| Registry | NCT07584577, acronym FREJENO |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 670 (Estimated) |
| Sponsor | University Hospital, Bordeaux (Other); collaborators: French Eso-Gastric Tumors Working Group |
| Conditions | Esophageal Cancer, Surgery Indication, Malnourished, Neoadjuvant Treatment |
| Interventions | Enteral or parenteral nutrition (Dietary supplement) |
| Dates | start 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 |
| Locations | 1 site in France |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control group | patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. | ||
| Case group | Dietary Supplement: Enteral or parenteral nutrition | patients who received enteral or parenteral nutrition during neoadjuvant treatment. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hopîtal du Haut Lévêque | Pessac | France | Recruiting |