Clinical trial · Interventional
Design of the EFECTS Trial
Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enteral feeding | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
- type
- ACTIVE_COMPARATOR
- label
- Enteral feeding
- description
- 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.
- interventionNames
- Other: Enteral feeding
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available