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

Gastric Cancer Clinical Trial

— ONCOMETAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067012
• Other study ID #: SNUBH010
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: April 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2017
• Est. primary completion date: July 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Metabolic Disease
• Metabolic Diseases
• Oncology
• Stomach Neoplasms

Intervention

Other:
• Oncometabolic 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Body mass index (BMI) change	Preoperative BMI minus postoperative BMI	postoperative 1-year
Secondary	Remission rates of co-morbidities		postoperative 1-year