Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial.

BACKGROUND: Malnutrition is an independent risk factor of postoperative morbidity and mortality and it's observed in 20 to 50% of surgical patients. Preoperative interventions to optimize the nutritional status, reduce postoperative complications and enteral nutrition has proven to be superior to the parenteral one. Moreover, regardless of the nutritional status of the patient, surgery impairs the immunological response, thus increasing the risk of postoperative sepsis. Immunonutrition has been developed to improve the immunometabolic host response in perioperative period and it has been proven to reduce significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. We hypothesize that a preoperative oral immunonutrition (ORAL IMPACT®) can reduce postoperative morbidity in liver resection for cancer. METHODS/DESIGN: Prospective multicenter randomized placebo-controlled double-blind phase IV trial with two parallel treatment groups receiving either study product (ORAL IMPACT®) or control supplement (isocaloric isonitrogenous supplement--IMPACT CONTROL®) for 7 days before liver resection for cancer. A total of 400 patients will be enrolled. Patients will be stratified according to the type of hepatectomy, the presence of chronic liver disease and the investigator center. The main end-point is to evaluate in intention-to-treat analysis the overall 30-day morbidity. Secondary end-points are to assess the 30-day infectious and non-infectious morbidity, length of antibiotic treatment and hospital stay, modifications on total food intake, compliance to treatment, side-effects of immunonutrition, impact on liver regeneration and sarcopenia, and to perform a medico-economic analysis. DISCUSSION: The overall morbidity rate after liver resection is 22% to 42%. Infectious post-operative complications (12% to 23%) increase the length of hospital stay and costs and are responsible for a quarter of 30-day mortality. Various methods have been advocated to decrease the rate of postoperative complications but there is no evidence to support or refute the use of any treatment and further trials are required. The effects of preoperative oral immunonutrition in non-cirrhotic patients undergoing liver resection for cancer are unknown. The present trial is designed to evaluate whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for cancer. TRIAL REGISTRATION: Clinicaltrial.gov: NCT02041871.

HEPACOM: multicenter, observational prospective study of outcome and monitoring of HCV positive antiviral-naïve patients managed in the French health care system.

OBJECTIVE: To study management practices in the French health care system for antiviral-naïve patients with chronic hepatitis C virus (HCV) infection. METHODS AND PATIENTS: Two groups of general practitioners, group I (special training and experience in drug addiction) and group II (other general practitioners) enrolled untreated HCV positive patients and noted management practices for a 12-month period. RESULTS: Among 4660 enrolled patients, 2038 enrolled by 462 general practitioners in group I and 1756 enrolled by 588 general practitioners in group II were retained for analysis. These patients were adults, aged 42+/-14 years, who were naïve to antiviral treatment. The male/female ratio was 1: 7. Ten percent were coinfected with HIV, 12% had excessive alcohol intake, and 61% were current drug users, 75% of whom (45% of the total population) were taking replacement therapy. Minimal hepatic lesions (stageor=F2). At the end of the monitoring period, 64% of the patients had been referred to a specialist. Antiviral treatment had been started in 20%, i.e. 32% of the patients who consulted a specialist. Occupational activity (P<0.0001), young age (P=0.007), more recent diagnosis (P<0.0001), lack of HIV co-infection (P=0.015), male gender (P=0.006), lack of replacement treatment (P=0.006), previous liver histology with METAVIR A and F>or=2 (P<0.0001) and enrollment by a group I general practitioner (P<0.007) were the independent predictive factors of initiation of antiviral treatment. CONCLUSION: Only one-third of patients with access to the French health care system started antiviral treatment and some categories of patients, including women, patients co-infected with HIV and patients on replacement therapy, were less likely to be treated than others. The recommendations of the French Consensus Conference, held in the middle of the study period (2002), might have been implemented (probably followed) by a minority of general practitioners.