Design of the EFECTS Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2022-04-30

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.

Detailed Description

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Conditions

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Esophageal Cancer

Keywords

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Surgery Malnutrition Nutrition, Enteral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Enteral feeding

Intervention Type OTHER

Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

Interventions

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Enteral feeding

Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hans Van Veer, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR