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Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
Subject 1: subtotal gastrectomy group
subject 2: total gastrectomy group
Objectives:
Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy
Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo
Secondary objectives:
weight loss(%) of each subgroup, nutritional parameters (PG-SGA), Calrorie intake & dietary habits, albumin, hemoglobin, iron panel (TIBC, ferritin), Absolute lymphocyte count(ALC), vit B12, homocysteine, quality of life(QOL) change
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SE-STG | Active Comparator | simplified dietary education arm in subtotal gastrectomy group. |
|
| IE-STG | Active Comparator | intensive dietary education arm in subtotal gastrectomy group |
|
| SE-TG | Active Comparator | simplified dietary education arm in total gastrectomy group. |
|
| IE-TG | Active Comparator | intensive dietary education arm in total gastrectomy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary education(nutritional counselling) | Other | Dietary education provided to gastrectomy patients by dietitian. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from preoperative weight change at immediate postoperative period in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, immediate postoperative |
| Change from preoperative weight change at postoperaive 1 month in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, postoperative 1 month |
| Change from preoperative weight change at postoperaive 3 months in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, postoperative 3 months |
| Change from preoperative weight change at postoperaive 6 months in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, postoperative 6 months |
| Change from preoperative weight change at postoperaive 12 months in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, postoperative 12 months |
| Change from preoperative weight change at postoperaive 18 months in SE and IE groups. | comparison of weight change between the two groups after surgery | preoperative, postoperative 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional parameters | measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C) | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| 24hrs dietary recall |
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Inclusion Criteria:
histologically proven primary gastric adenocarcinoma,
T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
No evidence of other distant metastasis,
age ≥ 20 year old, ≤ 75 year old
no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
adequate organ functions defined as indicated below:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae-Moon Bae, MD, Ph.D | Contact | 82-2-3410-0252 | jmoon.bae@samsung.com | |
| Aron Lee, RD | Contact | 82-2-3410-0498 |
| Name | Affiliation | Role |
|---|---|---|
| Aron Lee, RD | Samsung Medical Center | Study Director |
| Bo Ram Park, Ph.D. | Samsung Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41093778 | Derived | Lee AR, Bae JM, Choi MG, An JY, Kim EM, Park B. Nutritional Counseling for Patients With Gastric Cancer After Subtotal Gastrectomy: A Randomized Clinical Trial. J Gastric Cancer. 2025 Oct;25(4):593-604. doi: 10.5230/jgc.2025.25.e43. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2023 | Oct 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Simplified dietary education(SE) versus Intensive dietary education(IE)
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double blind
calculating kcal & protein intake by 24hrs dietary recall (questionnaire)
| preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| dietary habits | number of meals, eating speed (questionnaire) | preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months |
| Albumin | g/dL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Hemoglobin | g/dL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Total iron binding capacity (TIBC) | μg/dL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Ferritin | ng/mL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Absolute lymphocyte count (ALC) | 10^3/μL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Vitamin B12 | pg/mL | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Homocysteine | μmol/L | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| Quality of life of the patients | European quality of life questionnaire (EQ-5D); the descriptive system which comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |