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The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Primary Objective:
The primary end points:
To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
Secondary Objectives:
(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.
(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.
Plan of the Study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunomodulating nutrients enriched diet | Experimental | Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. |
|
| standard diet | Active Comparator | Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunomodulating nutrients enriched diet | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| immunomodulating effects | Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes. | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| blood glucose | at discharge from the hospital or 14 days after surgery, whichever occurred first | |
| blood urine nitrogen | at discharge from the hospital or 14 days after surgery, whichever occurred first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaw-Yuan Wang, PhD | Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ho Memorial Hospital, Kaohsiung Medical University: | Kaohsiung City | 807 | Taiwan |
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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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| standard diet |
| Dietary Supplement |
|
| blood aspartate aminotransferase (AST) in U/L | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood alanine aminotransferase (ALT) in U/L | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood triglycerides (TG) in mg/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood cholesterol in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood low-density lipoprotein (LDL) in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood high-density lipoprotein (HDL) in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood sodium (Na) mEq/L | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood leukocyte count cells/μL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood albumin in g/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| blood prealbumin in mg/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| body mass index (BMI) in kg/m^2 | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| postoperative complications | postoperative complications that related to surgery | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| time to first bowel action | interval of surgery to first bowel action (hours) | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| length of hospital stay after surgery | length of hospital stay after surgery (days) | at discharge from the hospital or 14 days after surgery, whichever occurred first |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |