An interventional study of The intravenous ferritin group and The placebo group in Pancreaticojuodenectomy, sponsored by Seoul St. Mary's Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Treatment
Iron deficiency anemia is well known as a risk factor that worsens postoperative morbidity and patient prognosis. Several studies have shown that intravenous iron administration before surgery is effective in reducing the risk of iron deficiency anemia and improving the postoperative prognosis. However, the risk of iron deficiency anemia after surgery is increased due to the resection of the duodenum, the main organ for iron absorption. Very few studies have been conducted on the postoperative effects of higher pancreatoduodenectomy.
Observe changes in hematological parameters in patients who underwent pancreaticoduodenectomy due to periampullary tumor and confirm the role of intravenous iron supplementation in optimizing postoperative recovery.
Iron deficiency anemia (IDA) has multifactorial causes, including bleeding, insufficient iron absorption, and anemia related to malignant tumors or chronic diseases, which are cytokine-mediated diseases, and is a disease commonly observed in cancer patients. Since cancer surgery generally involves wide resection and tissue manipulation for radical lymph node dissection, systemic inflammation may occur after surgery. This may increase the risk of IDA in patients undergoing surgery by inducing a key regulator of systemic iron hemostasis that impairs intestinal iron absorption.
Pancreaticoduodenectomy, a representative surgery for periampullary neoplastic lesions, is a major surgery accompanied by moderate bleeding and large-scale tissue damage, which predisposes to IDA, and is highly likely to be accompanied by severe bleeding and blood transfusion. The perioperative blood transfusion rate has decreased with the advancement of surgical instruments and techniques, but still remains high at up to 60%. Moreover, since pancreaticoduodenectomy inevitably removes the duodenum, which absorbs iron into the body, the iron absorption function is physiologically impaired, making the patient vulnerable to IDA. Additionally, after pancreaticoduodenectomy, oral intake is often lacking for a relatively long period of time due to complex anastomosis. Therefore, the risk of IDA after pancreaticoduodenectomy may be very high regardless of the presence or absence of preoperative anemia.
IDA is a well-known risk factor for postoperative morbidity and poor prognosis of postoperative patients, and allogeneic transfusion to correct anemia is associated with an increased risk of developing infectious and non-infectious complications, including cancer recurrence, cardiac complications, and prolonged hospitalization. Available.
Research results are currently being published showing that correcting anemia through preoperative intravenous iron injection can improve the patient\'s postoperative prognosis. In the field of colon or heart surgery, the effect of preventing the occurrence of IDA in people diagnosed with IDA before surgery has been reported. In particular, in patients with postoperative anemia, serum hemoglobin, ferritin, and transferrin saturation levels improved rapidly, and indiscriminate blood transfusion was prevented. Another study showed that it was effective in reducing postoperative blood transfusion and intensive care unit length of stay in elderly patients. However, there is a lack of research on the effect of preoperative iron injections on postoperative clinical outcomes after pancreatoduodenectomy, where most patients are elderly and have high intraoperative bleeding.
Therefore, the purpose of this study was to evaluate changes in hematological parameters in patients who underwent pancreaticoduodenectomy due to periampullary lesions and their effect on improving clinical outcomes within 12 weeks after surgery.
660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.
Drug: The intravenous ferritin group · Drug: The placebo group
inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.
Drug: The intravenous ferritin group · Drug: The placebo group
Administer intravenous ferritin approximately 3-7 days before surgery (0.9% normal saline 250ml + 1000 mg of ferric carboxymaltose \[Ferinject™, Vifor Pharma, Glattbrugg, Dwitzerland\], inject over 15 minutes)
Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery
Number of hemoglobin responders by 12 weeks after surgery
If your hemoglobin level increases from baseline to week 12 by more than 2 g/dL or 14 and your hemoglobin level is more than 11 g/dL
Time frame: 12 weeks
Postoperative transfusion rate
Postoperative transfusion rate (%) : If blood transfusion is required within 72 hours after surgery
Time frame: 12 weeks
morbidity
morbidity (%) : postoperative complications (infectious, non-infectious complications)
Time frame: 12 weeks
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Plan to share: No
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This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Seoul St. Mary's Hospital