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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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.
- overall survival from day of surgery [ Time Frame: 5 years postoperative ]overall survival at 5 years after esophagectomy
- postoperative weight loss [ Time Frame: 1 year after surgery ]weight loss will be calculated by using age- and gender corrected BMI percentiles
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
|Contact: Hans Van Veer, MD||+3216 341213||Hans.Vanveer@uzleuven.be|
|Contact: Johhny Moons, MScN||+3216 firstname.lastname@example.org|
|University hospital Leuven||Enrolling by invitation|
|Leuven, Vl-Brabant, Belgium, 3000|
|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|