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Design of the EFECTS Trial (EFECTS)

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ClinicalTrials.gov Identifier: NCT02017366
Recruitment Status : Unknown
Verified December 2013 by Johnny Moons, University Hospital, Gasthuisberg.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Johnny Moons, 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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: Enteral feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
Study Start Date : February 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. overall survival from day of surgery [ Time Frame: 5 years postoperative ]
    overall survival at 5 years after esophagectomy


Secondary Outcome Measures :
  1. postoperative weight loss [ Time Frame: 1 year after surgery ]
    weight loss will be calculated by using age- and gender corrected BMI percentiles



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017366


Contacts
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Contact: Hans Van Veer, MD +3216 341213 Hans.Vanveer@uzleuven.be
Contact: Johhny Moons, MScN +3216 346825 johnny.moons@uzleuven.be

Locations
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Belgium
University hospital Leuven Enrolling by invitation
Leuven, Vl-Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
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Principal Investigator: Hans Van Veer, MD Universitaire Ziekenhuizen Leuven
Study Chair: Philippe Nafteux, MD Universitaire Ziekenhuizen Leuven
Study Chair: Willy Coosemans, MD, PhD Universitaire Ziekenhuizen Leuven
Study Chair: Johnny Moons, MScN Universitaire Ziekenhuizen Leuven
Study Director: Paul De Leyn, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Johnny Moons, MScN, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT02017366     History of Changes
Other Study ID Numbers: EFECTS
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013

Keywords provided by Johnny Moons, University Hospital, Gasthuisberg:
Surgery
Malnutrition
Nutrition, Enteral

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases