The additional value of prolonged antibiotics after pancreatic head surgery to reduce the rate of postoperative infections

Phase 1

• Conditions: Pancreatic head malignancy; MedDRA version: 21.0Level: LLTClassification code 10033614Term: Pancreatic carcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10026319Term: Malignant neoplasm of pancreatic ductSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10008597Term: Cholangiocarcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-003217-11-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

•Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy.
•Age >18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

•Pregnancy
•Contraindication for the study antibiotics (e.g. allergy or intolerance)
•Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified