Design of the EFECTS Trial (EFECTS)

November 29, 2023 updated by: Hans Van Veer, MD, University Hospital, Gasthuisberg

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vl-Brabant
      • Leuven, Vl-Brabant, Belgium, 3000
        • University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks.
Active Comparator: Enteral feeding
Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration.
Other: Enteral feeding
Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival from day of surgery
Time Frame: 5 years postoperative
overall survival at 5 years after esophagectomy
5 years postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative weight loss
Time Frame: 1 year after surgery
weight loss will be calculated by using age- and gender corrected BMI percentiles
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Hans Van Veer, MD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Philippe Nafteux, MD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Willy Coosemans, MD, PhD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Johnny Moons, MScN, Universitaire Ziekenhuizen KU Leuven
  • Study Director: Paul De Leyn, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2018

Primary Completion (Estimated)

October 1, 2021

Study Completion (Estimated)

April 1, 2022

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimated)

December 20, 2013

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFECTS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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