Design of the EFECTS Trial
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Surgery, Malnutrition, Nutrition, Enteral
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Intervention
Name: Enteral feeding
Type: Other
Overall Status
Not yet recruiting
Summary
It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.

We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.

We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- advanced cT2 N+ or cT3 Nx

- all histology

- GEJ or distal esophageal ACC

- proximal or mid SCC

- curative intent with intention to treat

- no M+

- at least two-field lymphadenectomy

- all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis

- all anastomosis (intrathoracic, cervical)

Exclusion Criteria:

- T4

- R2

- transhiatal

- pt in definitive CRT or rescue resection following definitive CRT

- palliative treatment

- tumours in cervical esophagus

- pharyngeal cancer with gastric pull-up
Location
University hospital Leuven
Leuven, Vl-Brabant, Belgium
Status: Enrolling by invitation
Start Date
February 2014
Completion Date
December 2017
Sponsors
University Hospital, Gasthuisberg
Source
University Hospital, Gasthuisberg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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