Esophageal CancerNCT06712706
Effect of Feeding Jejunostomy on Sarcopenia in Patients With Esophageal Cancer
An observational study of Esophageal Cancer and Esophageal Carcinoma, run by Stefan Gutknecht at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Carcinoma, Sarcopenia
- What is being tested?
- Feeding jejunostomy placement and Feeding jejunostomy placement at esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Nov 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Insufficient data for analysis
- Written rejection of general consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients With Advanced Stages of Esophageal Cancer in Curate Cancer Treatment
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.
Read the 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.
- Conditions
- Esophageal Cancer, Esophageal Carcinoma, Sarcopenia, Feeding Tube
- Being tested
- Feeding jejunostomy placement, Feeding jejunostomy placement at esophagectomy
- 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
- Medical subject headings
- Esophageal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding jejunostomy placementProcedure or surgery
Also called Early placement of FJT
Placement of feeding jejunostomy at staging laparoscopy
Feeding jejunostomy placement at esophagectomyProcedure or surgery
Also called Late placement of FJT
Placement of feeding jejunostomy at esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Feeding jejunostomy placement; Procedure: Feeding jejunostomy placement at esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.
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.
Measured: 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 (2)
Major complications
Classified according to Clavien-Dindo Classification and Comprehensive complication index, CCI.
Measured: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
Overall length of stay
The length of stay for esophagectomy and the overall length of hospital stay from diagnosis to six months postoperatively, excluding elective hospitalizations for radiotherapy.
Measured: For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start30 Nov 2024
- Primary completion31 Jan 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Gutknecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Gutknecht, Stadtspital Zürich
- Investigators
- Stefan Gutknecht, Dr. med., Principal investigator, Stadtspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712706
- Sponsor's protocol ID
- BASEC 2024-01793
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients With Advanced Stages of Esophageal Cancer in Curate Cancer Treatment
- ClinicalTrials.gov ID
- NCT06712706
- Acronym / sponsor ID
- BASEC 2024-01793
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stefan GutknechtUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube | – | Procedure: Feeding jejunostomy placement, Procedure: Feeding jejunostomy placement at esophagectomyIncluded 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Insufficient data for analysis
- Written rejection of general consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding jejunostomy placementAlso: Early placement of FJTPlacement of feeding jejunostomy at staging laparoscopy | Procedure or surgery | Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube |
| Feeding jejunostomy placement at esophagectomyAlso: Late placement of FJTPlacement of feeding jejunostomy at esophagectomy | Procedure or surgery | Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Gutknecht, Dr. med. principal investigator
Stadtspital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Esophageal Carcinoma, run by Stefan Gutknecht at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.