Effects of Omega-3 Fish Oil Fat Emulsion on Rehabilitation and Immune Function After Radical Surgery Combined With Intraperitoneal Hyperthermic Infusion Chemotherapy in Patients With Locally Advanced Gastric Cancer
NCT ID: NCT06047158
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-12-01
2023-12-01
Brief Summary
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The main question it aims to answer is whether the use of omega-3 fish oil fat emulsion can improve patients' immunity, speed up recovery and reduce costs.
Participants will comprehensively collect patient-related baseline data, including sex, age, BMI, ASA grade, tumor location, histological grade, pathological tumor type, pTNM stage (AJCC cancer stage 8), and perilymphatic vascular / nerve infiltration.
Immune function evaluation related index: peripheral blood lymphocyte count. Plasma albumin concentration, C-reactive protein, postoperative infectious complications, length of stay and cost of hospitalization.
Finally, statistical analysis software was used to analyze the differences between the two groups, evaluate the above indicators and draw mutual conclusions.
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Detailed Description
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1. Select patients in the group according to the inclusion and exclusion criteria.
2. The patient signed the informed consent form
3. His system was used to collect patient data, including human-related baseline data, including sex, age, BMI, ASA grade, tumor location, histological grade, pathological tumor type, pTNM stage (AJCC cancer stage 8th edition), lymphatic vascular / nerve infiltration. Immune function evaluation related index: peripheral blood lymphocyte count. Plasma albumin concentration, C-reactive protein, postoperative infectious complications, length of stay and cost of hospitalization.
4. Using statistical software (SPSS) to judge the statistical difference.
5. It is concluded that the use value of omega-3 fish oil fat emulsion (Ewing) is evaluated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fish oil group
The patients in this group were treated with omega-3 fish oil fat emulsion at a dose of 100ml/ per person per day for 5 days and added to a three-liter bag (containing water, glucose, amino acids, sodium chloride, vitamins, etc.) except fish oil.
Drug introduction:
Full name: omega-3 fish oil fat emulsion. Common name: Juventus. Specification: 100ml / 10g
Omega-3 fish oil fat emulsion
Use omega-3 fish oil fat emulsion
Non-fish oil group
Do not use omega-3 fish oil fat emulsion (no omega-3 fish oil fat emulsion is added to the three-liter bag, other substances are the same)
No interventions assigned to this group
Interventions
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Omega-3 fish oil fat emulsion
Use omega-3 fish oil fat emulsion
Eligibility Criteria
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Inclusion Criteria
* For advanced gastric cancer, according to the TNM staging specified by the 8th edition AJCC, the clinical staging or EUS staging is above T2. There is no distant metastasis before operation, and the tumor does not directly invade the surrounding organs (liver, pancreas, spleen and transverse mesocolon, etc.).
* There is no obvious contraindication to surgery.
* The preoperative physical status score of Eastern American Cancer Cooperation (ECOG) was 0 or 1.
* The preoperative ASA grade was grade Ⅰ-Ⅲ.
* No previous history of gastric surgery, no history of other malignant tumors.
* After explaining the nature and purpose of the study, agree to sign an informed consent form, give voluntary consent to participate in the study, and comply with the requirements of the study.
Exclusion Criteria
* Use of immunosuppressants such as hormones within 3 months before treatment.
* Preoperative anemia (hemoglobin \< 90g/L) and severe hypoalbuminemia (albumin \< 30g/L).
* With severe heart and lung and other important organ dysfunction.
* More serious metabolic and immune diseases, such as hyperthyroidism, poor blood glucose control in diabetes, obesity, hyperlipidemia (triglyceride \> 3mmol/L, total bile solid \> 6.2mmol/L).
* Severe infection before operation.
* With complete intestinal obstruction, intestinal perforation and intestinal necrosis.
* During the operation, it was found that radical operation could not be performed or combined organ resection was needed.
* Operation time \> 6 hours, intraoperative bleeding \> 400ml
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Locations
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Ruiqing Liu
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCEOFOITP
Identifier Type: -
Identifier Source: org_study_id
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