Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax

Fudan University1,036 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,036

Conditions

Lung Cancer Chylothorax

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Postoperative Chylothorax

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.

Time frame: Within 30 days after surgery

Secondary Outcomes

Incidence of Postoperative Complications

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.