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Phase II Trial of Immunonutrition in Hepatectomy

ConditionsHepatocellular CarcinomaASA I-III Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTata Memorial Centre

About this trial

A randomised open labelled study to evalaute the impact of immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with liver tumors planned for major hepatectomies (defined as resection of >/= 3 liver segments)

Age above 18 years

ASA class I-III

Disqualifiers

Preoperative severe renal failure (estimated glomerular filtration rate < 30 ml/min)

History of hypersensitivity to arginine, omega-3 fatty acids, or nucleotide 3. Inability to take oral nutrition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunonutrition

    Dietary supplement

    In addition to their usual intake, patients in the intervention arm will be prescribed for each of the 7 consecutive days preceding surgery 6-9 scoops PENTASURE Immunomax® powder (120-180g per day)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Standard ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Preoperative immunonutrition improves prognostic nutritional index (PNI)

improvement in prognostic nutritional index after maor hepatectomies calculated with the help of Prognostic Nutritional Index (PNI) = \[(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)\].

Time frame
90 days

Secondary outcomes

1

Incidence of postoperative complications

number of complications in both arm major with Clavien-Dindo (CD) classification for adverse events 2. Incidence of post-hepatectomies liver failure (PHLF) 3. Length of ICU stay 4. Length of hospital stay, 5. Incidence of 90 days mortality

Time frame
upto 3 months
2

Incidence of post-hepatectomies liver failure (PHLF)

nuber of patients undergoing hepatice failure in both study arm after the major hepatectomies define by ndicated by elevated total bilirubin (\\(\>22\\ \\mu \\text{mol/L}\\)) and increased INR (\\(\>1.2\\)) on or after the fifth postoperative day (POD 5), as per ISGLS criteria

Time frame
Perioperative upto day 5
3

Length of ICU stay

number of days participant spent in ICU after hepatectomy till discharge in both treatment group

Time frame
Perioperative upto day 30
4

Length of hospital stay,

number of days participant spent in hospital after hepatectomy till discharge in both treatment group

Time frame
Perioperative upto day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov
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