- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712706
Effect of Feeding Jejunostomy on Sarcopenia in Patients With Esophageal Cancer
Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients With Advanced Stages of Esophageal Cancer in Curate Cancer Treatment
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8063
- Stadtspital Zürich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube
Included are:
Patients receiving the FJT at staging laparoscopy will be compared to patients receiving FJT at the time of esophagectomy. |
Placement of feeding jejunostomy at staging laparoscopy
Other Names:
Placement of feeding jejunostomy at esophagectomy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.
Time Frame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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This will be measured by the skeletal muscle index (SMI) at three points: the first SMI is measured at the time of diagnosis, the second preoperatively at re-staging after completion of neoadjuvant therapy, and the third measurement is six months postoperatively. We expect that regular enteral feed through FJT during neoadjuvant therapy leads to higher SMI or less progress of sarcopenia compared to FJT placement at esophagectomy. |
For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Major complications
Time Frame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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Classified according to Clavien-Dindo Classification and Comprehensive complication index, CCI.
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For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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Overall length of stay
Time Frame: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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The length of stay for esophagectomy and the overall length of hospital stay from diagnosis to six months postoperatively, excluding elective hospitalizations for radiotherapy.
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For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Gutknecht, Dr. med., Stadtspital Zürich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Neoplasms by Site
- Neoplasms
- Pathological Conditions, Anatomical
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Esophageal Neoplasms
- Sarcopenia
Other Study ID Numbers
- BASEC 2024-01793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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