Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.

Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction. - RCT on perioperative antimicrobial therapy in biliary surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001278

Enrollment

150

Registered

2008-08-01

Start date

2008-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-biliary-pancreatic diseases

Interventions

Antimicrobial prophylaxis (second-generation cephalosporin) are administered for three days in perioperative period recommended by CDC guideline as Class2. Therapeutic antimicrobial agents according t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females over 18 years old, and with hepatobiliary and pancreatic diseases who have undergone external biliary drainage (endoscopic nasobiliary drainage: ENBD or percutaneous transhepatic biliary drainage: PTBD) before operation.

Exclusion criteria

Exclusion criteria: Patients with renal dysfunction, sever liver dysfunction or a history of antimicrobial agents -induced allergy.

Design outcomes

Primary

Measure	Time frame
To compare the incidence of SSI occurrence rates within postoperative 30 days between 2 groups (therapeutic usage of antimicrobial agents treated as Class3 by CDC guideline and prophylactic usage of antimicrobial agents recommended by CDC guideline as Class2).	—

Countries

Japan

Contacts

Public ContactKunishige Okamura

Hokkaido university hospital Gastroenterological sutgery II

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026