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Active (not recruiting) NCT06712706

Effect of Feeding Jejunostomy on Sarcopenia in Patients With Esophageal Cancer

Conditions: Esophageal Cancer Esophageal Carcinoma Sarcopenia Feeding Tube

Sponsor: Stefan Gutknecht

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Feeding jejunostomy placement
PROCEDURE
Feeding jejunostomy placement at esophagectomy
PROCEDURE
Locations 1
Switzerland (1)
Stadtspital Zürich
Zurich
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.11.2024
Completion date
30.06.2026
Registry ID
NCT06712706
Source
clinicaltrials.gov
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