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

Not Applicable

Completed

• Conditions: Oncology; Gastric Cancer; Metabolic Disease
• Interventions: Other: Oncometabolic reconstruction

• Registration Number: NCT03067012
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-07-05
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-03-01
• Study Completion: 2017-07-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncometabolic reconstruction	Oncometabolic reconstruction	Patients undergoing oncometablic surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body mass index (BMI) change	postoperative 1-year	Preoperative BMI minus postoperative BMI
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
Remission rates of co-morbidities	postoperative 1-year