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NCT Number: NCT07584577

Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopîtal du Haut Lévêque

Pessac, 33600, France

Location status: Recruiting

Location contact

Caroline GRONNIER

CONTACT

[email protected]

+ 33 5 57 65 60 05

Caroline GRONNIER, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.

However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.

An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.

In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Enteral or parenteral nutrition

Dietary Supplement

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

Primary outcomes

  1. Rate of postoperative complications according to the Clavien classification

    Time frame: Day 30

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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline GRONNIER, PhD, MD

CONTACT

[email protected]

+335-57-62-24-77

Valérie AURILLAC

CONTACT

[email protected]

+335-57-62-24-77

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • French Eso-Gastric Tumors Working Group

Registry information

Acronym: FREJENO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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