Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

Seoul National University Hospital224 enrolled

Overview

* If a patient undergoes gastrectomy, which is a kind of major abdominal operation, he/she loses more than 5% of his/her body weight in 2 months after surgery. This point is one of the criteria of 'risk of malnutrition' according to Nutrition Risk Screening (NRS 2002) and the patient who corresponds to this criterion needs nutritional support. * According to Nutrition Risk Screening (NRS 2002), moderate malnutrition is defined as the state that the patient orally intakes 25\~50% of recommended requirements; severe malnutrition is less than 25%. * Meanwhile, when oral nutrition support was provided to patients after gastric cancer surgery, the patients' average daily intake during the first three months was about a half of the recommended requirements. * Putting together the facts i) that the patient underwent major abdominal operation, ii) that the weight loss rate exceeded 5% for two months, iii) that the average daily intake of patients during the first three months was about half of the recommended amount, the patients are eligible to be classified as a group who require nutritional support according to NRS 2002. Therefore, it is intended to verify the efficacy and safety of supplemental parenteral nutrition by comparing Arm A, who are provided oral intake with supplemental parenteral nutrition, Arm B, who are provided oral intake only after curative gastric cancer surgery.

With at least 5 days of supplemental parenteral nutrition, we expect minimized body weight loss, favorable blood test result, eligibility for chemotherapy compliance, increased quality of life (QoL), decreased infection rate, decreased hospital stay, and decreased mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy) 2. 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) 3. Patients over 18 years of age 4. Patients who are expected to receive PN for more than five days after surgery 5. Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone. Exclusion Criteria: 1. 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) 2. In case that the patients need tube feeding 3. 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. 4. 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) 5. Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive) 6. Other patients whom the investigator has determined to be inappropriate to participate in this study

Outcomes

Primary Outcomes

Total amount of calorie provision during hospitalization

kcal (kilocalorie)

Time frame: discharge day (POD#8; postoperative day 8)

Body weight change for 2 months after surgery

kg (kilogram)

Time frame: Outpatient (visit 2: 2 months ± 14 days after surgery)

Secondary Outcomes

Body weight and fat free mass changes

kg (kilogram)

Time frame: Body weight: through study completion / Fat free mass: through study completion, an average of 1 year

Changes in blood test indicators : Hb

Complete blood count : Hb (hemoglobin) : g/dl

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : WBC

Complete blood count : WBC (white blood cell) : cells/mm3

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : lymphocyte

Complete blood count : lymphocyte (%)

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : TLC

Complete blood count : TLC (total lymphocyte count) : cells/mm3

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : total cholesterol

Blood chemistry : total cholesterol (mg/dl)

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : total protein

Blood chemistry : total protein (g/dl)

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : albumin

Blood chemistry : albumin (g/dl)

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : AST

Blood chemistry : AST (aspartate aminotransferase) : IU/L

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : ALT

Blood chemistry : ALT (alanine aminotransferase) : IU/L

Time frame: through study completion, an average of 1 year

Changes in blood test indicators : CRP

Blood chemistry : CRP (C-reactive protein) : mg/dl

Time frame: through study completion, an average of 1 year

Changes in serum cytokines

ng/ml

Time frame: approximately up to 2 weeks

Probability for chemotherapy : ECOG performance status

ECOG(Eastern Cooperative Oncology Group) performance status: 0\~5 (higher scores mean a worse outcome) 0 : Fully active, able to carry on all pre-disease performance without restriction 5 : Death

Time frame: through study completion, an average of 1 year

Probability for chemotherapy : ASA score

ASA(American Society of Anaesthesiologists) score : 1\~6 (higher scores mean a worse outcome) 1 : A normal healthy patient 6 : A declared brain-dead patient whose organs are being removed for donor purposes

Time frame: through study completion, an average of 1 year

QoL : EORTC QLQ-C30

EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) : EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001).

Time frame: through study completion, an average of 1 year

QoL : EORTC QLQ-STO22

EORTC QLQ-STO22 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach 22) : Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer (J.M Blazeby el al. 2004).

Time frame: through study completion, an average of 1 year

QoL : SF-36

SF-36 (36-Item Short Form Health Survey) : 0\~100 (higher scores mean a worse outcome)

Time frame: through study completion, an average of 1 year

Infection rate

proportion

Time frame: During the hospitalization (approximately up to 2 weeks)

Total days of hospitalization

day

Time frame: at Discharge Day (POD#8; postoperative day 8)

Mortality rate

proportion

Time frame: through study completion, an average of 1 year

Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts