Assessing the influence of timing of Enteral Feeding support in Esophageal Cancer patients on muscle funcTion and Survival: a monocentric, single blinded, parallel-group, open label randomised controlled trial

niversity Hospitals Leuven (UZ Leuven)0 个研究点目标入组 300 人开始时间: 2018年11月27日最近更新: 2022年9月12日

试验速览

暂无简介。

•1. Patients with cancer of the gastroesophageal junction (GEJ), distal, mid- and proximal thoracic esophagus., older than 18 years, candidates for surgical resection with a curative intent, admitted to our Department
•2. All sexes
•3. Able to understand the study information in Dutch or French and understand tasks related to the study measurements proposed by the researchers
•4. Able to consent
•5. Patients with early as well as advanced clinical stage esophageal cancer: from cT1N0 over cT2+ N+ or cT3 Nx after neo-adjuvant therapy or at the time of staging as a candidate for primary surgery
•6. Histology preop: Squamous or adenocarcinoma
•7. Patients must undergo at least a standard two-field lymphadenectomy; three-field lymphadenectomy if deemed necessary by the clinical team is not a contraindication for inclusion
•8. All access: (robotic assisted) minimal invasive (thoracoscopy & laparoscopy) approach, left thoraco-abdominal incision, hybrid esophageal resection or R thoracotomy + laparotomy
•9. Partial or subtotal esophagectomy
•10. Reconstruction by gastric conduit
•11. All anastomoses (intrathoracic or cervical)
•12. Women of childbearing age with esophageal cancer can be included

•1. Patients in a definitive chemoradiation protocol, or undergoing rescue resection following definitive chemoradiotherapy
•2. Patients expected to die within 12 hours (=moribund patients)
•3. Patients transferred from another institute after esophageal resection with an established nutritional therapy
•4. Patients with a cT4b tumor after neo-adjuvant therapy
•5. Patients who are at the time of surgery deemed unresectable or found to be unresectable during surgery
•6. Patients with a R2-resection
•7. Patients with metastasis at the time of clinical staging
•8. Patients undergoing transhiatal resection of the esophagus
•9. Patients undergoing total gastrectomy
•10. Patients undergoing an esophageal resection or esophageal bypass as palliative treatment
•11. Patients with tumors in the cervical esophagus with a distance less than 3cm from the cricopharyngeal sphincter.
•12. Patients with pharyngeal cancer undergoing (laryngo-)pharyngectomy with gastric pull-up
•13. Need for colonic or jejunal interposition
•14. Patients with a second synchronous malignancy
•15. Patients with inflammatory bowel disease (as this might interfere with caloric uptake in the small bowel)
•16. Patients with contraindications for enteral nutrition
•17. Patients already participating in a study with a nutritional intervention

发起方

niversity Hospitals Leuven (UZ Leuven)