The effect of postoperative supplemental parenteral nutrition (SPN) in gastric cancer patients who underwent gastrectomy: A multicenter prospective randomized controlled trial

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0005570
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 December 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total amount of calorie provision during hospitalization;Body weight change for 2 months after surgery

Secondary Outcome Measures

Name	Time	Method
Body weight and fat free mass changes;Changes in blood test indicators;Changes in serum cytokines;Probability for chemotherapy;Infection rate;Total days of hospitalization;Mortality rate