The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy

NCT ID: NCT06442111

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

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.

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 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.

Conditions

Pancreaticojuodenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The experimental group

inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.

Group Type: EXPERIMENTAL

The intravenous ferritin group

Intervention Type: DRUG

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)

The placebo group

Intervention Type: DRUG

Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery

The placebo group

inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.

Group Type: EXPERIMENTAL

The intravenous ferritin group

Intervention Type: DRUG

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)

The placebo group

Intervention Type: DRUG

Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery

Interventions

The intravenous ferritin 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)

Intervention Type: DRUG

The placebo group

Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients who diagnosed periampullary tumor
• age under 75, over 18 years

Exclusion Criteria

1. palliative or emergency surgery,

2. incurable or metastatic disease state,

3. insufficient data,

4. accompanying hematologic disorders that may cause anemia,

5. loss to follow-up,

6. ferritin Contraindications to intravenous administration (pregnancy or lactation, age under 18 years, history of severe asthma or infection, chronic renal failure, simultaneous oral and intravenous iron administration, allergic reaction to iron)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taeho Hong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung eun Park

Role: STUDY_DIRECTOR

Catholic University Seoul St. Mary's Hospital

Central Contacts

Tae ho Hong

Role: CONTACT

gshth@catholic.ac.kr

+82-10-5206-5266

Sung eun Park

Role: CONTACT

carin337@naver.com

+82-10-5775-9351

Other Identifiers

Seoul_IDA

Identifier Type: -

Identifier Source: org_study_id