Design of the EFECTS Trial

University Hospital, Gasthuisberg

Status: Withdrawn

Conditions: Esophageal Cancer

Treatments: Other: Enteral feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT02017366

EFECTS

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control

No Intervention group

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.

Enteral feeding

Active Comparator group

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.

Treatment:

Other: Enteral feeding