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

NCT06965205 | Not Yet Recruiting DMC

• 1 other identifier: 25/11
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oesophageal Cancer

Keywords

Oesophageal cancer; chyle leak; MCT feed

Outcome Measures

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)

  Within first 5 post-operative days

Study Arms (2)

Standard feeds

ACTIVE COMPARATOR

Standard feeds will be with Nutrison Protein Plus 1.25kcal/ml. * 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. 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.

Dietary Supplement: Standard feeds

MCT feeds

EXPERIMENTAL

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.

Dietary Supplement: MCT feeding

Interventions

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.

MCT feeds

Standard feeds DIETARY_SUPPLEMENT

Nutrison Protein Plus 1.25kcal/ml.

Standard feeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 11, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 5, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 3 months after publication, indefinite end point.