Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial

Janine Krüger, Peter J Meffert, Lena J Vogt, Simone Gärtner, Antje Steveling, Matthias Kraft, Julia Mayerle, Markus M Lerch, Ali A Aghdassi, Janine Krüger, Peter J Meffert, Lena J Vogt, Simone Gärtner, Antje Steveling, Matthias Kraft, Julia Mayerle, Markus M Lerch, Ali A Aghdassi

Abstract

Purpose: Patients with biliopancreatic tumors frequently suffer from weight loss and cachexia. The in-hospital work-up to differentiate between benign and malignant biliopancreatic lesions requires repeated pre-interventional fasting periods that can aggravate this problem. We conducted a randomized intervention study to test whether routine in-hospital peripheral intravenous nutrition on fasting days (1000 ml/24 h, 700 kcal) has a beneficial effect on body weight and body composition.

Material and methods: 168 patients were screened and 100 enrolled in the trial, all undergoing in-hospital work-up for biliopancreatic mass lesions and randomized to either intravenous nutrition or control. Primary endpoint was weight loss at time of hospital discharge; secondary endpoints were parameters determined by bioelectric impedance analysis and quality of life recorded by the EORTC questionnaire.

Results: Within three months prior to hospital admission patients had a median self-reported loss of 4.0 kg (25*th: -10.0 kg and 75*th* percentile: 0.0kg) of body weight. On a multivariate analysis nutritional intervention increased body weight by 1.7 kg (95% CI: 0.204; 3.210, p = 0.027), particularly in patients with malignant lesions (2.7 kg (95% CI: 0.71; 4.76, p < 0.01).

Conclusions: In a hospital setting, patients with suspected biliopancreatic mass lesions stabilized their body weight when receiving parenteral nutrition in fasting periods even when no total parenteral nutrition was required. Analysis showed that this effect was greatest in patients with malignant tumors. Further studies will be necessary to see whether patient outcome is affected as well.

Trial registration: ClinicalTrials.gov NCT02670265.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. CONSORT diagram of the trial.
Fig 1. CONSORT diagram of the trial.
Fig 2. Mean weight changes by intervention…
Fig 2. Mean weight changes by intervention and tumor status.
Shown are expected marginal means at means of the covariates (sex, age, length of hospital stay, electrolyte solution, weight at admission, malignant tumor, oral supplements and proportion of fasting time). However, the difference between tumor group (total n = 39; control = 19, intervention n = 20) and non-tumor group (total n = 40; control n = 21; intervention = 19) in body-weight change was not statistically significant (p = 0.058).
Fig 3. Mean changes in percent from…
Fig 3. Mean changes in percent from means at admission for intervention and control group in men and women.
Shown are expected marginal means at means of the covariates (sex, age, length of hospital stay, electrolyte solution, weight at admission, malignant tumor, oral supplements and proportion of fasting time). Asterisks refer to the statistical significance of the difference between intervention and control group, n = 79. * p

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