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Prognostic Nutritional IndexNCT07794722

Prognostic Nutritional Index and Postoperative Complications in Oncologic Surgery

An observational study of Prognostic Nutritional Index, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prognostic Nutritional Index
How many people
1,500 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Mar 2026to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who met the inclusion criteria, were not excluded according to the exclusion criteria, and underwent oncologic surgery between the opening date of our hospital and the date of ethics committee approval will be included in the study.

Who may be able to join

  • Kocaeli City Hospital, all patients over 18 years old who have undergone oncologic surgery

Who cannot join

  • Patients under 18 years of age
  • Patients with a history of bone marrow suppression or hematologic malignancy
  • Patients admitted as emergency cases
  • Patients who received albumin replacement within 1 month prior to surgery (preoperative period)
  • Patients who received chemotherapy/radiotherapy within the last 1 year
  • Patients who received immunosuppressive therapy within the last 1 year
  • Patients who received blood or blood product replacement within 1 month prior to surgery (preoperative period)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kocaeli Şehir Hastanesi

    Kocaeli, Izmit, 41060

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Relationship Between Prognostic Nutritional Index and Postoperative Complications in Patients Undergoing Oncologic Surgery: A Retrospective Cohort Study

Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Although PNI has been studied in various malignancies, its predictive value for postoperative outcomes across all oncologic surgical procedures has not been fully evaluated. This study aims to assess the role of PNI in predicting postoperative outcomes and prognosis in patients undergoing different types of oncologic surgery.

Read the detailed description

Anorexia, malnutrition, and cachexia are commonly observed in patients undergoing oncologic surgery . Although these issues are more pronounced in advanced-stage disease, they can also occur in early-stage malignancies and adversely affect treatment outcomes. Various methods and tests are used to assess patients' nutritional status, including the Malnutrition Universal Screening Tool (MUST) for community screening, the Nutritional Risk Screening (NRS) for hospitalized patients, and the Mini Nutritional Assessment (MNA) for elderly patients. Some of these tools are simple, consisting of only a few parameters, while others are more complex, incorporating clinical, laboratory, and technological measurements . Examples of these scales include the Subjective Global Assessment (SGA) and the Patient-Generated Subjective Global Assessment (PG-SGA) . Nutritional assessment methods have generally been reported to be useful in predicting treatment response, tolerance, and prognosis.

One such tool, the Prognostic Nutritional Index (PNI), was first proposed by Onodera et al. as a novel prognostic score based on systemic inflammation, calculated using the combination of lymphocyte count and serum albumin levels. PNI is relatively simple, relies on fewer parameters, and is easy to apply . It is calculated using the formula:

PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])

Onodera et al. demonstrated that PNI values above 45 can be used reliably, although the optimal cut-off value may vary . Hypoalbuminemia is an independent predictor of in-hospital and long-term adverse outcomes . Serum albumin (SA) is a negative marker of inflammation, as its concentration decreases in the presence of inflammatory processes . It also serves as an abundant and important circulating antioxidant, participating in ligand binding and free radical scavenging activities . Lymphocyte count reflects immune function; low lymphocyte levels have been associated with pre-existing immunosuppression, leading to inadequate immune responses in cardiovascular diseases. Patients with lymphopenia are more likely to develop endothelial dysfunction, platelet activation, and thrombogenesis. Total lymphocyte count (TLC) is an immuno-inflammatory biomarker, and lymphopenia is more likely to develop in the setting of inflammation-associated lymphocyte apoptosis .

PNI has been used as a prognostic marker in various malignancies, pulmonary embolism, and other diseases. It has been shown to be an effective indicator of nutritional and immunological status in cancer patients and to influence patient prognosis through local immune responses . Although the predictive value of PNI has been studied for postoperative mortality, treatment response, and prognosis in different oncologic surgeries, there is no study evaluating its prognostic role across all patients undergoing oncologic surgery . This study aims to assess the impact of PNI on postoperative outcomes in patients undergoing various oncologic surgical procedures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery.

    The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 30-day and 90-day mortality will be evaluated in patients undergoing oncologic surgery.

    Measured: the 30-day periods following oncologic surgery

Secondary outcomes (7)
  1. The Prognostic Nutritional Index (PNI) may be a predictor of 90-day mortality in patients undergoing oncologic surgery.

    The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery.

    The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery.

    Measured: the 90-day periods following oncologic surgery

  2. Incidence of acute kidney injury

    Predictive value of preoperative PNI for the incidence of acute kidney injury within 3 months after oncologic surgery.

    Measured: 3 months postoperatively

  3. Wound healing

    The predictive value of preoperative PNI for wound healing will be evaluated, based on assessments documented in outpatient clinic and ward notes.

    Measured: 90 days postoperatively(assessed via outpatient and ward follow-up notes)

  4. Thromboembolic events

    The predictive value of preoperative PNI for the risk of thromboembolic events within 30 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Measured: 30 days postoperatively

  5. Revision surgery

    The predictive value of preoperative PNI for the need for revision surgery within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Measured: 90 days postoperatively

  6. Need for cardiopulmonary resuscitation (CPR)

    The predictive value of preoperative PNI for the need for cardiopulmonary resuscitation within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Measured: 90 days postoperatively

  7. Intraoperative and postoperative bleeding

    The predictive value of preoperative PNI for the risk of intraoperative and postoperative bleeding will be evaluated in patients undergoing oncologic surgery.

    Measured: 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study start29 Mar 2026
  3. Primary completion10 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07794722
Sponsor's protocol ID
KSH-ERK-1
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prognostic Nutritional Index, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).

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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery. (time frame: the 30-day periods following oncologic surgery). 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 31 Aug 2026.

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