The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy

NCT06442111 | Not Yet Recruiting

• 1 other identifier: Seoul_IDA
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreaticojuodenectomy

Keywords

Iron-deficiency anemia; Ferric carboxymaltose; perioperative outcome

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

• Postoperative transfusion rate

  12 weeks

• morbidity

  12 weeks

Study Arms (2)

The experimental group

EXPERIMENTAL

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

Drug: The intravenous ferritin group; Drug: The placebo group

The placebo group

EXPERIMENTAL

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

Drug: The intravenous ferritin group; Drug: The placebo group

Interventions

The intravenous ferritin group 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 experimental group; The placebo group

The placebo group DRUG

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

The experimental group; The placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• palliative or emergency surgery,
• incurable or metastatic disease state,
• insufficient data,
• accompanying hematologic disorders that may cause anemia,
• loss to follow-up,
• 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)

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sung eun Park

  Catholic University Seoul St. Mary's Hospital

  STUDY DIRECTOR

Central Study Contacts

Tae ho Hong

CONTACT

+82-10-5206-5266; gshth@catholic.ac.kr

Sung eun Park

CONTACT

+82-10-5775-9351; carin337@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share