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WithdrawnNCT02017366EFECTSUpdated Dec 6, 2023

Design of the EFECTS Trial

An interventional study of Enteral feeding in Esophageal Cancer, sponsored by University Hospital, Gasthuisberg. Withdrawn at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by University Hospital, Gasthuisberg · Not applicable, Interventional, and Basic science

Why this study was withdrawn
adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review

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Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 41 studies in Esophageal Neoplasms with a site in Belgium — 17 open to participants now, 22 under way, 5 of them phase 3. Esophageal Neoplasms · Belgium.

Enrollment
32nd of 32
0 · median 198
Started
2018
with 5 others
No phase
11 of 41
7 open now
Registered
11th of 41
by date
Lead sponsor
5 of 41
University Hospital, Gasthuisberg

Among the 41 studies in Esophageal Neoplasms with a site in Belgium, this one is the 32nd largest by enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2018, is one of 11 with no phase, and was the 11th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

Browse Esophageal Neoplasms studies →

Open to participants now

17 of the 41 studies in Esophageal Neoplasms with a site in Belgium are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Esophageal Cancer

Keywords

  • Surgery
  • Malnutrition
  • Nutrition, Enteral
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • OtherEnteral feeding

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

06

What researchers measure

Primary outcomes

  1. overall survival from day of surgery

    overall survival at 5 years after esophagectomy

    Time frame: 5 years postoperative

Secondary outcomes

  1. postoperative weight loss

    weight loss will be calculated by using age- and gender corrected BMI percentiles

    Time frame: 1 year after surgery

07

Study locations

1 site
  • University hospital Leuven
    Leuven, Vl-Brabant 3000, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2018; primary completion for Oct 2021, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2013
First posted
Dec 20, 2013
StartEst.
Oct 2018
Primary completionEst.
Oct 2021
CompletionEst.
Apr 2022
Last update
Dec 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02017366
Lead sponsor
University Hospital, Gasthuisberg
Responsible party
Hans Van Veer, MD (MD, University Hospital, Gasthuisberg) — Principal investigator
First posted
Dec 20, 2013
Start date
Oct 2018 (estimated)
Primary completion
Oct 2021 (estimated)
Completion
Apr 2022 (estimated)
Last update
Dec 6, 2023

Study contacts

Hans Van Veer, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Philippe Nafteux, MD
study chair · Universitaire Ziekenhuizen KU Leuven
Willy Coosemans, MD, PhD
study chair · Universitaire Ziekenhuizen KU Leuven
Johnny Moons, MScN
study chair · Universitaire Ziekenhuizen KU Leuven
Paul De Leyn, MD, PhD
study director · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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