Hepatobiliary SurgeryPASHNCT07620223
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings
A study testing Piperacillin-tazobactam in people with Hepatobiliary Surgery and Prophylactic Antibiotics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatobiliary Surgery, Prophylactic Antibiotics
- What is being tested?
- Piperacillin-tazobactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yao Du, Pharmacist in Charge, +86-025-83106666-60910, dudu0083@126.com
Dayu Chen, PharmD
About this study
Official title: Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
Read the detailed description
Given the high incidence of postoperative surgical site infections (SSI) potentially attributable to bacterial antimicrobial resistance, the use of beta-lactam/beta-lactamase inhibitor combinations for prophylaxis may reduce SSI rates following hepatobiliary surgery in the current era of high antimicrobial resistance. To test this hypothesis, we propose a prospective pragmatic trial comparing piperacillin-tazobactam with the standard prophylactic regimen of cefuroxime for perioperative infection prevention in patients undergoing hepatobiliary surgery.
- Conditions
- Hepatobiliary Surgery, Prophylactic Antibiotics
- Being tested
- Piperacillin-tazobactam
- Keywords
- Hepatobiliary Surgery, Antimicrobial resistance, Prophylactic antibiotic, Surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-tazobactamDrug
Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Participants in the cotrol group will receive cefuroxime for prophylactic antibiotic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Receives: Drug: Piperacillin-tazobactam |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with surgical site infection within 30 days after surgery
The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Measured: 30 days after the surgery
Secondary outcomes (6)
30-day mortality
Measured: 30 days after the surgery
Number of Participants with Sepsis within 30 days after surgery
Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287).
Measured: 30 days after the surgery
Number of Participants with Postoperative bile leak or pancreas fisula
Postoperative bile leak and pancreas fisula was assessed by the treating surgeons.
Measured: 30 days after surgery
Postoperative hospital stay
Measured: Length of postoperative hospital stay from date of surgery until the date of first documented date of discharge from any cause, whichever came first, assessed up to 90 days.
Number of participants with infections other than surgical site infection
Infection was assessed by the treating surgeons.
Measured: Other infections occurred within 30 days after surgery.
Number of Participants with unplanned readmission and secondary surgery
Measured: Unplanned readmission and secondary surgery within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start24 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary SurgeryStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-centre, prospective, open-label, randomised pragmatic trial evaluating the efficacy of piperacillin-tazobactam as a perioperative prophylactic antimicrobial agent for the prevention of surgical site infection following hepatobiliary surgery in a high antimicrobial resistance setting. Participants in the intervention arm receive piperacillin-tazobactam for perioperative prophylaxis, whereas those in the control arm receive cefuroxime.
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Dayu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620223
- Sponsor's protocol ID
- 2026-0252-02, 2026-0452-03
- Acronym
- PASH
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07620223
- Acronym / sponsor ID
- PASH / 2026-0252-02, 2026-0452-03
- Conditions
- Hepatobiliary Surgery, Prophylactic Antibiotics
- Keywords
- Hepatobiliary Surgery, Antimicrobial resistance, Prophylactic antibiotic, Surgical site infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 24 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
Detailed description
Given the high incidence of postoperative surgical site infections (SSI) potentially attributable to bacterial antimicrobial resistance, the use of beta-lactam/beta-lactamase inhibitor combinations for prophylaxis may reduce SSI rates following hepatobiliary surgery in the current era of high antimicrobial resistance. To test this hypothesis, we propose a prospective pragmatic trial comparing piperacillin-tazobactam with the standard prophylactic regimen of cefuroxime for perioperative infection prevention in patients undergoing hepatobiliary surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-centre, prospective, open-label, randomised pragmatic trial evaluating the efficacy of piperacillin-tazobactam as a perioperative prophylactic antimicrobial agent for the prevention of surgical site infection following hepatobiliary surgery in a high antimicrobial resistance setting. Participants in the intervention arm receive piperacillin-tazobactam for perioperative prophylaxis, whereas those in the control arm receive cefuroxime.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Piperacillin-tazobactamParticipants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin-tazobactamParticipants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Participants in the cotrol group will receive cefuroxime for prophylactic antibiotic. | Drug | Intervention Group |
Primary outcome
Number of participants with surgical site infection within 30 days after surgery
Time frame: 30 days after the surgery
The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
6 secondary outcomes
30-day mortality
Time frame: 30 days after the surgery
Number of Participants with Sepsis within 30 days after surgery
Time frame: 30 days after the surgery
Number of Participants with Postoperative bile leak or pancreas fisula
Time frame: 30 days after surgery
Postoperative hospital stay
Time frame: Length of postoperative hospital stay from date of surgery until the date of first documented date of discharge from any cause, whichever came first, assessed up to 90 days.
Number of participants with infections other than surgical site infection
Time frame: Other infections occurred within 30 days after surgery.
Number of Participants with unplanned readmission and secondary surgery
Time frame: Unplanned readmission and secondary surgery within 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piperacillin-tazobactam in people with Hepatobiliary Surgery and Prophylactic Antibiotics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dayu Chen, Pharmacist in Charge, PharmD (+86-025-83106666-60924, cdy_pharmacy@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with surgical site infection within 30 days after surgery (time frame: 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.