METRONIDAZOLE for Pancreatoduodenectomy (Whipple procedure) – high risk for contaminated bile|Postoperative abdominal surgical site infection (organ/space)

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Contraindication for the study antibiotics (e.g. allergy or intolerance)"}
• {"criterion_text":"- Indication for endocarditis prophylaxis"}
• {"criterion_text":"- Preoperative planned therapeutic antibiotic treatment after surgery (i.e. for cholangitis or liver abscesses)"}
• {"criterion_text":"- A reduced renal function, defined as a eGFR of <60 ml/min/1.73m2 and measured on a the closest timepoint prior to pancreatoduodenectomy"}

Primary endpoints

• {"endpoint_text":"- To evaluate the additional value of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile (patients with preoperative biliary drainage or an ampullary malignancy).","definition_or_measurement_approach":"Clinically relevant OSI defined (based on CDC definition): • A deep surgical site infection involving any part of the abdomen other than the surgical incision within 90 days after surgery. • AND Requires radiological, endoscopic or surgical intervention OR therapeutic antibiotics required for an episode of sepsis, defined as two or more SIRS criteria. • AND Organisms isolated from an aseptically obtained culture."}

Secondary endpoints

• {"endpoint_text":"- Rate of OSIs according to the CDC definition","definition_or_measurement_approach":"Measured as OSIs according to the CDC definition within 90 days after surgery."}
• {"endpoint_text":"- Rate of isolated OSIs (OSIs without concurrent anastomotic leak)","definition_or_measurement_approach":"Isolated OSI defined as an OSI without concurrent anastomotic leakage (pancreatojejunostomy, hepaticojejunostomy or gastrojejunostomy)."}
• {"endpoint_text":"- Rate of superficial SSIs (wound infections)","definition_or_measurement_approach":"Superficial incisional SSI defined according to the CDC definition: superficial surgical site infection occurring within 30 days after surgery involving superficial or deep soft tissue and meeting CDC criteria (purulent drainage; isolation of microorganisms from aseptic culture; deliberately opened by surgeon or signs such as localized pain, tenderness, swelling, heat or fever >38°C)."}
• {"endpoint_text":"- Rate of clinically relevant POPF","definition_or_measurement_approach":"Clinically relevant postoperative pancreatic fistula defined as grade B or C according to the ISGPS definition."}
• {"endpoint_text":"- Rate of bile and enteric leak","definition_or_measurement_approach":"Measured according to the ISGLS definition."}
• {"endpoint_text":"- Rate of post pancreatectomy hemorrhage","definition_or_measurement_approach":"Measured according to the ISGPS definition for postpancreatectomy hemorrhage."}
• {"endpoint_text":"- Rate of delayed gastric emptying","definition_or_measurement_approach":"Measured according to the ISGPS definition for delayed gastric emptying."}
• {"endpoint_text":"- Rate of postoperative bacteraemia","definition_or_measurement_approach":"Defined as a positive blood culture."}
• {"endpoint_text":"- Rate of Clostridium difficile infection","definition_or_measurement_approach":"Measured as occurrence of Clostridium difficile infection postoperatively."}
• {"endpoint_text":"- Rate of major complications (Clavien-Dindo ≥III)","definition_or_measurement_approach":"Major complications defined as Clavien-Dindo score ≥III."}
• {"endpoint_text":"- Reintervention (either surgical, radiological of endoscopic)","definition_or_measurement_approach":"Any reintervention during admission: surgical, radiological or endoscopic."}
• {"endpoint_text":"- ICU admission","definition_or_measurement_approach":"ICU admission within 90 days after surgery."}
• {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Measured as length of hospital stay in days."}
• {"endpoint_text":"- Readmission","definition_or_measurement_approach":"Readmission within 90 days after surgery."}
• {"endpoint_text":"- Mortality","definition_or_measurement_approach":"In-hospital and 90-day mortality."}
• {"endpoint_text":"- Switch of postoperative antibiotics","definition_or_measurement_approach":"Switch of postoperative antibiotics including reason for deviation from antibiotic protocol."}
• {"endpoint_text":"- Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites","definition_or_measurement_approach":"Assessment of antibiotic susceptibility patterns in bile cultures and surgical site cultures."}
• {"endpoint_text":"- Concordance of microorganisms in bile and surgical site cultures","definition_or_measurement_approach":"Concordance analysis between microorganisms isolated from bile and from surgical site cultures."}
• {"endpoint_text":"- Rate of chyle leak according to the ISGPS definition.","definition_or_measurement_approach":"Measured according to the ISGPS definition for chyle leak."}

Netherlands

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

08-08-2025

Processing Time Days

427

Number Of Sites

12

Number Of Participants

458

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands