MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy

May 29, 2026 updated by: Royal College of Surgeons, Ireland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  • Standard jejunostomy feeding (Nutrison Protein Plus 1.25 kcal/ml), or
  • MCT-based jejunostomy feeding (Nutrison Peptisorb 1 kcal/ml)

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:

  • Chest drain output volume
  • Requirement for re-intervention (radiological or surgical)
  • Postoperative length of stay
  • 90-day postoperative morbidity

A total of 160 participants will be enrolled. Analysis will be conducted on an intention-to-treat basis.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Prof jarlath Bolger, MB, BCh, BAO, MCh, FRCSI
  • Phone Number: 018093000
  • Email: jarbolger@rcsi.com

Study Locations

  • Ireland
    • Dublin
      • Beaumont, Dublin, Ireland, D09V2N0
        • Recruiting
        • Beaumont RCSI Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Able to provide written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Jejunostomy Feeding
Participants randomised to this group will receive standard postoperative enteral nutrition via feeding jejunostomy beginning on postoperative day 1. The standard formula used will be Nutrison Protein Plus 1.25 kcal/ml. Feed initiation and escalation will follow the institution's established enhanced recovery protocol.
Other: Standard Jejunostomy Feed (Nutrison Protein Plus)
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.
Experimental: Medium-Chain Triglyceride (MCT) Jejunostomy Feeding
Participants randomised to this group will receive medium-chain triglyceride (MCT)-based enteral nutrition via feeding jejunostomy beginning on postoperative day 1. The formula used will be Nutrison Peptisorb 1 kcal/ml. Feed initiation and escalation will follow the same protocol as the control group.
Other: MCT-Based Jejunostomy Feed (Nutrison Peptisorb)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Clinically and Biochemically Confirmed Chylothorax
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.
Postoperative days 1,3 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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