Supplemental parenteral nutrition within an enhanced recovery program for open pancreatoduodenectomy for cancer: a pragmatic, multicenter, randomized controlled trial
Notice bibliographique
Résumé
Background: The role of supplemental parenteral nutrition (SPN) following pancreatoduodenectomy (PD) in the context of an enhanced recovery program is unexplored. This study aimed to determine whether SPN is superior to early oral feeding alone in reducing postoperative complications. Methods: This pragmatic, multicenter, randomized controlled, trial, across five centers in Italy, enrolled patients aged 18-89 years undergoing open PD for cancer. We excluded patients with an American Society of Anaesthesiology physical status >3 and a preoperative body weight loss of ≥15%. Patients were randomly assigned (1:1) postoperatively to either SPN from day 1 to 5 or no-SPN. All patients were free to begin oral feeding after the operation as desired in the context of a full enhanced recovery after surgery (ERAS) program. The primary outcome was morbidity burden, measured using the comprehensive complication index (CCI). Secondary outcomes included the overall rate of morbidity. Outcomes were assessed up to 90 days postoperatively. Overall, 120 patients per group were required to achieve 80% power and detect at least 30% reduction in the CCI in the SPN group, which was expected to be 23 (median) (interquartile range 21-31). The expected complication rate was 60%, and the type I error rate was set at 5%. Registration at ClinicalTrials.gov (#NCT04438447). Findings: From June 1, 2022, to December 20, 2023, 405 patients were screened for eligibility and 254 patients were randomly allocated to control (no-SPN; n = 129) or treatment (SPN; n = 125) group. All patients were included in the primary and secondary outcome analysis according to the intent-to-treat principle. The median CCI was 20.9 in both arms (median difference 0 [95% CI: -1.07 to 1.7]). The proportion of patients with at least one complication (CCI >0) was similar in both groups [(29.6% vs 29.2%; risk difference 0.4 (95% CI -11.1 to 7.0)]. The overall 90-day morbidity was 67.4% and 63.2% in the no-SPN arm and SPN arm groups, respectively [risk difference -4.2 (95% CI -16.7 to 8.2)]. In high nutritional risk patients (nutritional risk score ≥3), SPN was not protective against the primary outcome when compared with low-risk patients [OR 1.16 (95% CI 0.71-1.91)]. Interpretation: In an ERAS program emphasizing early postoperative oral feeding, SPN does not affect outcome measures, even in patients at high nutritional risk. However, these results do not apply to severely malnourished patients or with critical comorbidities. Funding: The Italian Society for Artificial Nutrition and Metabolism (SINPE) and Baxter Italia S.p.A (Rome, Italy).
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,005 | 0,008 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,005 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».