Multimodal Nutritional and Sarcopenia Assessment for Risk Stratification in Lung Cancer Surgery

March 24, 2026 updated by: Caner İşevi, MD, Ondokuz Mayıs University

Prognostic Value of Multimodal Nutritional Status and Sarcopenia Assessment for Postoperative Risk Stratification in Patients Undergoing Lung Cancer Surgery: A Prospective Cohort Study

This prospective observational cohort study aims to evaluate the prognostic value of multimodal nutritional status and sarcopenia assessment in patients undergoing lung cancer surgery. Postoperative complications, mortality, and prolonged hospital stay remain major clinical concerns in thoracic surgery. Although malnutrition and sarcopenia are recognized as important determinants of surgical outcomes, their combined and multidimensional evaluation has not been sufficiently studied.

Adult patients undergoing anatomical lung resection for primary lung cancer will be included. Nutritional status will be assessed using serum biomarkers, inflammatory indices, and validated clinical nutritional scores. Sarcopenia will be evaluated using computed tomography-based muscle mass and density measurements, as well as ultrasonographic muscle thickness.

These parameters will be analyzed in relation to postoperative complications, intensive care unit (ICU) requirement, length of hospital stay, and mortality. Multivariable analyses will be performed to identify independent predictors, and a combined risk stratification model will be developed.

This study aims to improve preoperative risk assessment and to support personalized perioperative management strategies, including identification of patients who may benefit from targeted nutritional optimization and prehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-center observational cohort study will be conducted at Ondokuz Mayis University, Department of Thoracic Surgery. The study aims to investigate the combined prognostic impact of nutritional status and sarcopenia on postoperative outcomes in patients undergoing lung cancer surgery.

Postoperative morbidity and mortality remain significant concerns following lung cancer surgery. Current risk stratification approaches mainly focus on age, comorbidities, and pulmonary function, while modifiable biological factors such as nutritional status and sarcopenia are not systematically integrated into routine assessment.

In this study, nutritional status will be evaluated using serum biomarkers (including albumin and inflammatory markers), inflammatory indices such as CRP/albumin ratio, and validated clinical nutritional scores (including NRS-2002, CONUT, PNI, and NRI). Dietitian-based assessments will include bioimpedance analysis, handgrip strength, and functional performance tests.

Sarcopenia will be assessed using preoperative computed tomography (CT) by measuring skeletal muscle area, muscle density, and pectoralis muscle index. Ultrasonographic measurements of pectoral muscle thickness will also be obtained. Sarcopenia will be defined according to established international consensus criteria.

Postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and short-term mortality will be recorded. Complications will be classified using a standardized severity grading system.

Multivariable statistical analyses will be performed to identify independent predictors of adverse outcomes. The combined effect of malnutrition and sarcopenia will be evaluated, and a multimodal risk stratification model will be developed. Model performance will be assessed using discrimination and calibration metrics.

The study is expected to provide a clinically applicable and reproducible multimodal risk assessment framework. This approach may improve patient selection, support perioperative decision-making, and facilitate targeted nutritional and prehabilitation strategies in lung cancer surgery.

Study Type

Observational

Enrollment (Estimated)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Samsun
      • Samsun, Samsun, Turkey (Türkiye)
        • Recruiting
        • Ondokuz Mayis University Faculty of Medicine, Department of Thoracic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer at a tertiary thoracic surgery center will be included. All participants will be prospectively enrolled and evaluated preoperatively for nutritional status and sarcopenia using clinical, biochemical, and imaging-based assessments.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer
  • Availability of preoperative thoracic computed tomography (CT) within 30 days before surgery
  • Completion of preoperative nutritional assessment and ultrasonographic muscle measurements
  • Ability to provide written informed consent

Exclusion Criteria:

  • Receipt of neoadjuvant chemotherapy, immunotherapy, or radiotherapy
  • Emergency surgery
  • Pneumonectomy
  • Combined resection of another organ during the same procedure
  • Inadequate or non-evaluable imaging or measurement data
  • Immunosuppressive therapy or presence of advanced/metastatic disease
  • Significant thoracic deformity or prior conditions interfering with muscle measurements
  • Refusal or inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung Cancer Surgery Cohort
Adult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer will be prospectively enrolled. Preoperative nutritional status and sarcopenia will be assessed using biochemical markers, validated nutritional scores, and imaging-based muscle measurements. Patients will be followed for postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and mortality.
Other: Observational Assessment
Participants will undergo standard preoperative clinical evaluation including nutritional assessment, laboratory measurements, and imaging-based body composition analysis as part of routine care. No experimental intervention or treatment is administered. All data are collected observationally without influencing clinical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications (30-day, Clavien-Dindo classification)
Time Frame: Within 30 days after surgery
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification system. Major complications are defined as Grade III or higher. This outcome will be analyzed as both overall complication rate and major complication rate.
Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Postoperative period (up to 30 days)
Total number of days from the date of surgery to hospital discharge.
Postoperative period (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ODM.0.20.08/889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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