Design of the EFECTS Trial
Not Applicable
Withdrawn
- Conditions
- Esophageal Cancer
- Interventions
- Other: Enteral feeding
- Registration Number
- NCT02017366
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enteral feeding 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.
- Primary Outcome Measures
Name Time Method overall survival from day of surgery 5 years postoperative overall survival at 5 years after esophagectomy
- Secondary Outcome Measures
Name Time Method postoperative weight loss 1 year after surgery weight loss will be calculated by using age- and gender corrected BMI percentiles
Trial Locations
- Locations (1)
University hospital Leuven
🇧🇪Leuven, Vl-Brabant, Belgium