Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005570
Enrollment
224
Registered
2020-11-03
Start date
2020-10-30
Completion date
Unknown
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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(1875c

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Total amount of calorie provision during hospitalization;Body weight change for 2 months after surgery

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSa-Hong Kim

Seoul National University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026