Assessing timing of enteral feeding support in esophageal cancer patients on muscle function and survival

Not Applicable

• Conditions: Patients after esophagectomy for cancer; Surgery

• Registration Number: ISRCTN14233442
• Lead Sponsor: niversity Hospitals Leuven (UZ Leuven)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-27
• Last Update Posted: 12 September 2022
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified