NCT06712706

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2024Jun 2026

First Submitted

Initial submission to the registry

November 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

November 26, 2024

Last Update Submit

April 22, 2026

Conditions

Keywords

feeding jejunostomy tubeenteral feeding route before or after neoadjuvant therapyfeeding jejunostomy tube at staging laparoscopyfeeding jejunostomy in esophagel cancersarcopenia in esophageal cancereffect of enteral feeding on sarcopeniasarcopenia in esophageal cancer patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    For each patient the investigated period is under one year. It starts with the time of diagnosis until approximately 6 months after esophagectomy.

Study Arms (1)

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.

Procedure: Feeding jejunostomy placementProcedure: Feeding jejunostomy placement at esophagectomy

Interventions

Placement of feeding jejunostomy at staging laparoscopy

Also known as: Early placement of FJT
Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube

Placement of feeding jejunostomy at esophagectomy

Also known as: Late placement of FJT
Patients with esophageal cancer receiving neoadjuvant therapy and an jejunal feeding tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Insufficient data for analysis
  • Written rejection of general consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stadtspital Zürich

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Esophageal NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Stefan Gutknecht, Dr. med.

    Stadtspital Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

November 30, 2024

Primary Completion

January 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations