Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Study Overview
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Brief Summary
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Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.

Detailed Description
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The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.

Official Title
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The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)

Conditions
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Metabolic Syndrome, Gastric Cancer

Intervention / Treatment
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* Procedure: Omentum preserving
* Procedure: Total omentectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma in stomach Aged≥20 years and ≤80 years Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0) Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria ECOG 0 (Eastern Cooperative Oncology Group) ASA score class I-III (American Society of Anesthesiologists) patient has given their written informed consent to participate in the study Exclusion Criteria: Simultaneously combined resection of other organ Active other malignancy Expected to severe intra-abdominal adhesion due to previous abdominal operation history Uncontrolled co-morbidity Vulnerable patients

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Omentum preserving<br>Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed. | Procedure: Omentum preserving<br>* The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.<br>|
| Experimental: Total omentectomy<br>Total omentectomy: Whole omentum will be removed. | Procedure: Total omentectomy<br>* Whole omentum will be removed during gastrectomy with lymph node dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR change | HOMA-IR change after operation | pre-operative and post-operative 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of metabolic syndrome | check the presence of metabolic syndrome | pre-operative and post-operative 12months | 
| Complication | short-term any complication related to surgery | within 30days | 
| HOMA-IR change according to anastomosis type | comparison between Billoth-II and Roux-en-Y | pre-operative and post-operative 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, gastric cancer, omentectomy