PancreaticojuodenectomyFerritinNCT06442111
The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy
A study testing The intravenous ferritin group in people with Pancreaticojuodenectomy, run by Seoul St. Mary's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticojuodenectomy
- What is being tested?
- The intravenous ferritin group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who diagnosed periampullary tumor
- age under 75, over 18 years
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy: A Multicenter, Randomized, Controlled Trial
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.
Read the 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
- Being tested
- The intravenous ferritin group, The placebo group
- Keywords
- Iron-deficiency anemia, Ferric carboxymaltose, perioperative outcome
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intravenous ferritin groupDrug
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 groupDrug
Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned. Receives: Drug: The intravenous ferritin group; Drug: The placebo group |
| The placebo group | Experimental | inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned. Receives: Drug: The intravenous ferritin group; Drug: The placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
Postoperative transfusion rate
Postoperative transfusion rate (%) : If blood transfusion is required within 72 hours after surgery
Measured: 12 weeks
morbidity
morbidity (%) : postoperative complications (infectious, non-infectious complications)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticojuodenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taeho Hong, Seoul St. Mary's Hospital
- Investigators
- Sung eun Park, Study director, Catholic University Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442111
- Sponsor's protocol ID
- Seoul_IDA
- Acronym
- Ferritin
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy: A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06442111
- Acronym / sponsor ID
- Ferritin / Seoul_IDA
- Conditions
- Pancreaticojuodenectomy
- Keywords
- Iron-deficiency anemia, Ferric carboxymaltose, perioperative outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Drug: The intravenous ferritin group, Drug: The placebo groupinclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned. |
| The placebo group | Experimental | Drug: The intravenous ferritin group, Drug: The placebo groupinclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who diagnosed periampullary tumor
- age under 75, over 18 years
Key exclusion criteria (6 listed)
- palliative or emergency surgery,
- incurable or metastatic disease state,
- insufficient data,
- accompanying hematologic disorders that may cause anemia,
- loss to follow-up,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intravenous ferritin groupAdminister 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) | Drug | The experimental group, The placebo group |
| The placebo groupAdminister intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery | Drug | The experimental group, The placebo group |
Primary outcome
Number of hemoglobin responders by 12 weeks after surgery
Time frame: 12 weeks
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
2 secondary outcomes
Postoperative transfusion rate
Time frame: 12 weeks
morbidity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung eun Park study director
Catholic University Seoul St. Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing The intravenous ferritin group in people with Pancreaticojuodenectomy, run by Seoul St. Mary's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae ho Hong (+82-10-5206-5266, gshth@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hemoglobin responders by 12 weeks after surgery (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.