Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

TERMINATED

NCT03676478

Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival

Sponsor: University Hospital, Gasthuisberg

View on ClinicalTrials.gov

Summary

The surgical stress of an esophagectomy causes a detrimental impact on the physiological response of the body. In this perspective, one could question whether the current feeding regimens of starting early nutritional support at postoperative day (POD) 1 have a similar negative impact on the muscle mass as documented in critically ill patients. This study will introduce relative starvation in the early days following esophagectomy compared to the current regimen of early enteral nutritional support. The research team aims to investigate whether the negative impact on muscle mass and muscle function might be reduced, which should result in enhanced postoperative recovery. The final result of the study will be a well-documented and scientifically substantiated nutritional regimen for patients who underwent an esophagectomy for cancer.

Official title: Assessing the Influence of Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

239

Start Date

2019-03-25

Completion Date

2025-12-02

Last Updated

2026-06-08

Healthy Volunteers

Conditions

Esophageal Cancer Nutrition Aspect of Cancer Postoperative Complications Muscle Weakness Sarcopenia Jejunostomy; Complications

Interventions

OTHER

delayed start enteral support @ POD5

instead of caloric suppletion, participants will receive mls of water over the jejunostomy feeding tube daily equivalent to the rate of increase of infusion of the control group as to preserve the same amount of fluid administration through the GI route as the control group. This is continued until POD5 12.00h when enteral feeding is started according to the incremental regimen as defined for the SOC group. During the intervention, water is used as to maximize stimulation of the enteral route, however without giving nutritional support and need to prolong iv-infusion for maintaining the fluid balance in the participants. Also subjects in this interventional arm will end up with a caloric suppletion of 1.000kCal/24h by the end of postoperative day 7.

Inclusion Criteria: * Candidates for surgical resection with a curative intent, admitted to our Department. * Able to understand the study information in Dutch or French and tasks related to the study measurements provided by the researchers. * Able to consent. * Patients with cancer of the gastroesophageal junction (GEJ), distal, mid- and proximal thoracic esophagus. * Patients with early as well as advanced clinical stage esophageal cancer: from clinical stages cT1N0 over cT2+ N+ or cT3 Nx after neo-adjuvant therapy or at the time of staging as a candidate for primary surgery. * Histology preop: Squamous or adenocarcinoma. * Patients must undergo at least two-field lymphadenectomy; three-field lymphadenectomy if deemed necessary by the clinical team is not a contraindication for inclusion. * All access: (robotic assisted) minimal invasive (thoracoscopy \& laparoscopy) approach, left thoraco-abdominal incision, hybrid esophageal resection or R thoracotomy + laparotomy * Partial or subtotal esophagectomy. * Reconstruction by gastric conduit. * All anastomoses (intrathoracic or cervical). * Women of child bearing age with esophageal cancer can be included. Exclusion Criteria: * Patients in a definitive chemoradiation protocol, or undergoing rescue resection following definitive chemoradiotherapy. * Patients expected to die within 12 hours (=moribund patients). * Patients transferred from another institute after esophageal resection with an established nutritional therapy. * Patients with a cT4b tumor after neo-adjuvant therapy. * Patients who are at the time of surgery deemed unresectable or found to be unresectable during surgery. * Patients with a R2-resection. * Patients with metastasis at the time of clinical staging. * Patients undergoing transhiatal resection of the esophagus. * Patients undergoing total gastrectomy * Patients undergoing an esophageal resection or esophageal bypass as palliative treatment * Patients with tumors in the cervical esophagus with a distance less than 3cm from the cricopharyngeal sphincter. * Patients with pharyngeal cancer undergoing (laryngo-)pharyngectomy with gastric pull-up * Need for colonic or jejunal interposition * Patients with a second synchronous malignancy * Patients with inflammatory bowel disease (as this might interfere with caloric uptake in the small bowel) * Patients with contra-indications for enteral nutrition. * Patients already participating in a study with a nutritional intervention.

Locations (1)

University Hospitals Leuven, dept. of Thoracic Surgery

Leuven, Belgium