Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442111
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-12
Brief Title:
The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy
Sponsor:
Seoul St Marys Hospital
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ferritin
Brief Summary:
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
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
Detailed Description:
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 patient39s 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
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 patient39s 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None