Oesphageal CancerNCT07616245
MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy
A study testing Standard Jejunostomy Feed (Nutrison Protein Plus) and MCT-Based Jejunostomy Feed (Nutrison Peptisorb) in people with Oesphageal Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesphageal Cancer
- What is being tested?
- Standard Jejunostomy Feed (Nutrison Protein Plus) and MCT-Based Jejunostomy Feed (Nutrison Peptisorb)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIreland
- Study dates
- 2 Oct 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0
Aisling Hegarty, PhD, 018093000, Aislinghegarty@rcsi.ie
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Oesphageal Cancer
- Being tested
- Standard Jejunostomy Feed (Nutrison Protein Plus), MCT-Based Jejunostomy Feed (Nutrison Peptisorb)
- Keywords
- Robotic Oesophagectomy, Enhanced Recovery After Surgery, Oesphagectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Jejunostomy Feed (Nutrison Protein Plus)Other
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.
MCT-Based Jejunostomy Feed (Nutrison Peptisorb)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Jejunostomy Feeding | Active comparator | 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. Receives: Other: Standard Jejunostomy Feed (Nutrison Protein Plus) |
| Medium-Chain Triglyceride (MCT) Jejunostomy Feeding | Experimental | 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. Receives: Other: MCT-Based Jejunostomy Feed (Nutrison Peptisorb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 1,3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesphageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-centre, prospective, block-randomised controlled trial. Adult patients undergoing minimally invasive or robotic-assisted oesophagectomy with feeding jejunostomy placement will be randomised in a 1:1 ratio to receive either standard jejunostomy feeds or medium-chain triglyceride (MCT)-based jejunostomy feeds starting on postoperative day 1. Randomisation will be performed using block randomisation (blocks of 5). Investigators will be blinded to allocation. Patients, dietetics staff, and nursing teams cannot be blinded due to the practical administration of enteral feeds. Analysis will be conducted on an intention-to-treat basis.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616245
- Sponsor's protocol ID
- 25-11
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy
- ClinicalTrials.gov ID
- NCT07616245
- Acronym / sponsor ID
- 25-11
- Conditions
- Oesphageal Cancer
- Keywords
- Robotic Oesophagectomy, Enhanced Recovery After Surgery, Oesphagectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a single-centre, prospective, block-randomised controlled trial. Adult patients undergoing minimally invasive or robotic-assisted oesophagectomy with feeding jejunostomy placement will be randomised in a 1:1 ratio to receive either standard jejunostomy feeds or medium-chain triglyceride (MCT)-based jejunostomy feeds starting on postoperative day 1. Randomisation will be performed using block randomisation (blocks of 5). Investigators will be blinded to allocation. Patients, dietetics staff, and nursing teams cannot be blinded due to the practical administration of enteral feeds. Analysis will be conducted on an intention-to-treat basis.
| Arm | Type | Receives |
|---|---|---|
| Standard Jejunostomy Feeding | Active comparator | Other: Standard Jejunostomy Feed (Nutrison Protein Plus)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. |
| Medium-Chain Triglyceride (MCT) Jejunostomy Feeding | Experimental | Other: MCT-Based Jejunostomy Feed (Nutrison Peptisorb)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Standard Jejunostomy Feeding |
| 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. | Other | Medium-Chain Triglyceride (MCT) Jejunostomy Feeding |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Oesphageal Cancer
Recruiting
The PHARO Trial: The Incidence of Para-conduit Hernia With Closure of Hiatus Versus the Standard Approach in Robotic Oesophagectomy - A Randomised Controlled Pilot Trial
Oesphageal Cancer, Para-conduit Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Jejunostomy Feed (Nutrison Protein Plus) and MCT-Based Jejunostomy Feed (Nutrison Peptisorb) in people with Oesphageal Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof jarlath Bolger, MB, BCh, BAO, MCh, FRCSI (018093000, jarbolger@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically and Biochemically Confirmed Chylothorax (time frame: Postoperative days 1,3 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.