Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).

Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Inclusion Criteria:

• ≥19 years old
• anticipating PD
• preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
• signed written informed consent

Exclusion Criteria:

• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
• hypersensitivity to any component of the formulation
• active severe infection/inflammation
• history of transfusion, erythropoietin, >500 mg intravenous iron administration within 4 weeks prior to screening.
• history of acquired iron overload.
• MCV > 95µm3 or TSAT > 35%
• patients with preoperative Hb<7 g/dl
• pregnancy or lactation
• decreased renal function (defined as creatinine clearance <50 L/min/1.73m2calculated by eGFR(MDRD))
• chronic liver disease or increase of liver enzymes (ALT, AST) >5 times the upper limit of normal range