MedDataX Logo

Effect of Feeding Jejunostomy on Sarcopenia in Patients with Esophageal Cancer

NCT ID: NCT06712706

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer Esophageal Carcinoma Sarcopenia Feeding Tube

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube

Included are:

* 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 before neoadjuvant treatment or during definitive surgery.
* Patients treated between 2017 and 2024 in the single institution of the City Hospital Zürich Triemli and completed 6 months of follow-up or died by 31.12.2024.

Patients receiving the FJT at staging laparoscopy will be compared to patients receiving FJT at the time of esophagectomy.

Feeding jejunostomy placement

Intervention Type PROCEDURE

Placement of feeding jejunostomy at staging laparoscopy

Feeding jejunostomy placement at esophagectomy

Intervention Type PROCEDURE

Placement of feeding jejunostomy at esophagectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Feeding jejunostomy placement

Placement of feeding jejunostomy at staging laparoscopy

Intervention Type PROCEDURE

Feeding jejunostomy placement at esophagectomy

Placement of feeding jejunostomy at esophagectomy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Early placement of FJT Late placement of FJT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stefan Gutknecht

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stefan Gutknecht

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Gutknecht, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Stadtspital Zürich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stadtspital Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stefan Gutknecht, Dr. med.

Role: CONTACT

[email protected]
+41444164309

Katharina L. Lucas

Role: CONTACT

[email protected]
+41782004673

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stefan Gutknecht, Dr. med.

Role: primary

[email protected]
+41444164309

Katharina L. Lucas

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BASEC 2024-01793

Identifier Type: -

Identifier Source: org_study_id