NCT07584577

Brief Summary

Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Nov 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

29 days

First QC Date

September 19, 2025

Last Update Submit

May 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative complications according to the Clavien classification

    Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.

    Day 30

Study Arms (2)

Control group

patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.

Case group

patients who received enteral or parenteral nutrition during neoadjuvant treatment.

Dietary Supplement: Enteral or parenteral nutrition

Interventions

Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.

Case group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy. The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.

You may qualify if:

  • Patient undergoing surgery for esophageal cancer
  • Malnourished patient at the time of management
  • Receiving neoadjuvant treatment

You may not qualify if:

  • Patient not malnourished at the time of management
  • Patient who did not receive neoadjuvant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopîtal du Haut Lévêque

Pessac, 33600, France

RECRUITING

Related Publications (3)

  • Mariette C, De Botton ML, Piessen G. Surgery in esophageal and gastric cancer patients: what is the role for nutrition support in your daily practice? Ann Surg Oncol. 2012 Jul;19(7):2128-34. doi: 10.1245/s10434-012-2225-6. Epub 2012 Feb 10.

    PMID: 22322948BACKGROUND
  • Deftereos I, Kiss N, Isenring E, Carter VM, Yeung JM. A systematic review of the effect of preoperative nutrition support on nutritional status and treatment outcomes in upper gastrointestinal cancer resection. Eur J Surg Oncol. 2020 Aug;46(8):1423-1434. doi: 10.1016/j.ejso.2020.04.008. Epub 2020 Apr 18.

    PMID: 32336624BACKGROUND
  • Deftereos I, Yeung JM, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Preoperative Nutrition Intervention in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 15;13(9):3205. doi: 10.3390/nu13093205.

    PMID: 34579082BACKGROUND

MeSH Terms

Conditions

Esophageal NeoplasmsMalnutrition

Interventions

Parenteral 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

  • Caroline GRONNIER, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2025

First Posted

May 13, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data access via extraction from the national FREGAT database.

Shared Documents
STUDY PROTOCOL, SAP

Locations