Clinical trial NCT06712706: Effect of Feeding Jejunostomy on Sarcopenia in Patients with Esophageal Cancer
Official title: Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients with Advanced Stages of Esophageal Cancer in Curate Cancer Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Esophageal Carcinoma
Sarcopenia
Feeding Tube
Keywords: feeding jejunostomy tube
enteral feeding route before or after neoadjuvant therapy
feeding jejunostomy tube at staging laparoscopy
feeding jejunostomy in esophagel cancer
sarcopenia in esophageal cancer
effect of enteral feeding on sarcopenia
sarcopenia in esophageal cancer patients
Lead sponsor: Stadtspital Zürich
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated between 2017 and 2024 in the single institution of the City Hospital Zürich Triemli and completed a 6-month follow-up or died by 31.12.2024.

Brief summary: Participants were diagnosed with esophageal cancer needing chemo- or radiochemotherapy before the potentially curing surgery consisting of esophagectomy. At the time of diagnosis, in all participants, a laparoscopy to complete staging was performed. In some patients, a feeding jejunostomy tube (FJT) was placed at the time of staging laparoscopy; in others, the FJT was placed at the time of esophagectomy. A common risk factor for higher morbidity and mortality is sarcopenia, a condition associated with low skeletal muscle. This study aims to determine whether the timing of the FJT placement affects the progress of sarcopenia.

Detailed description: At the City Hospital Zurich Triemli, an FJT tube is inserted in approximately two-thirds of patients before commencing neoadjuvant therapy. Another third receive an FJT at the time of esophagectomy to ensure postoperative enteral feeding. To this day, no prospective, randomized study exists as to whether placing an FJT at diagnosis or esophagectomy impacts sarcopenia. Retrospectively collected data is limited due to small sample sizes and observational character.

This is a retrospective, single-center cohort study using disease-related data already collected. The study design includes statistical balancing techniques to achieve comparability between the two groups and estimate an unbiased treatment effect of the timing of FJT placement.

All data is extracted from the clinical information systems and radiological systems and is credible, protected data. It is taken exclusively from the medical records; patients are not contacted for data collection.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and above at the time of diagnosis.
* Advanced-stage esophageal cancer or cancer of the esophageal junction and treated with curative intent, including neoadjuvant treatment.
* Patients who received an FJT either before neoadjuvant treatment or during definitive surgery.

Exclusion Criteria:

* Insufficient data for analysis
* Written rejection of general consent

Primary outcomes:
measure: Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.
timeFrame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
Secondary outcomes:
measure: Major complications
timeFrame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
measure: Overall length of stay
timeFrame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Stadtspital Zürich
Study officials:
affiliation: Stadtspital Zürich
name: Stefan Gutknecht, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: