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

NCT07500376 | Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/889
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Malnutrition Severe; Lung Cancer (Non-Small Cell)

Keywords

lung cancer surgery; sarcopenia; nutritional status; malnutrition; risk stratification

Outcome Measures

Primary Outcomes (1)

• Postoperative complications (30-day, Clavien-Dindo classification)

  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 Outcomes (1)

• Length of hospital stay

  Postoperative period (up to 30 days)

Study Arms (1)

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

Interventions

Observational Assessment OTHER

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.

Lung Cancer Surgery Cohort

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University Faculty of Medicine, Department of Thoracic Surgery

Samsun, Samsun, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Caner İşevi, MD

CONTACT

+903623121919; drcanerisevi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)