectomy (PD) is associated with a high incidence of surgical site infection (SSI), reported in 20-40% of cases. In patients undergoing preoperative biliary drainage (PBD), the risk is further increased due to biliary contamination. Tazobactam/piperacillin (TAZ/PIPC) has been shown to reduce SSI compared with cephalosporins; however, no prospective trial has directly compared TAZ/PIPC with ampicillin/sulbactam (ABPC/SBT), which is widely used in pancreatic surgery. This study aims to evaluate the superiority of TAZ/PIPC over ABPC/SBT in preventing SSI after PD.Methods
This is a multicenter, open-label, randomized controlled trial. A total of 320 patients undergoing PD will be randomized (1:1) to receive either TAZ/PIPC or ABPC/SBT as perioperative prophylactic antibiotics. Randomization will be stratified by PBD, minimally invasive surgery (MIS), and pancreatic ductal adenocarcinoma (PDAC). Antibiotics will be administered within 60 min before incision, redosed intraoperatively every 2-4 h, and continued every 8 h until postoperative day 1. The primary endpoint is the incidence of SSI within 30 days postoperatively, defined according to CDC criteria. Secondary endpoints include postoperative complications (Clavien-Dindo ≥IIIa), clinically relevant postoperative pancreatic fistula (ISGPS grade B/C), delayed gastric emptying, postpancreatectomy hemorrhage, bile leakage, mortality, reoperation, readmission, C. difficile colitis, and detection of antimicrobial-resistant organisms.Discussion
This trial will provide the first direct comparison between TAZ/PIPC and ABPC/SBT in PD. The results are expected to contribute to optimizing perioperative antibiotic strategies while balancing SSI prevention and antimicrobial resistance.Trial registration
Japan Registry of Clinical Trials (jRCT), jRCTs051260063.
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BibTeX
@article{mizumoto2026prophylactic,
title = {{Prophylactic antibiotics for pancreaticoduodenectomy: study protocol for a multicenter randomized controlled trial comparing tazobactam/piperacillin versus ampicillin/sulbactam.}},
author = {Takuya Mizumoto and Yoshihide Nanno and Jun Ishida and Yuki Ueda and Dongha Lee and Masayuki Akita and Riki Asakura and Hiroyuki Nakamura and Taisuke Okawa and Masaharu Yokota and Koki Hamano and Shohei Komatsu},
journal = {BMC surgery},
year = {2026},
month = aug,
doi = {10.1186/s12893-026-04092-8},
url = {https://europepmc.org/article/MED/42958223},
note = {CC BY},
}
RIS
TY - JOUR
TI - Prophylactic antibiotics for pancreaticoduodenectomy: study protocol for a multicenter randomized controlled trial comparing tazobactam/piperacillin versus ampicillin/sulbactam.
AU - Takuya Mizumoto
AU - Yoshihide Nanno
AU - Jun Ishida
AU - Yuki Ueda
AU - Dongha Lee
AU - Masayuki Akita
AU - Riki Asakura
AU - Hiroyuki Nakamura
AU - Taisuke Okawa
AU - Masaharu Yokota
AU - Koki Hamano
AU - Shohei Komatsu
PY - 2026
DA - 2026/08/01
JO - BMC surgery
DO - 10.1186/s12893-026-04092-8
UR - https://europepmc.org/article/MED/42958223
AB - Background Pancreaticoduodenectomy (PD) is associated with a high incidence of surgical site infection (SSI), reported in 20-40% of cases. In patients undergoing preoperative biliary drainage (PBD), the risk is further increased due to biliary contamination. Tazobactam/piperacillin (TAZ/PIPC) has been shown to reduce SSI compared with cephalosporins; however, no prospective trial has directly compared TAZ/PIPC with ampicillin/sulbactam (ABPC/SBT), which is widely used in pancreatic surgery. This study aims to evaluate the superiority of TAZ/PIPC over ABPC/SBT in preventing SSI after PD.Methods This is a multicenter, open-label, randomized controlled trial. A total of 320 patients undergoing PD will be randomized (1:1) to receive either TAZ/PIPC or ABPC/SBT as perioperative prophylactic antibiotics. Randomization will be stratified by PBD, minimally invasive surgery (MIS), and pancreatic ductal adenocarcinoma (PDAC). Antibiotics will be administered within 60 min before incision, redosed intraoperatively every 2-4 h, and continued every 8 h until postoperative day 1. The primary endpoint is the incidence of SSI within 30 days postoperatively, defined according to CDC criteria. Secondary endpoints include postoperative complications (Clavien-Dindo ≥IIIa), clinically relevant postoperative pancreatic fistula (ISGPS grade B/C), delayed gastric emptying, postpancreatectomy hemorrhage, bile leakage, mortality, reoperation, readmission, C. difficile colitis, and detection of antimicrobial-resistant organisms.Discussion This trial will provide the first direct comparison between TAZ/PIPC and ABPC/SBT in PD. The results are expected to contribute to optimizing perioperative antibiotic strategies while balancing SSI prevention and antimicrobial resistance.Trial registration Japan Registry of Clinical Trials (jRCT), jRCTs051260063.
SN - 1471-2482
ER -