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NCT02017366 Clinical Trial

Design of the EFECTS Trial

Esophageal Cancer Clinical Trial

— EFECTS  

Official title:
Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02017366
Other study ID # EFECTS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date April 2022

Study information
Verified date November 2023
Source University Hospital, Gasthuisberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2022
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Enteral feeding
Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

Locations
Country Name City State
Belgium University hospital Leuven Leuven Vl-Brabant

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival from day of surgery overall survival at 5 years after esophagectomy 5 years postoperative
Secondary postoperative weight loss weight loss will be calculated by using age- and gender corrected BMI percentiles 1 year after surgery
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