- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02626195
Preoperative Nutritional Support in Malnutritional Cancer Patients
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.
The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).
For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
- Calories: 30-35Kg, via enteral or parenteral
- Protein: 1.2-1.5g/Kg
- Lipid : 1-1.5g/Kg
- Mineral and vitamins supply
- Blood glucose control
- Daily monitoring by dietician and specialized nurse
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republik von, 410-769
- National Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
Patients diagnosed with malnutrition (at least more than one)
- PG-SGA B or C
- Weight loss >10% within 6 month
- BMI <18.5
- Serum Albumin <3.0
- Age less than 80 years old over 20 years old
- Performance status (ECOG scale): 0-1
Adequate organ functions
- Hb ≥7.0 g/dl
- ANC ≥1,500/mm3
- PLT ≥80,000/mm3
- Liver function: AST/ALT ≤5×upper limit of normal
- Creatinine ≤2.0 ULN
Exclusion Criteria:
- Biopsy, drainage tube insertion, and other minor surgery
- palliative surgery
Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Pregnancy
- Any patients judged by the investigator to be unfit to participate in the study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: nutritional support program apply
Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.
|
Nutritional support program is briefly described below. Interval: 5-10 days Contents: admission is required
|
|
Kein Eingriff: historical control group
Historical control group is that did not receiving
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
postoperative complication
Zeitfenster: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
|
expected the duration of hospital stay of postoperation is 4~6 weeks.
|
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
postoperative hospital stay
Zeitfenster: expected the duration of hospital stay of postoperation is 4~6 weeks.
|
expected the duration of hospital stay of postoperation is 4~6 weeks.
|
expected the duration of hospital stay of postoperation is 4~6 weeks.
|
|
quality of life
Zeitfenster: preoperative, postoperative 14days
|
preoperative, postoperative 14days
|
preoperative, postoperative 14days
|
|
postoperative cost( + nutritional support cost)
Zeitfenster: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
|
expected the duration of hospital stay of postoperation is 4~6 weeks.
|
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
immunologic change(CD4/CD8) after nutritional support
Zeitfenster: preoperative, postoperative 14days
|
CD4/CD8, immunoglobulin G, M, A
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preoperative, postoperative 14days
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: SangJae Park, National Cancer Center, Korea
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCCCTS-13-676
Plan für individuelle Teilnehmerdaten (IPD)
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