E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Periampullary or pancreatic cancer |
Tumore pancreatico o periampollare |
|
E.1.1.1 | Medical condition in easily understood language |
Periampullary or pancreatic cancer |
Tumore pancreatico o periampollare |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033644 |
E.1.2 | Term | Pancreaticoduodenectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061902 |
E.1.2 | Term | Pancreatic neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Complication burden as measured by the Comprehensive Complication Index (CCI) (20) within 30 days after hospital discharge. |
Riduzione del peso delle complicanze postoperatorie misurato con il Comprehensive Complication Index (CCI) del 30% |
|
E.2.2 | Secondary objectives of the trial |
- 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 |
- Calorie giornaliere fornite dalla nutrizione artificiale PN - Tasso di utilizzo della PN (gruppo di controllo) - Il tasso e la gravità delle complicanze a 30 giorni dalla dimissione - Tasso di infezioni postoperatorie (classificazione CDC) - Il tasso e la gravità della fistola pancreatica - Tasso e gravità del ritardato svuotamento gastrico - Tasso e gravità di sanguinamenti - Durata della degenza postoperatoria - Il tasso e la durata dei ricoveri in terapia intensiva - Il tasso di iperglicemia (glicemia> 180 mg / dL) - Necessità di terapia con insulina (bolo sottocutaneo o infusione continua) - Variazione livelli plasmatici di prealbumina (basale, giorno 1 post-operatorio e giorno 6 post-operatorio) - Uso della morfina - Peso corporeo a 30 e 90 giorni - Tasso di riospedalizzazione - Mortalità a 90 giorni |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patients (age = 18 and < 90 years of age) candidate to elective pancreatoduodenectomy for any periampullary or pancreatic cancer. - Patients must be willing to participate in the study and able to provide written informed consent form prior to any study activity. - Normal renal function, normal blood electrolytes (sodium, potassium, chlorite, magnesium, calcium and phosphorus) and normal coagulation tests (PT, PTT). |
- Pazienti adulti (età = 18 e <90 anni di età) candidati alla pancreatoduodenectomia elettiva per qualsiasi tumore periampollare o pancreatico. - I pazienti devono essere disposti a partecipare allo studio e in grado di fornire un modulo di consenso informato scritto prima di qualsiasi attività di studio. - Funzionalità renale normale, elettroliti ematici normali (sodio, potassio, clorito, magnesio, calcio e fosforo) e test di coagulazione normali (PT, PTT). |
|
E.4 | Principal 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 |
- Classificazione dello stato fisico dell'American Society of Anaesthesiologists (ASA)> 3 - Perdita di peso> 15% rispetto al peso normale negli ultimi 6 mesi (malnutrizione severa in base ai criteri GLIM) - Ascite - Qualsiasi reazione di ipersensibilità comprovata ai componenti della PN - Trattamento in corso con fenobarbital, fenitoina, primidone, levodopa - Chirurgia palliativa - Posizionamento di un sondino nasale-enterico o digiunostomico |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Complication burden as measured by the Comprehensive Complication Index (CCI) (20) within 30 days after hospital discharge. |
Riduzione del peso delle complicanze postoperatorie misurato con il Comprehensive Complication Index (CCI) del 30% |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after hospital discharge. |
30 giorni dalla dimissione |
|
E.5.2 | 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 |
- Calorie giornaliere fornite dalla nutrizione artificiale PN - Tasso di utilizzo della PN (gruppo di controllo) - Il tasso e la gravità delle complicanze a 30 giorni dalla dimissione - Tasso di infezioni postoperatorie (classificazione CDC) - Il tasso e la gravità della fistola pancreatica - Tasso e gravità del ritardato svuotamento gastrico - Tasso e gravità di sanguinamenti - Durata della degenza postoperatoria - Il tasso e la durata dei ricoveri in terapia intensiva - Il tasso di iperglicemia (glicemia> 180 mg / dL) - Necessità di terapia con insulina (bolo sottocutaneo o infusione continua) - Variazione livelli plasmatici di prealbumina (basale, giorno 1 post-operatorio e giorno 6 post-operatorio) - Uso della morfina - Peso corporeo a 30 e 90 giorni - Tasso di riospedalizzazione - Mortalità a 90 giorni |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 90 days after hospital discharge |
Fino a 90 giorni dopo la dimissione ospedaliera |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
nessun trattamento |
no treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |