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NCT Number: NCT07794722

Prognostic Nutritional Index and Postoperative Complications in Oncologic Surgery

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli Şehir Hastanesi

Kocaeli, Izmit, 41060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: the 90-day periods following 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.

  2. Incidence of acute kidney injury

    Time frame: 3 months postoperatively

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

  3. Wound healing

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

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

  4. Thromboembolic events

    Time frame: 30 days postoperatively

    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.

  5. Revision surgery

    Time frame: 90 days postoperatively

    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.

  6. Need for cardiopulmonary resuscitation (CPR)

    Time frame: 90 days postoperatively

    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.

  7. Intraoperative and postoperative bleeding

    Time frame: 30 days postoperatively

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

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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