Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients

Study Overview
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Brief Summary
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The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early gastric cancer patients has been revealed in a few pilot studies. However, the nutritional safety has not been dealt with in previous literatures. This is a prospective pilot study for evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese early gastric cancer patients.

Detailed Description
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We performed long limb uncut Roux-en Y gastrojejunostomy (uRYGJ) in 20 patients with clinical T1N0 stage and preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities between September 2015 and July 2016. The primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin B12) at postoperative 1 year and secondary endpoints were anemia incidence, BMI change and remission rates of co-morbidities.

Official Title
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Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery (Long Limb Uncut Roux-en Y Gastrojejunostomy) for Obese Gastric Cancer

Conditions
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Oncology, Metabolic Disease, Gastric Cancer

Intervention / Treatment
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* Other: Oncometabolic reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lesion located on distal or mid stomach Lesion confined to submucosa (cT1b) : Early gastric cancer No evidence of metastatic enlarged lymph nodes Preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities Exclusion Criteria: Being unable to understand the risks, benefits and compliance requirements of this trial Non- Korean speaker American society of anesthesiology (ASA) class IV or higher Other malignancy within 5 years.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncometabolic reconstruction<br>Patients undergoing oncometablic surgery | Other: Oncometabolic reconstruction<br>* The length of biliopancreatic limb is 50cm and the length of Roux limb is 100cm. (long limb uncut Roux-en-Y gastrojejunostomy) These limbs are longer than the conventional uncut Roux-en-Y reconstruction for gastric cancer patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| micronutrients' deficiency (iron, folate, vitamin B12) | Iron deficiency : serum ferritin < 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 < 200 pg/mL, | postoperative 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anemia incidence | Iron deficiency anemia : anemia with concomitant iron deficiency, Anemia of chronic illness : anemia with serum ferritin > 20 μg/dL, Anemia from vitamin B12 deficiency : megaloblastic anemia (MCV >100 fL) with vitamin B12 deficiency | postoperative 1-year | 
| Body mass index (BMI) change | Preoperative BMI minus postoperative BMI | postoperative 1-year | 
| Remission rates of co-morbidities |  | postoperative 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncometabolic surgery, Long limb uncut Roux-en-Y gastrojejunostomy, Obesity, Diabetes, Early gastric cancer