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Design of the EFECTS Trial

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02017366
Acronym
EFECTS
Enrollment
0
Registered
2013-12-20
Start date
2018-10-31
Completion date
2022-04-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Surgery, Malnutrition, Nutrition, Enteral

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.

Interventions

OTHEREnteral feeding

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

Sponsors

University Hospital, Gasthuisberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall survival from day of surgery5 years postoperativeoverall survival at 5 years after esophagectomy

Secondary

MeasureTime frameDescription
postoperative weight loss1 year after surgeryweight loss will be calculated by using age- and gender corrected BMI percentiles

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026