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

Recruiting

• Conditions: Fish Oils; Perfusion; Complications; Stomach Neoplasms; Nutrition Aspect of Cancer; Chemotherapy Effect; Immunisation Reaction
• Interventions: Drug: Omega-3 fish oil fat emulsion

• Registration Number: NCT06047158
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The purpose of this study was to investigate the effects of omega-3 fish oil fat emulsion on peripheral blood C-reactive protein, total lymphocyte count, plasma albumin and immune function after radical surgery combined with intraperitoneal hyperthermic perfusion chemotherapy in patients with locally advanced gastric cancer. at the same time, to explore the effects of omega-3 fish oil fat emulsion on complications, length of stay and total cost of hospitalization.

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.

Detailed Description

The research process is as follows:

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.

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• The age is 18 to 75 years old.
• 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

• Radiotherapy or chemotherapy before operation.
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fish oil group	Omega-3 fish oil fat emulsion	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

Primary Outcome Measures

Name	Time	Method
Immune related index	one week	Postoperative infectious complications

Secondary Outcome Measures

Name	Time	Method
Hospitalization related	From the first day after operation to discharge, up to 30 days.	Hospitalization expenses

Trial Locations

Locations (1)

Ruiqing Liu; 🇨🇳 Qingdao, Shan Dong, China