Use of Different Enteral Feeds to Impact on Chyle Leaks in Oesophagectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland

About this trial

Oesophagectomy (surgery to remove a cancerous portion of the oesophagus or gullet) is the cornerstone of treating oesophageal cancer. In recent years, minimally invasive techniques, including robotic assisted oesophagectomy have been introduced. These techniques reduce stress on patients, reduce pain, reduce the length of stay in hospital after their operation, without compromising cancer outcomes (and in some cases improving cancer outcomes). Any surgery carries the risk of complications. One complication that may arise with oesophagectomy is an increase in chyle leaks. Chyle is a fluid produced by the body that helps transport nutrients from the bowel to the bloodstream to allow them to be absorbed and processed. One of the channels that transports chyle, the thoracic duct, is divided as part of an oesophagectomy. Although it is clipped to reduce the risk of chyle leak, this may still occur, in up to 25% of operations. If a chyle leak occurs, a drainage tube needs to remain in the chest for a number of days, there may be alterations in the use of feeding techniques, and in a small portion of cases, there may need to be an operation to stop a leak, or a procedure in the radiology department. The goal of this study is to see whether use of a different type of post-operative feed (medium chain triglyceride or MCT feeds) can reduce the rate of chyle leak. This is already used

to treat chyle leaks, and the question is whether using this as the routine post-operative feed can reduce rates of chyle leakage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All adults aged over 18 years undergoing MIO or RAMIO for oesophageal cancer (adenocarcinoma and squamous cell cancer) at Beaumont Hospital will be approached for inclusion.

Disqualifiers

Patients will be excluded if

They are unable to provide informed consent

They do not receive a feeding jejunostomy at or prior to their oesophagectomy

Prior or concomitant malignancy that would interfere with this protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • MCT feeding

    Dietary supplement

    MCT feeds will be initiated using Nutrison Peptisorb 1kcal/ml. Peptisorb has lower fat content, with a higher proportion of MCTs. The feeding protocol for both formulae will be the same, with equivalent rates of enteral feeding: * Day 1: if no clinical contra-indication, commence feeding either with standard or MCT feeds at 20ml/hr for 24 hours. Feeds to commence at 8am. * Day 2: if tolerating feeds continue feeds at 20ml/hr for 12 hours, then increase to 40ml/hr for 12 hours * Day 3: if tolerating feeds increase feeds to 60ml/hr and await dietician review regarding target rate and duration. By POD6, if there is no chyle leak, all patients will be given standard feeds for discharge home. For oral feeding, if patients are progressing clinically, they will have restricted fluids on POD3, with introduction of diet in each group from day 4 onwards. This allows a direct comparison of chyle leak rates for 72h of regular vs MCT enteral feeding.

  • Standard feeds

    Dietary supplement

    Nutrison Protein Plus 1.25kcal/ml.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Standard feedsActive comparator 1 intervention
Group B: MCT feedsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with a confirmed chyle leak

A milky effusion \>200ml in 24 hours upon initiation of enteral feeds AND/OR pleural fluid analysis demonstrating triglyceride level \>100mg/dL AND/OR chylomicrons in pleural fluid (at least 2 elements present to confirm chyle leak)

Time frame
Within first 5 post-operative days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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