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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
|
|
| control group (Arm B) | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral Nutrition Solutions | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight and fat free mass changes | kg (kilogram) | Body weight: through study completion / Fat free mass: through study completion, an average of 1 year |
| Changes in blood test indicators : Hb |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Hyuk-Joon Lee, Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15494286 | Background | Scholmerich J. Postgastrectomy syndromes--diagnosis and treatment. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):917-33. doi: 10.1016/j.bpg.2004.08.003. | |
| 17404848 | Background | Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3. |
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Sharing the specific individual participant data sets is not mandatory.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D044342 | Malnutrition |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057947 | Parenteral Nutrition Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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|
Complete blood count : Hb (hemoglobin) : g/dl
| through study completion, an average of 1 year |
| Changes in blood test indicators : WBC | Complete blood count : WBC (white blood cell) : cells/mm3 | through study completion, an average of 1 year |
| Changes in blood test indicators : lymphocyte | Complete blood count : lymphocyte (%) | through study completion, an average of 1 year |
| Changes in blood test indicators : TLC | Complete blood count : TLC (total lymphocyte count) : cells/mm3 | through study completion, an average of 1 year |
| Changes in blood test indicators : total cholesterol | Blood chemistry : total cholesterol (mg/dl) | through study completion, an average of 1 year |
| Changes in blood test indicators : total protein | Blood chemistry : total protein (g/dl) | through study completion, an average of 1 year |
| Changes in blood test indicators : albumin | Blood chemistry : albumin (g/dl) | through study completion, an average of 1 year |
| Changes in blood test indicators : AST | Blood chemistry : AST (aspartate aminotransferase) : IU/L | through study completion, an average of 1 year |
| Changes in blood test indicators : ALT | Blood chemistry : ALT (alanine aminotransferase) : IU/L | through study completion, an average of 1 year |
| Changes in blood test indicators : CRP | Blood chemistry : CRP (C-reactive protein) : mg/dl | through study completion, an average of 1 year |
| Changes in serum cytokines | ng/ml | 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 | 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 | 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). | 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). | 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) | through study completion, an average of 1 year |
| Infection rate | proportion | During the hospitalization (approximately up to 2 weeks) |
| Total days of hospitalization | day | at Discharge Day (POD#8; postoperative day 8) |
| Mortality rate | proportion | through study completion, an average of 1 year |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |