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Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how different ways of providing nutrition affect muscle loss after a surgery called oesophagectomy. An oesophagectomy is a procedure where part or all of the esophagus, the tube that carries food from the mouth to the stomach, is removed. This surgery is often necessary for patients with certain conditions affecting the esophagus. The study will use a treatment called SmofKabiven emulsion for infusion, which is a special mixture of nutrients given directly into the bloodstream. This mixture includes various amino acids, which are the building blocks of proteins, as well as oils rich in omega-3 fatty acids, and other essential nutrients like glucose and electrolytes.

The purpose of the study is to explore how the route of nutrition impacts a condition known as cachexia, which is a type of severe muscle wasting that can occur after major surgeries like oesophagectomy. Participants in the study will receive either the SmofKabiven emulsion or a placebo. The study will observe changes in muscle size using a method called CT-scan, which is a type of imaging that allows doctors to see detailed pictures of the inside of the body. This will be done before the surgery and again 10 days after the surgery to assess any differences in muscle size.

The trial will follow participants over a period of time to gather information on how effective the SmofKabiven emulsion is in preventing muscle loss compared to other forms of nutrition. The study aims to provide valuable insights into the best nutritional strategies for patients undergoing oesophagectomy, potentially improving recovery and overall outcomes for these patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be scheduled for an elective surgery called oesophagectomy at the Department of Thoracic Surgery. This procedure involves the removal of part or all of the esophagus and may include reconstructive procedures using the stomach, duodenum, or colon.

  2. Step 2

    Pre-surgery assessment

    Before the surgery, a CT-scan will be performed to assess your muscle size. This scan will help in understanding the impact of the nutritional route on muscle wasting.

  3. Step 3

    Surgery and initial recovery

    The surgery will be performed as planned. After the surgery, you will begin the recovery process in the hospital. During this time, you will receive nutrition through one of the two methods being studied: enteral nutrition (through the digestive tract) or TPN (total parenteral nutrition, which is delivered directly into the bloodstream).

  4. Step 4

    Post-surgery monitoring

    For 10 days following the surgery, your muscle size will be monitored using another CT-scan. This will help determine any changes in muscle size and assess the effectiveness of the nutritional route.

  5. Step 5

    Completion of study participation

    After the 10-day monitoring period, your participation in the study will be complete. The data collected will contribute to understanding how different nutritional routes affect muscle wasting after oesophagectomy.

Who can join the trial?

7 criteria

  • Must be scheduled for an elective oesophagectomy. This is a planned surgery to remove part or all of the esophagus.
  • The surgery must include one of the following procedures:
    • Oesophagectomy (scopic procedure) with gastric pull-up: A surgery where the stomach is moved up to connect with the remaining esophagus.
    • Distal oesophagectomy with total gastrectomy and other reconstructive procedures (duodenum or colon): Removal of the lower part of the esophagus and the entire stomach, with reconstruction using parts of the small intestine or colon.
    • Total oesophagectomy with colon anastomosis in the neck area: Removal of the entire esophagus with reconnection using the colon in the neck area.
    • Must be eligible for both enteral and TPN nutrition. Enteral nutrition means feeding through a tube directly into the stomach or small intestine. TPN (Total Parenteral Nutrition) is feeding through a vein.
    • Must be at least 18 years old.
    • Both males and females can participate.

Who cannot join the trial?

3 criteria

  • Patients who have had an oesophagectomy cannot participate. This is a surgery to remove part or all of the esophagus, which is the tube that carries food from the mouth to the stomach.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.
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Investigated drugs

Nutrition Therapy is a treatment approach used in this trial to understand how different ways of providing nutrition can affect muscle loss after surgery for esophageal cancer. This therapy involves giving patients the nutrients they need to help their bodies recover and maintain muscle mass. The trial aims to see if the way these nutrients are given, such as through a feeding tube or regular eating, makes a difference in preventing muscle wasting.

What is already known about the treatment

Nutrition Therapy – This treatment is administered orally or through a feeding tube, depending on the patient's condition after surgery. It is currently being studied in clinical trials to understand its effects on muscle wasting, also known as cachexia, following oesophagectomy, which is the surgical removal of part or all of the esophagus. The main goal is to determine how different methods of providing nutrition can help prevent or reduce muscle loss in these patients. Nutrition therapy works by supplying essential nutrients that the body needs to maintain muscle mass and overall health, and it is classified under supportive care in pharmacology.

Investigated diseases

Cachexia – Cachexia is a complex syndrome characterized by severe body weight, fat, and muscle loss. It often occurs in patients with chronic illnesses, such as cancer or heart failure. The condition involves a significant reduction in muscle mass and strength, leading to fatigue and weakness. Cachexia progresses as the body continues to break down muscle and fat tissue, despite adequate nutritional intake. This muscle wasting is often accompanied by inflammation and metabolic changes. The progression of cachexia can severely impact physical function and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507649-27-00Estimated enrolment38 patientsSponsorAarhus University

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