Design of the EFECTS Trial

Study Overview
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Brief Summary
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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.

Official Title
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Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: Enteral feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival from day of surgery | overall survival at 5 years after esophagectomy | 5 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative weight loss | weight loss will be calculated by using age- and gender corrected BMI percentiles | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Malnutrition, Nutrition, Enteral