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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Liu Ruiqing, Doctor; Phone Number: 18661809036; Email: liuruiqing@smail.nju.edu.cn

Study Locations

• China
  • Shan Dong
    • Qingdao, Shan Dong, China, 266003
      • Recruiting
      • Ruiqing Liu
      • Contact: Wang Dongsheng, Doctor; Phone Number: 18661807896; Email: wangds0538@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population were patients with advanced gastric cancer who had received surgical treatment. According to the wishes of the patients, they chose whether to use omega-3 fish oil fat emulsion and were assigned to different groups to observe the effect.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune related index	Peripheral blood lymphocyte count	one week
Immune related index	Plasma albumin concentration	one week
Immune related index	C-reactive protein concentration	one week
Immune related index	Postoperative infectious complications	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization related	Hospitalization time	From the first day after operation to discharge, up to 30 days.
Hospitalization related	Hospitalization expenses	From the first day after operation to discharge, up to 30 days.

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: RCEOFOITP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No