Effect of Feeding Jejunostomy on Sarcopenia in Patients with Esophageal Cancer

Not yet recruiting

• Conditions: Esophageal Cancer; Esophageal Carcinoma; Sarcopenia; Feeding Tube

• Registration Number: NCT06712706
• Lead Sponsor: Stefan Gutknecht

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study Start: 2024-11-30
• Study First Posted: 2024-12-02
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.	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 Outcome Measures

Name	Time	Method
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.	Classified according to Clavien-Dindo Classification and Comprehensive complication index, CCI.
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.	The length of stay for esophagectomy and the overall length of hospital stay from diagnosis to six months postoperatively, excluding elective hospitalizations for radiotherapy.

Trial Locations

Locations (1)

Stadtspital Zürich; 🇨🇭 Zürich, Switzerland