Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Extra-Virgin Olive Oil
Dietary supplementA 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.
Treatment groups
1,036 Participants
are divided into 2 treatment groupsGroup A: Preoperative Olive OilExperimental treatment 1 intervention
Group B: Standard Preoperative FastingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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.
Time frame
Within 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov