Health Condition 1: K830- Cholangitis
Conditions
Interventions
Intervention1: Short course of antibiotics (Type and route of administration will be decided by treating physician): Antibiotics shall be continued for 4 days and patients should be fulfilling all the
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with age18 years or older. 2. Patients diagnosed as having moderate to severe acute cholangitis according to Tokyo guidelines 2018. 3. Patients underwent successful biliary drainage via procedures like ERCP, EUS-guided drainage and PTBD.
Exclusion criteria
Exclusion criteria: 1. The patients not willing to participate in the study. 2. When incomplete biliary drainage is suspected (Patient with primary sclerosing cholangitis or portal cavernoma cholangiopathy with multiple intrahepatic biliary stricture or complex hilar stricture like Bismuth type III or IV). 3. Moribund patient like patients requiring ventilatory support or patients with Glasgow coma scale of less 8. 4. Patients with associated or cholangitis related complication which requires longer antibiotics (like liver abscess, acute cholecystitis or metastatic complications like infective endocarditis, pneumonia or septic arthritis at the time of diagnosis). 6. Immunocompromised patients like patients who receiving cancer chemotherapy, steroids (Prednisolone >10mg/d), or immunosuppressive agents. 7. Blood or bile culture grew fungus. 8.Patients with concomitant acute pancreatitis and other infections elsewhere in the body which requires longer hospitalization and/or antibiotics. 9. Pregnant females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure at 30 days after successful biliary drainage. (Clinical cure will be defined as absence of recurrence of cholangitis at day 30 and more than 50% reduction of bilirubin compared to initial level at week 2)Timepoint: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events due to antibiotics including antibiotic associated diarrhea, Clostridium difficile infection.Timepoint: Day 30;All-cause mortality at day 30 after the successful biliary drainageTimepoint: Day 30;Total days of antibiotics required in both the arms till 30 days after successful biliary drainage Timepoint: Day 30;Total days of hospitalization required in both the arms till 30 days after successful biliary drainageTimepoint: Day 30 | — |
Countries
India
Contacts
Public ContactJimil Shah
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Outcome results
None listed