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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Hang Cao, MD
16301050173@fudan.edu.cn
+86 18717722753
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 1036
Treatments
Experimental: Preoperative Olive Oil
Participants drink 40 mL of extra-virgin olive oil 4 hours before surgery and then continue fasting from food and water until surgery.
No_intervention: Standard Preoperative Fasting
Participants follow each center's standard preoperative fasting regimen: no food for 8 hours and no water for 2 hours before surgery. No additional olive oil is given.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov