NCT02017366

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
4.8 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

December 16, 2013

Last Update Submit

November 29, 2023

Conditions

Esophageal Cancer

Keywords

SurgeryMalnutritionNutrition, Enteral

Outcome Measures

Primary Outcomes (1)

  • overall survival from day of surgery

    overall survival at 5 years after esophagectomy

    5 years postoperative

Secondary Outcomes (1)

  • postoperative weight loss

    1 year after surgery

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Enteral feedingOTHER

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

Enteral feeding

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • transhiatal
  • pt in definitive CRT or rescue resection following definitive CRT
  • palliative treatment
  • tumours in cervical esophagus
  • pharyngeal cancer with gastric pull-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Leuven

Leuven, Vl-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Esophageal NeoplasmsMalnutrition

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Hans Van Veer, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Philippe Nafteux, MD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

  • Willy Coosemans, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

  • Johnny Moons, MScN

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

  • Paul De Leyn, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

October 1, 2018

Primary Completion

October 1, 2021

Study Completion

April 1, 2022

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations

BE(1)