Hepatocellular CarcinomaPhase 3HCCNCT03990974
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
A Phase 3 study testing postoperative antimicrobial prophylaxis and No postoperative antimicrobial prophylaxis in people with Hepatocellular Carcinoma and Postoperative Infection, run by Sun Yat-sen University at 1 site in China.
Trial summary
This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Postoperative Infection
- What is being tested?
- postoperative antimicrobial prophylaxis and No postoperative antimicrobial prophylaxis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: over 18 years;
- Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
- Child-Pugh A class;
- No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
- No evidence of infection during preoperational assessment
Who cannot join
- Underwent hepatectomy combined with resection of other organs, except for gallbladder;
- Found obvious infection during operation;
- Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
- Allergic to the antibiotics used in the 24h before surgery;
- Emergency surgery;
- Tumor rupture;
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- Did not underwent hepatectomy because of any reasons;
- Admission to ICU after surgery;
- ASA grade ≥ 3;
- Denial of informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.
Read the detailed description
This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.
- Conditions
- Hepatocellular Carcinoma, Postoperative Infection
- Being tested
- postoperative antimicrobial prophylaxis, No postoperative antimicrobial prophylaxis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative antimicrobial prophylaxisDrug
The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
No postoperative antimicrobial prophylaxisOther
Patients will receive no antibiotics after hepatectomy unless necessary.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative antimicrobial prophylaxis | Experimental | Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy. Receives: Drug: postoperative antimicrobial prophylaxis |
| No postoperative antimicrobial prophylaxis | Sham comparator | Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection. Receives: Other: No postoperative antimicrobial prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative infection rate
the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
Measured: 30 days after hepatectomy
Secondary outcomes (4)
Surgical site infection rate
the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
Measured: 30 days after hepatectomy
Postoperative complication rate
the incidence rate of postoperative complications, grading as Clavien-Dindo grades
Measured: 3 months after hepatectomy
Severe infection rate
the incidence rate of postoperative complications over grade 3
Measured: 30 days after hepatectomy
Distant infection rate
the incidence rate of distant infections, including respiratory system infection, urinary system infection, catheter related infections or sepsis (defined as fever (temperature ≥38 ℃) or elevated white blood cell (> 10 x10^9 / L) accompanied by sputum, urine, catheter secretions, or blood culture positive.
Measured: 30 days after hepatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study startSep 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: There were difficulties in implementation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990974
- Sponsor's protocol ID
- 20190236
- Acronym
- HCC
- Status last verified
- Mar 2020
- First submitted
- 18 Jun 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
- ClinicalTrials.gov ID
- NCT03990974
- Acronym / sponsor ID
- HCC / 20190236
- Conditions
- Hepatocellular Carcinoma, Postoperative Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There were difficulties in implementation
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 19 Jun 2019 (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.
This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.
Detailed description
This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative antimicrobial prophylaxis | Experimental | Drug: postoperative antimicrobial prophylaxisPatients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy. |
| No postoperative antimicrobial prophylaxis | Sham comparator | Other: No postoperative antimicrobial prophylaxisPatients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: over 18 years;
- Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
- Child-Pugh A class;
- No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
- No evidence of infection during preoperational assessment
Key exclusion criteria (10 listed)
- Underwent hepatectomy combined with resection of other organs, except for gallbladder;
- Found obvious infection during operation;
- Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
- Allergic to the antibiotics used in the 24h before surgery;
- Emergency surgery;
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 |
|---|---|---|
| postoperative antimicrobial prophylaxisThe drugs are all common antibiotics used to prevent postoperative infection in each hospital. | Drug | Postoperative antimicrobial prophylaxis |
| No postoperative antimicrobial prophylaxisPatients will receive no antibiotics after hepatectomy unless necessary. | Other | No postoperative antimicrobial prophylaxis |
Primary outcome
30-day postoperative infection rate
Time frame: 30 days after hepatectomy
the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
4 secondary outcomes
Surgical site infection rate
Time frame: 30 days after hepatectomy
Postoperative complication rate
Time frame: 3 months after hepatectomy
Severe infection rate
Time frame: 30 days after hepatectomy
Distant infection rate
Time frame: 30 days after hepatectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing postoperative antimicrobial prophylaxis and No postoperative antimicrobial prophylaxis in people with Hepatocellular Carcinoma and Postoperative Infection, run by Sun Yat-sen University 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 5 inclusion and 10 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: paused, as of the sponsor's last update on 25 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative infection rate (time frame: 30 days after hepatectomy). 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 25 Mar 2020.