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NCT Number: NCT03067012

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

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.

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Key information

Conditions

Oncology Body Weight Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncometabolic reconstruction

Other

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.

Primary outcomes

  1. micronutrients' deficiency (iron, folate, vitamin B12)

    Time frame: postoperative 1-year

    Iron deficiency : serum ferritin < 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 < 200 pg/mL,

Secondary outcomes

  1. anemia incidence

    Time frame: 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

  2. Body mass index (BMI) change

    Time frame: postoperative 1-year

    Preoperative BMI minus postoperative BMI

  3. Remission rates of co-morbidities

    Time frame: postoperative 1-year

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: ONCOMETAB

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 1, 2017
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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