Antibiotic prophylaxis for Pancreatoduodenectomy with Endoscopic biliary stenting: APE trial

JRCT ID: jRCTs041220033

Registered date:15/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer or other disease that require pa ncreatoduodenectomy
• Date of first enrollment: 06/07/2022
• Target sample size: 210
• Study type: Interventional
• Intervention(s): Patients will receive a first-generation cephem antibiotic (CEZ) or a third-generation cephemantibiotic (CTRX) as a perioperative antimicrobial for pancreaticoduodenectomy.

Outcome(s)

• Primary Outcome: Incidence of surgical site infection (SSI)

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

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

Exclude 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)

Related Information

• Primary Sponsor: Sugiura Teiichi