Status:
RECRUITING
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Lead Sponsor:
Samsung Medical Center
Conditions:
Gastric Cancer
Gastrectomy
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 dieta...
Eligibility Criteria
Inclusion
- 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:
- WBC count: 3000/mm3 \~12,000/mm3,
- \> serum Hemoglobin 8.0 g/dL
- \> serum Platelet 100 000/mm3,
- \< serum AST 100 IU/L,
- \<serum ALT 100 IU/L,
- \< Total Bilirubin 2.0 mg/dL,
- written signed informed consent
Exclusion
- active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
- gastric remnant cancer
- ≥T3, T4 in surgical staging before resection
- N2 or more (number of metastatic lymph nodes ≥3) in CT scan
- histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
- pregnant or breast-feeding women,
- mental disorder(diagnosed with mental disorder on medical record),
- unstable angina or myocardial infarction within 6 months of the trial,
- unstable hypertension,
- diabetes mellitus on insulin,
- severe respiratory disease requiring continuous oxygen therapy,
- previous upper abdominal surgery except laparoscopic cholecystectomy,
- surgical complication
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT04798820
Start Date
March 9 2021
End Date
October 1 2025
Last Update
July 15 2024
Active Locations (1)
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1
Samsung medical center
Seoul, South Korea, 06351