Patients indicated for pancreatoduodenectomy pancreatoduodenectomy
Conditions
Interventions
Intervention group: Perioperative prophylactic administration of piperacillin/tazobactam (TAZ/PIPC)
Control group: Perioperative prophylactic administration of ampicillin/sulbactam (ABPC/SBT)
Sponsors
Nanno Yoshihide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 years or older at the time of obtaining informed consent. (2) Patients scheduled to undergo pancreaticoduodenectomy. (3) Patients who have provided written informed consent for participation in the study of their own free will.
Exclusion criteria
Exclusion criteria: (1) Patients with a known allergy to penicillin-class antibiotics. (2) Patients undergoing dialysis or with severe renal impairment (creatinine clearance <40 mL/min; estimation using the Cockcroft-Gault equation is permitted) for whom antibiotic dose adjustment is difficult. (3) Patients who are breastfeeding, pregnant, or may be pregnant. (4) Patients with infectious mononucleosis. (5) Patients scheduled to undergo resection of other organs simultaneously (including combined or concomitant resections). (6) Patients deemed inappropriate for participation by the investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection (SSI) within 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy Endpoints) Incidence of surgical site infections (SSI), including superficial incisional SSI, deep incisional SSI, and organ/space SSI Postoperative complications of Clavien-Dindo classification grade III or greater within 90 days after surgery Incidence of clinically relevant postoperative pancreatic fistula (ISGPS Grade B/C) Incidence of delayed gastric emptying (all ISGPS grades) Incidence of postpancreatectomy hemorrhage (ISGPS Grade B/C) Incidence of gastrointestinal anastomotic leakage Incidence of postoperative bile leakage (ISGLS Grade B/C) Length of postoperative hospital stay Mortality within 90 days after surgery Reoperation within 90 days after surgery Readmission within 90 days after surgery Incidence of infectious complications, including intra-abdominal abscess, sepsis, cholangitis, pneumonia, urinary tract infection, catheter-related infection, etc. (Safety Endpoints) Incidence of adverse events related to prophylactic antibiotics Incidence of postoperative Clostridioides difficile colitis Detection of antimicrobial-resistant organisms (e.g., ESBL-producing bacteria, CRE, MRSA, VRE, multidrug-resistant Gram-ngative bacteria) and Candida species | — |
Contacts
Public ContactTakuya Mizumoto
Kobe University Hospital
Outcome results
None listed