Preoperatively diagnosed biliary cancer
Conditions
Interventions
Bromhexine hydrochloride 4 mg, orally administered three times a day.
Treatment duration: 6 months following the completion of acute-phase treatment.
Sponsors
Ebata Tomoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older. Underwent hepatectomy combined with biliary resection and reconstruction for preoperatively diagnosed biliary cancer. Patients who can attend regular outpatient visits at our hospital for at least 8 months after registration. Patients capable of voluntary oral intake and able to take bromhexine hydrochloride. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: Patients with allergies to bromhexine hydrochloride. Patients with severe organ dysfunction, such as liver or kidney failure. Pregnant or breastfeeding women. Patients deemed unsuitable by the principal investigator. Patients unable to start bromhexine hydrochloride within 8 weeks post-surgery due to not-stabilized general condition(C-reactive protein 5 or less).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative cholangitis (number of patients with cholangitis/number of evaluable enrolled patients) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative cholangitis (number of patients with cholangitis/number of enrolled patients). Incidence of postoperative cholangitis (number of cholangitis episodes/registered patients). Readmission rate due to postoperative cholangitis. Duration of antibiotic use (total days from the first dose to the final dose for each readmission, calculated per case). Blood culture positivity rate during readmission for postoperative cholangitis:(number of patients with positive blood cultures/number of patients undergoing blood cultures, number of positive blood culture episodes/total blood culture tests performed). Details of adjuvant therapy for eligible cases: Presence or absence of S-1 initiation, Initial dose of S-1, Days from surgery to the start of S-1 administration. Factors influencing the incidence of cholangitis. External controls extracted from existing databases will be compared with the study treatment group. | — |
Contacts
Public ContactShoji Kawakatsu
Nagoya University Graduate School of Medicine
Outcome results
None listed