- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
- National Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
Ingen indgriben: historical control group
Historical control group is that did not receiving
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
postoperative complication
Tidsramme: 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.)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
postoperative hospital stay
Tidsramme: 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
Tidsramme: preoperative, postoperative 14days
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preoperative, postoperative 14days
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preoperative, postoperative 14days
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postoperative cost( + nutritional support cost)
Tidsramme: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
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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.)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
immunologic change(CD4/CD8) after nutritional support
Tidsramme: preoperative, postoperative 14days
|
CD4/CD8, immunoglobulin G, M, A
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preoperative, postoperative 14days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: SangJae Park, National Cancer Center, Korea
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCCCTS-13-676
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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