Effect of Feeding Jejunostomy Placement on Sarcopenia in Patients With Advanced Stages of Esophageal Cancer in Curate Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Insufficient data for analysis
- •Written rejection of general consent
研究组 & 干预措施
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.
干预措施: Feeding jejunostomy placement (Procedure)
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.
干预措施: Feeding jejunostomy placement at esophagectomy (Procedure)
结局指标
主要结局
Quantification of the effect of timing of FJT placement on sarcopenia in patients with advanced stages of esophageal cancer in curative cancer treatment.
时间窗: 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.
次要结局
- 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.)
研究者
Stefan Gutknecht
Principal Investigator
Stadtspital Zürich