Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient (SUPPORT)
Gastric Cancer, Gastrectomy, Malnutrition
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Postgastrectomy, Malnutrition, Supplemental, Parenteral nutrition
Eligibility Criteria
Inclusion Criteria:
- Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy)
A Malnourished patient who meets one or more of the following:
- BMI ≤ 20.5 kg/m2: BMI will be measured 1 day before surgery
- Rapid weight loss (decreased by more than 5% in 2 months)
- Patients over 18 years of age
- Patients who are expected to receive PN for more than five days after surgery
- Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone.
Exclusion Criteria:
- In case that the patients have already provided parenteral nutrition prior to the consent of the study (oral diet prior to consent has nothing to do with study)
- In case that the patients need tube feeding
- Patients who are contraindicated to parenteral nutrition: heart failure (if the patient has current symptoms or receiving heart failure treatment, if ejection fraction(EF) was less than 40% in preoperative echocardiogram), Child-Pugh score C, renal failure (patient with 50% increased creatinine more than upper normal limit, patients currently undergoing renal replacement therapy), and pulmonary edema (appropriate chest X-ray signs for pulmonary edema), and the patient who suffered from allergie reaction to parenteral nutrition solutions.
- Patients who are not easily able to obtain venous pathways or are vulnerable to side effects due to venous pathways (e.g. increased infection risk due to immunosupressant status)
- Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive)
- Other patients whom the investigator has determined to be inappropriate to participate in this study
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
experimental group (Arm A)
control group (Arm B)
Preparation of parenteral nutrition (PN): Among winuf(1820cc for central vein, 1,450cc for peripheral vein), smofkabaven(986cc for central vein, 1206cc for peripheral vein), and nutriplex(1875cc for central vein, 1,250cc for peripheral vein) Amount of PN: Total energy expenditure (TEE) of the patients will be calculated with Harris-Benedict Equation, activity factor, and stress factor. The amount of calorie from oral intake will be subtracted from TEE then the remainder will be provided through PN. Route of PN Injection: PICC (percutaneously-inserted central catheter) will be secured for PN for the central vein. PN for the peripheral vein will be injected directly through peripheral superficial vein. Day0 : fasting(NPO) + crystalloid fluid POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid POD#2 : Semifluid diet (SFD) + crystalloid fluid POD#3 : Semifluid diet (SFD) + PN POD#4-7: Soft blended diet (SBD) + PN
Day0 : fasting(NPO) + crystalloid fluid POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid POD#2 : Semifluid diet (SFD) + dextrose 5% water POD#3 : Semifluid diet (SFD) + dextrose 5% water POD#4-7: Soft blended diet (SBD)