Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

NCT04607057 | Unknown Phase 4 DMC

• 1 other identifier: H-2005-159-1126
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Gastric Cancer; Gastrectomy; Malnutrition

Keywords

Gastric cancer; Postgastrectomy; Malnutrition; Supplemental; Parenteral nutrition

Outcome Measures

Primary Outcomes (2)

• Total amount of calorie provision during hospitalization

  kcal (kilocalorie)

  discharge day (POD#8; postoperative day 8)

• Body weight change for 2 months after surgery

  kg (kilogram)

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

Secondary Outcomes (20)

• Body weight and fat free mass changes

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

• Changes in blood test indicators : Hb

  through study completion, an average of 1 year

• Changes in blood test indicators : WBC

  through study completion, an average of 1 year

• Changes in blood test indicators : lymphocyte

  through study completion, an average of 1 year

• Changes in blood test indicators : TLC

  through study completion, an average of 1 year

Study Arms (2)

experimental group (Arm A)

EXPERIMENTAL

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

Drug: Parenteral Nutrition Solutions

control group (Arm B)

NO INTERVENTION

* 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)

Interventions

Parenteral Nutrition Solutions DRUG

* 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

experimental group (Arm A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Stomach Neoplasms; Malnutrition; Hyperphagia

Interventions

Parenteral Nutrition Solutions

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Hyuk-Joon Lee, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuk-Joon Lee, Professor

CONTACT

82-02-9092-3723; appe98@snu.ac.kr

Sa-Hong Kim, Fellow

CONTACT

82-10-7588-5477; kshsnuhgs@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 28, 2020
• Study Start: December 22, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)