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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 Withdrawn at 1 site in Belgium.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Why this study was withdrawn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
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Surgery
  • Malnutrition
  • Nutrition, Enteral
03

Who can participate

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

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
04

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.

05

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

06

Study locations

1 site
  • University hospital Leuven
    Leuven, Vl-Brabant 3000, Belgium
07

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 ↗

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