Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the role of the type of omentectomy (partial or total) in the treatment of Tis - T3 gastric cancer without serosal infiltration. The second purpose is to monitoring the blood levels of immunological factors (interleukins, T cell subtypes, etc.) pre-and postoperatively, depending on the type of omentectomy.

Detailed Description
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Gastric cancer is the second common tumor type. In 2020, the incidence of gastric cancer was over one million and caused about 770 000 tumor-associated deaths worldwide. Although the improvement of the perioperative oncological therapy is unquestionable, the major point of the treatment is radical surgical intervention. Laparoscopic technic is widespread in the treatment of gastric cancer, too. For the oncological radicality total or subtotal gastrectomy with D2 omentectomy is necessary, but the opinions are divided about the role of the omentectomy. Total omentectomy in laparoscopic operations takes more time and increases the postoperative morbidity, blood loss, and opportunity of the anastomosis insufficiency, and the incidence of the omental metastases is just between 3,8 - 5%. Based on this, many international guidelines allow partial omentectomy in early gastric cancer. At the same time, in advanced gastric neoplasm, the place of the partial omentectomy is still unclear. With this prospective, randomized, multicentric study we plan to compare the total and partial omentectomy in the surgery of Tis - T3 gastric cancer with the analysis of the postoperative morbidity and mortality and long-term survival factors.

Official Title
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A Multicenter, Prospective, Randomized Trial to Evaluate the Role of Total Versus Partial Omentectomy in the Treatment of Tis - T3 Gastric Cancer.

Conditions
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Stomach Neoplasms, Interleukin, Stomach Cancer, Gastric Cancer, Digestive System Neoplasm

Intervention / Treatment
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* Procedure: Partial omentectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) I-III., Karnofsky Performance Score (KPS) >60, Eastern Cooperative Oncology Group (ECOG) 0-1 Tis-T3 gastric cancer without serosal infiltration and treated with the radical operation (R0; D2 lymphadenectomy, lymph nodes >16) clinical stadium: Tis-3; M0 written informed consent provided good patient compliance no previous chemotherapy or irradiation Exclusion Criteria: serosal infiltration and/or distant metastasis, omental infiltration, peritoneal carcinosis, positive abdominal cytological lavage organ transplantation and/or immunological disease and/or immunomodulation therapy another primary tumor decompensated chronic disease (for example: liver cirrhosis with ascites, kidney failure treated with hemodialysis, New York Heart Association (NYHA) IV. cardiac status, etc.) unsuccessful follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Total omentectomy<br>Total or subtotal gastrectomy with D2 lymphadenectomy and total omentectomy. | |
| Experimental: Partial omentectomy<br>Total or subtotal gastrectomy with D2 lymphadenectomy and partial omentectomy. | Procedure: Partial omentectomy<br>* Partial omentectomy: with preservation of the greater omentum at >2 cm from the gastroepiploic arcade.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3y Overall Surveillance | Duration from the operation to the date of death. | 3 years | 
| 3y Disease Free Surveillance | Duration from the operation to the date of radiological or histological proven relapse. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications (Clavien - Dindo classification) and morbidity | Incidence of 30 days postoperative morbidity (Clavien - Dindo classification). | 30 days | 
| Postoperative immunological changes (Interleukin monitoring) | Compare the pre-and postoperative interleukin blood levels to monitoring the immunological answer after total or partial omentectomy. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, total omentectomy, partial omentectomy, stomach cancer, interleukin, immunological answer