Periampullary or pancreatic cancer MedDRA version: 21.1 Level: PT Classification code 10033644 Term: Pancreaticoduodenectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10061902 Term: Pancreatic neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Olimel N4E
Product Name: Olimel N4E
Product Code: [Olimel N4E]
Pharmaceutical Form: Solution for injection
Current Sponsor code: Olimel N4E
Concentration unit: U unit(s)
Concentration type
Sponsors
UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (age = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - American Society of Anaesthesiologists (ASA) physical status classification > 3 - Weight loss > 15% with respect to usual weight in the last 6 months (severe malnutrition according to the new GLIM criteria) - Ascites - Any proven hypersensitivity reaction to PN components - Ongoing treatment with fenobarbital, fenitoine, primidone, levodopa - Palliative surgery - Placement of a naso-enteric or jejunostomy feeding tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Complication burden as measured by the Comprehensive Complication Index (CCI) (20) within 30 days after hospital discharge.;Secondary Objective: - Daily calorie delivered by PN - Rate of unplanned PN (control group) - The rate and severity* of complications at 30 days after discharge - Rate of surgical site infections (CDC classification) - The rate and severity of postoperative pancreatic fistula (POPF) - Rate and severity of DGE - Rate and severity of haemorrhage - Length of stay (LOS) based on predefined criteria, and actual LOS - The rate of reoperation - The rate and duration of intensive care treatment - The rate of hyperglycaemia (blood glucose > 180 mg/dL) - Use of insulin (subcutaneous bolus or continuous infusion) - Variation plasma prealbumin levels (baseline, postoperative day 1 (POD1) and postoperative day 6 (POD 6)) - Use of morphine - Body weight at 30 and 90 days - Readmission rate - 90-day mortality;Primary end point(s): Complication burden as measured by the Comprehensive Complication Index (CCI) (20) within 30 days after hospital discharge.;Timepoint(s) of evaluation of this end point: 30 days after hospital discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Daily calorie delivered by PN - Rate of unplanned PN (control group) - The rate and severity* of complications at 30 days after discharge - Rate of surgical site infections (CDC classification) - The rate and severity of postoperative pancreatic fistula (POPF) - Rate and severity of DGE - Rate and severity of haemorrhage - Length of stay (LOS) based on predefined criteria, and actual LOS - The rate of reoperation - The rate and duration of intensive care treatment - The rate of hyperglycaemia (blood glucose > 180 mg/dL) - Use of insulin (subcutaneous bolus or continuous infusion) - Variation plasma prealbumin levels (baseline, postoperative day 1 (POD1) and postoperative day 6 (POD 6)) - Use of morphine - Body weight at 30 and 90 days - Readmission rate - 90-day mortality;Timepoint(s) of evaluation of this end point: Up to 90 days after hospital discharge | — |
Countries
Italy
Contacts
Public ContactUfficio BiCRO (Bicocca Clinical Res
Università Milano-Bicocca
Outcome results
None listed