Skip to content

Antibiotic prophylaxis for Pancreatoduodenectomy with Endoscopic biliary stenting: APE trial

Randomized trial of Antibiotic prophylaxis for Pancreatoduodenectomy with Endoscopic biliary stenting: first versus third-generation cephalosporins

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220033
Enrollment
210
Registered
2022-06-15
Start date
2022-07-06
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

Pancreatic cancer or other disease that require pa ncreatoduodenectomy

Interventions

Patients will receive a first-generation cephem antibiotic (CEZ) or a third-generation cephemantibiotic (CTRX) as a perioperative antimicrobial for pancreaticoduodenectomy.

Sponsors

Sugiura Teiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who planned to undergo pancreatoduodenectomy (2) Patients who performed endoscopic biliary stenting (EBS) for obstructive jaundice

Exclusion criteria

Exclusion criteria: (1) Patients without preoperative biliary drainage (2) Patients with bacteria detected in bile culturewithin 2 weeks prior to registration (3) Patients who planed to undergo total pancreatectomy (including residual total pancreatectomy) (4) Patients who received preoperativeradiotherapy (with or without chemotherapy) (5) Patients who planed to undergo combined major hepatectomy (two or more segments)

Design outcomes

Primary

MeasureTime frame
Incidence of surgical site infection (SSI)

Secondary

MeasureTime frame
(1) Incidence of Incisional SSI (2) Incidence of Organ/Space SSI (3) Results of postoperative drainage culture (4) Results of intraoperative bile culture (5) Incidence of other infectious complications (bacteremia, respiratory tract infection, urinary tract infection, infectious enteritis, etc.) (6) Incidence of pancreatic fistulas (ISGPF criteriagrade B and C) (7) Incidence of postoperative complications of Clavien-Dindo classification grade III or higher (8) Presence, type, and number of days oftherapeutic antimicrobials administered for postoperative infections (Total days from the second day after surgery to the day of discharge) (9) Postoperative hospital stays (10) Incidence of serious adverse events

Contacts

Public ContactShinpei Otsuka

Shizuoka Cancer Center

sh.otsuka@scchr.jp+81-55-989-5222

Outcome results

None listed

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