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NCT Number: NCT07807696

Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax

Chylothorax is a rare but serious complication after lung cancer surgery and mediastinal lymph node dissection. This multicenter randomized trial will evaluate whether drinking 40 mL of extra-virgin olive oil 4 hours before surgery can reduce the occurrence of chylothorax after curative lung cancer resection. A total of 1,036 adults with resectable lung cancer will be assigned in a 1:1 ratio to preoperative oral olive oil or standard preoperative fasting without additional olive oil. The primary outcome is the occurrence of chylothorax within 30 days after surgery. Secondary outcomes include repeat surgery, postoperative complications, chest drainage, length of chest tube use, length of hospital stay, and the safety and tolerability of the intervention.

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Key information

Conditions

Lung Cancer Chylothorax Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Xuhui, 200000, China

Location status: Recruiting

Location contact

Yang Zhang, MD

CONTACT

[email protected]

86-18717722753

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Voluntary participation and willing and able to complete all study procedures.
  • Age 18 to 80 years, inclusive, at informed consent.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Resectable lung cancer.
  • No prior surgery for lung cancer.
  • Treatment-naive and no prior radiotherapy or chemotherapy.
  • Able to take food orally before surgery.

Exclusion criteria

  • Allergy to olive oil or any of its components.
  • History of acute or chronic pancreatitis or severe biliary disease.
  • Fat malabsorption syndrome.
  • Prior ipsilateral thoracic surgery or thoracic radiotherapy or chemotherapy.
  • Unable to comply with preoperative dietary instructions.

Treatment and study plan

Extra-Virgin Olive Oil

Dietary Supplement

A single 40 mL dose of extra-virgin olive oil is taken orally 4 hours before curative lung cancer surgery. After ingestion, participants continue fasting from food and water until surgery.

Primary outcomes

  1. Incidence of Postoperative Chylothorax

    Time frame: Within 30 days after surgery

    Percentage of participants diagnosed with postoperative chylothorax. Chylothorax is defined as pleural drainage fluid triglycerides greater than 110 mg/dL (1.2 mmol/L) or a typical milky appearance of pleural drainage after resumption of oral dietary fat.

Secondary outcomes

  1. Incidence of Postoperative Complications

    Time frame: Within 30 days after surgery

    Percentage of participants with one or more surgery-related postoperative complications, including prolonged air leak, atrial fibrillation or other arrhythmia, postoperative bleeding, pulmonary infection, respiratory insufficiency, bronchopleural fistula, pneumothorax or atelectasis, recurrent laryngeal nerve injury, or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Hang Cao, MD

CONTACT

[email protected]

+86 18717722753

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Multicenter, Prospective, Randomized Controlled Trial of Preoperative Oral Olive Oil for the Prevention of Postoperative Chylothorax in Patients With Lung Cancer

Acronym: ECTOP-1031

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Sep 8, 2026
Registry last updated
Sep 8, 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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