Gastric Cancer, Metabolic Disease, Oncology
Conditions
Keywords
Oncometabolic surgery, Long limb uncut Roux-en-Y gastrojejunostomy, Obesity, Diabetes, Early gastric cancer
Brief summary
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
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.
Interventions
OTHEROncometabolic reconstruction
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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| micronutrients' deficiency (iron, folate, vitamin B12) | postoperative 1-year | Iron deficiency : serum ferritin \< 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 \< 200 pg/mL, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anemia incidence | postoperative 1-year | 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 |
| Body mass index (BMI) change | postoperative 1-year | Preoperative BMI minus postoperative BMI |
| Remission rates of co-morbidities | postoperative 1-year | — |
Outcome results
None listed