Clinical trial · Interventional

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

Impact of Enteral Feeding Approaches on Chyle Leaks in Oesophageal Cancer Surgery

NCT06965205CI-TRIAL-00089511not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Oesophageal Cancer	Esophageal Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
MCT feeding	Dietary Supplement	—	UNRESOLVED
Standard feeds	Dietary Supplement	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Standard feeds
description
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.
interventionNames
1. Dietary Supplement: Standard feeds
type
EXPERIMENTAL
label
MCT feeds
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

References

Publications (0)

Data not yet available

No reference posted for this study.