Lung Cancer, Chylothorax
Conditions
Keywords
Olive Oil, Thoracic Duct, Postoperative Complications
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTExtra-Virgin Olive Oil
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Chylothorax | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | 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. |
Countries
China
Contacts
CONTACTHang Cao, MD
Outcome results
None listed