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

NCT07584577 — Recruiting, 670 participants, University Hospital, Bordeaux

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RegistryNCT07584577, acronym FREJENO
StatusRecruiting
Study typeObservational
Enrollment670 (Estimated)
SponsorUniversity Hospital, Bordeaux (Other); collaborators: French Eso-Gastric Tumors Working Group
ConditionsEsophageal Cancer, Surgery Indication, Malnourished, Neoadjuvant Treatment
InterventionsEnteral or parenteral nutrition (Dietary supplement)
Datesstart 2026-11-01 (estimated), primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2026-05-13, last updated 2026-05-13
Locations1 site in France

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-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Control grouppatients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
Case groupDietary Supplement: Enteral or parenteral nutritionpatients who received enteral or parenteral nutrition during neoadjuvant treatment.
  • Enteral or parenteral nutrition (Dietary supplement): Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.

+Outcome measures

Primary outcomes

  • Rate of postoperative complications according to the Clavien classification [Day 30]: Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hopîtal du Haut LévêquePessacFranceRecruiting

+Publications

  • 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 22322948
  • 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 32336624
  • 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 34579082

+Investigators

  • Caroline GRONNIER, MD, PhD, Principal investigator, University Hospital, Bordeaux

My Notes