Clinical trial · Interventional
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
NCT03990974CI-TRIAL-00044254HCCsuspendedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There were difficulties in implementation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Postoperative Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No postoperative antimicrobial prophylaxis | Other | — | UNRESOLVED |
| postoperative antimicrobial prophylaxis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Postoperative antimicrobial prophylaxis
- description
- Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
- interventionNames
- Drug: postoperative antimicrobial prophylaxis
- type
- SHAM_COMPARATOR
- label
- No postoperative antimicrobial prophylaxis
- description
- Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.
- interventionNames
- Other: No postoperative antimicrobial prophylaxis
Primary outcomes (1)
- measure
- 30-day postoperative infection rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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; * Did not underwent hepatectomy because of any reasons; * Admission to ICU after surgery; * ASA grade ≥ 3; * Denial of informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.