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

Primary Purpose

Oncology, Metabolic Disease, Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oncometabolic reconstruction
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncology focused on measuring Oncometabolic surgery, Long limb uncut Roux-en-Y gastrojejunostomy, Obesity, Diabetes, Early gastric cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Oncometabolic reconstruction

    Arm Description

    Patients undergoing oncometablic surgery

    Outcomes

    Primary Outcome Measures

    micronutrients' deficiency (iron, folate, vitamin B12)
    Iron deficiency : serum ferritin < 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 < 200 pg/mL,

    Secondary Outcome Measures

    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
    Body mass index (BMI) change
    Preoperative BMI minus postoperative BMI
    Remission rates of co-morbidities

    Full Information

    First Posted
    February 23, 2017
    Last Updated
    April 10, 2019
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03067012
    Brief Title
    Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients
    Acronym
    ONCOMETAB
    Official Title
    Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery (Long Limb Uncut Roux-en Y Gastrojejunostomy) for Obese Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    July 5, 2016 (Actual)
    Study Completion Date
    July 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oncology, Metabolic Disease, Gastric Cancer
    Keywords
    Oncometabolic surgery, Long limb uncut Roux-en-Y gastrojejunostomy, Obesity, Diabetes, Early gastric cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oncometabolic reconstruction
    Arm Type
    Experimental
    Arm Description
    Patients undergoing oncometablic surgery
    Intervention Type
    Other
    Intervention Name(s)
    Oncometabolic reconstruction
    Intervention Description
    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 Outcome Measure Information:
    Title
    micronutrients' deficiency (iron, folate, vitamin B12)
    Description
    Iron deficiency : serum ferritin < 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 < 200 pg/mL,
    Time Frame
    postoperative 1-year
    Secondary Outcome Measure Information:
    Title
    anemia incidence
    Description
    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
    Time Frame
    postoperative 1-year
    Title
    Body mass index (BMI) change
    Description
    Preoperative BMI minus postoperative BMI
    Time Frame
    postoperative 1-year
    Title
    Remission rates of co-morbidities
    Time Frame
    postoperative 1-year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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