MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy
ConditionOesphageal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of oesophageal cancer (adenocarcinoma or squamous cell carcinoma)
Planned minimally invasive or robotic-assisted oesophagectomy (MIO or RAMIO) with curative intent
Placement of feeding jejunostomy at or prior to oesophagectomy
Disqualifiers
Inability to provide informed consent
No feeding jejunostomy placed at or prior to surgery
Prior or concomitant malignancy that would interfere with study protocol or outcomes
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Jejunostomy Feed (Nutrison Protein Plus)
Other interventionPostoperative 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.
MCT-Based Jejunostomy Feed (Nutrison Peptisorb)
Other interventionPostoperative 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Standard Jejunostomy FeedingActive comparator 1 intervention
Group B: Medium-Chain Triglyceride (MCT) Jejunostomy FeedingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Clinically and Biochemically Confirmed Chylothorax
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.
Time frame
Postoperative days 1,3 and 5Sponsors and contacts
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Source ClinicalTrials.gov