Prophylactic antibiotics to prevent surgical infections after hepatobiliary surgery in high-resistance settings
Official title: Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07620223 · Data updated 2026-11-12
This study tests whether giving piperacillin-tazobactam before surgery can reduce surgical site infections in adults undergoing hepatobiliary operations in areas with high antibiotic resistance, compared with the standard cefuroxime approach.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 378 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | May 24, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | January 31, 2029 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07620223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) scheduled for elective hepatobiliary surgery without beta-lactam allergy and without major hepatic/renal impairment, who can consent.
✕Probably not a fit
Patients with beta-lactam allergies, unconstrained preoperative infections, severe organ dysfunction, or other contraindications may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In settings with high antimicrobial resistance, this pragmatic trial compares two preoperative antibiotic strategies for hepatobiliary surgery. Patients receive either piperacillin-tazobactam or the standard cefuroxime for perioperative infection prevention. The study aims to see if the broader beta-lactam/beta-lactamase inhibitor combination lowers surgical site infection rates without introducing undue safety concerns. Eligibility includes adults undergoing elective hepatobiliary surgery who can provide informed consent. Exclusions apply to beta-lactam allergies, active preoperative infections, certain immunosuppressive treatments, organ failure, pregnancy, and concurrent trial participation.
Why it matters
Potential benefit: If successful, patients may have a lower risk of postoperative infections and related complications after hepatobiliary surgery.
How similar studies have gone: Prior evidence in high-resistance settings suggests prophylactic regimens can influence SSI rates, but this exact comparison in hepatobiliary surgery is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged ≥18 years; * Deemed eligible for elective hepatobiliary surgery; * Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures; * Capable of providing written informed consent. Exclusion Criteria: * History of β-lactam allergy or hypersensitivity * Uncontrolled preoperative infection; * Current or recent (within the preceding month) systemic corticosteroid administration; * Severe hepatic or renal impairment; * Pregnancy or lactation; * Concurrent enrolment in another clinical trial; * Any other condition deemed by the investigator to render the patient unsuitable for study participation.
Where it's running
-
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Dayu Chen, Pharmacist in Charge, PharmD
- Email: cdy_pharmacy@njglyy.com
- Phone: +86-025-83106666-60924
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How ALPPS surgery affects liver regrowth after major liver cancer operations
This project will follow adults with liver cancer who undergo ALPPS surgery to see if the quickly regrown liver tissue works well and how that relates to cancer coming back.
-
High-resolution imaging to check if tumors are completely removed during surgery
This study is testing if high-resolution imaging during surgery can help make sure all tumors are removed in patients with different types of cancer, like breast, prostate, and thyroid, to improve their treatment outcomes.
-
Exploring genetic mutations linked to liver cancers and cholestatic diseases
This study is looking to see if certain genetic changes are more common in people with liver cancers and cholestatic diseases to help understand these conditions better.
-
Observational study on durvalumab treatment for liver cancers
This study is trying to see how well a treatment called durvalumab works for people with advanced liver cancers that can’t be surgically removed.
-
Navigating Care for Liver Cancer Patients
This study is trying to learn about the experiences of liver cancer patients to create a better support program that helps them and their families manage their care.
-
Comparing blood samples from cancer-draining veins to standard veins in patients with liver and pancreatic cancers
This study is testing if taking blood samples from veins near liver and pancreatic tumors can help find cancer DNA better than using regular veins in patients getting biopsies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.