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临床试验/NCT06965205
NCT06965205尚未招募不适用

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

Royal College of Surgeons, Ireland0 个研究点目标入组 160 人开始时间: 2025年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
主要终点
Number of patients with a confirmed chyle leak

研究概览

简要总结

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.

详细描述

What is the purpose of the study? 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.

What will happen during the study? The oesophagectomy will proceed as planned. As part of all minimally invasive oesophagectomies, a feeding tube will be placed into the small bowel (feeding jejunostomy). This will be used to support feeding and nutrition in the post-operative period. As standard, the investigators also place a drainage tube in the right chest to drain fluid post-operatively. If the patient is recovering well, the investigators will begin feeding on the first day post-operative day. This will either be with the currently used feed (Nutrison Protein Plus) or with the MCT feed (Nutrison Peptisorb). If progressing well, oral intake will be introduced slowly from the third post-operative day. The investigators will measure the volume of fluid draining from the post-operative drain and analyse it in the lab to determine if there is a post-operative chyle leak. Should a chyle leak occur, it will be treated as per our usual protocol, which may include using alternative jejunostomy feeds, intravenous feeding (total parenteral nutrition), a procedure in radiology, or a repeat operation. All patients will be transitioned back to standard feeds for discharge.

Currently, unless contra-indicated (eg a feeding jejunostomy has not been placed), patients post MIO/RAMIO will commence percutaneous enteral feeds on the first post-operative day using a standardized enteral feeding formulation (Nutrison Protein Plus 1.25kcal/ml at 20ml/hr for 24 hours). This is then sequentially progressed until the patient is at their goal rate to meet their caloric and nutritional requirements. If there are no contraindications, PO intake commences on the 3rd post-operative day with restricted PO fluids, followed by progressive introduction of PO intake, as per our standard post-operative protocols.

Our hypothesis is, that by switching the enteral feed from standard feed to an MCT feed, this will reduce the production of chyle, allowing lymphatics to seal, and reduce the incidence of chylothorax post MIO/RAMIO.

This is a prospective randomized controlled trial. The sample size is 148 patients (72 each in intervention and control groups). The principal investigators (JB and WR) will be blinded to which feed patients are receiving. Due to the practicalities of administering jejunostomy feeds, the clinical dietetics service, nursing service and the non-consultant medical staff will not be blinded to the interventions. Due to the need to instigate training for home feeding, patients will not be blinded to the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Standard feeds (Dietary Supplement)

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.

干预措施: MCT feeding (Dietary Supplement)

结局指标

主要结局

Number of patients with a confirmed chyle leak

时间窗: Within first 5 post-operative days

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)

次要结局

未报告次要终点

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

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