Design of the EFECTS Trial

Not Applicable

Withdrawn

• Conditions: Esophageal Cancer

• Registration Number: NCT02017366
• Lead Sponsor: University Hospital, Gasthuisberg

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Study Start: 2018-10
• Primary Completion: 2021-10
• Study Completion: 2022-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall survival from day of surgery	5 years postoperative	overall survival at 5 years after esophagectomy

Secondary Outcome Measures

Name	Time	Method
postoperative weight loss	1 year after surgery	weight loss will be calculated by using age- and gender corrected BMI percentiles

Trial Locations

Locations (1)

University hospital Leuven; 🇧🇪 Leuven, Vl-Brabant, Belgium