Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
NCT Number: NCT07616245
Chyle leak (chylothorax) is a recognised complication following minimally invasive oesophagectomy for oesophageal cancer and may result in prolonged hospital stay, nutritional compromise, and need for additional interventions.
Medium-chain triglyceride (MCT) feeds reduce lymphatic flow as they are absorbed directly via the portal circulation rather than through the thoracic duct. While MCT feeds are commonly used in the management of established chyle leaks, their role in prevention has not been evaluated in a randomised controlled trial.
This single-centre randomised controlled trial will evaluate whether initiating postoperative jejunostomy feeding with MCT-based enteral nutrition reduces the incidence of clinically and biochemically confirmed chyle leak compared with standard enteral feeding in patients undergoing minimally invasive or robotic-assisted oesophagectomy.
Participants will be randomised in a 1:1 ratio to receive either MCT-based feeds or standard jejunostomy feeds starting on postoperative day 1. The primary outcome is the incidence of chylothorax. Secondary outcomes include chest drain output, re-intervention rates, and length of hospital stay.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
Oesophagectomy is a key component of curative treatment for oesophageal cancer. Minimally invasive and robotic-assisted techniques are increasingly used and are associated with improved postoperative recovery. However, these approaches may be associated with a higher incidence of postoperative chyle leak due to extensive mediastinal lymphatic dissection.
Chylothorax occurs when the thoracic duct or its tributaries are disrupted, resulting in leakage of lymphatic fluid into the pleural cavity. This complication can lead to prolonged hospitalisation, nutritional depletion, immunosuppression, and may require radiological or surgical intervention.
Standard postoperative care includes initiation of jejunostomy feeding on postoperative day 1 using enteral formulations containing long-chain triglycerides. These lipids are absorbed via chylomicron formation and transported through the lymphatic system, potentially increasing thoracic duct flow and chyle production.
Medium-chain triglycerides (MCTs), in contrast, are absorbed directly into the portal venous system and bypass the lymphatic circulation. MCT-based feeds are widely used in the management of established chyle leaks, but their prophylactic use has not been evaluated in prospective randomised studies.
This study is a prospective, single-centre, randomised controlled trial conducted at Beaumont Hospital. Adult patients undergoing minimally invasive or robotic-assisted oesophagectomy with placement of a feeding jejunostomy will be eligible for inclusion.
Participants will be randomised in a 1:1 ratio to receive either:
Enteral feeding will commence on postoperative day 1 and follow an identical escalation protocol in both groups.
The primary endpoint is the incidence of clinically and biochemically confirmed chylothorax, defined according to Esophageal Complications Consensus Group criteria.
Secondary endpoints include:
A total of 160 participants will be enrolled. Analysis will be conducted on an intention-to-treat basis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Postoperative enteral feeding using a standard long-chain triglyceride-based jejunostomy formula (Nutrison Protein Plus 1.25 kcal/ml), initiated on postoperative day 1 and escalated according to institutional feeding protocol.
Postoperative enteral feeding using a medium-chain triglyceride-based jejunostomy formula (Nutrison Peptisorb 1 kcal/ml), initiated on postoperative day 1 and escalated according to institutional feeding protocol.
Time frame: Postoperative days 1,3 and 5
Proportion of participants developing chylothorax following minimally invasive or robotic-assisted oesophagectomy.
Chylothorax will be defined according to Esophageal Complications Consensus Group criteria as:
Milky pleural effusion >200 mL in 24 hours after initiation of enteral feeding and/or
Pleural fluid triglyceride level >100 mg/dL and/or
Presence of chylomicrons in pleural fluid
At least two diagnostic criteria must be present to confirm chylothorax.
Diagnosis will be based on pleural fluid analysis collected on postoperative days 1, 3, and 5.
Contact information is provided by the study sponsor or research team.
Royal College of Surgeons, Ireland
Other
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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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