Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06712706

Effect of Feeding Jejunostomy on Sarcopenia in Patients With Esophageal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Esophageal Cancer Atrophy Digestive System Diseases Digestive System Neoplasms Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Feeding Tube Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stadtspital Zürich

Zurich, 8063, Switzerland

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding jejunostomy placement

Procedure

Placement of feeding jejunostomy at staging laparoscopy

Other names: Early placement of FJT

Feeding jejunostomy placement at esophagectomy

Procedure

Placement of feeding jejunostomy at esophagectomy

Other names: Late placement of FJT

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.

    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.

Secondary outcomes

  1. 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.

    Classified according to Clavien-Dindo Classification and Comprehensive complication index, CCI.

  2. 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.

    The length of stay for esophagectomy and the overall length of hospital stay from diagnosis to six months postoperatively, excluding elective hospitalizations for radiotherapy.

Sponsors and collaborators

Lead sponsor

Stefan Gutknecht

Other

Registry information

Official study title

Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients With Advanced Stages of Esophageal Cancer in Curate Cancer Treatment

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.