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Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

Primary Purpose

Gastric Cancer, Benign Gastric Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic gastrectomy
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring Body composition measurement, Lipid profile, Weight loss, Gastrectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Patient with gastric cancer or benign gastric neoplasm planning gastric operation
  • Stage I and II patients by preoperative screening

Exclusion Criteria:

  • Distant metastasis
  • Severe comorbidity
  • Malnourished state
  • Inability of access to enteral feeding

Sites / Locations

  • Hanyang University Seoul Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Non-Obese

Obese

Arm Description

Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2

Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2

Outcomes

Primary Outcome Measures

Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed

Secondary Outcome Measures

Changes in lipid profile
Using laboratory analysis, changes in the lipid profiles (total cholesterol (TC), triglyceride (TG), LDL-C and HDL-C) following gastric operation assessed

Full Information

First Posted
September 1, 2015
Last Updated
August 10, 2018
Sponsor
Hanyang University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02541461
Brief Title
Body Composition After Laparoscopic Gastrectomy for Gastric Cancer
Official Title
Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Nutritional status including changes of body composition is one of the most important clinical determinants of outcome after gastrectomy for gastric cancer. Various type of gastric operations are widely used with favorable outcome in South Korea. It was reported that several advantages of laparoscopic gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6 months after surgery. But there have been no longitudinal studies evaluating changes in the body composition according to the different type of anastomosis of laparoscopic gastrectomy. The purpose of this prospective study was to investigate changes in lipid indices associated with whole body composition during 1 year of follow-up after laparoscopic gastrectomy. Gastrectomy resulted in improved lipid indices and a reduction in body weight, fat and LBM. The HDL-Csignificantly increased in the non-obese group for 1 year after gastrectomy and the reduction of TG level was positively correlated with fat, especially with trunk fat.
Detailed Description
All patients will undergo a laparoscopic gastrectomy for their gastric cancer (proved to be stage I or II) or benign gastric neoplasm by preoperative screening diagnostic procedure. They will receive laparoscopic gastrectomy as follows: (1) wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) laparoscopic gastrectomy; (4 gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy. Pre-operative, 6 and 12 months post-operative body composition measurement will be performed on each patient. The whole body composition measurement will be assessed by Hologic 4500/A dual energy X-ray absorptiometry system. The software performs calculations of the differential attenuations of the two photon energies and present data of percentage of fat, fat mass (g), lean mass (g), bone mineral content (g), bone mineral density (g/cm2), and total mass (g). Laboratory analysis - There is a battery of labs that are ordered in both the pre-operative, 6 and 12 months post-operative time frame. These labs are ordered independent of the patient's participation in the study. These labs are ordered to evaluate and to assist management of the patient's medical comorbidities as well as to assess for adequate nutritional intake and balance. Queries on nutritional intake and exercise will be made at each post-operative appointment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Benign Gastric Tumor
Keywords
Body composition measurement, Lipid profile, Weight loss, Gastrectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Obese
Arm Type
Other
Arm Description
Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2
Arm Title
Obese
Arm Type
Other
Arm Description
Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Intervention Description
(1) Wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) Laparoscopic gastrectomy; (4) Gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy
Primary Outcome Measure Information:
Title
Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
Description
Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed
Time Frame
pre-surgery, 6 and 12 months post-surgery
Secondary Outcome Measure Information:
Title
Changes in lipid profile
Description
Using laboratory analysis, changes in the lipid profiles (total cholesterol (TC), triglyceride (TG), LDL-C and HDL-C) following gastric operation assessed
Time Frame
pre-surgery, 6 and 12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with gastric cancer or benign gastric neoplasm planning gastric operation Stage I and II patients by preoperative screening Exclusion Criteria: Distant metastasis Severe comorbidity Malnourished state Inability of access to enteral feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Young Choi, MD, PhD
Organizational Affiliation
Hanyang University Seoul Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20151217
Citation
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Results Reference
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PubMed Identifier
8180768
Citation
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PubMed Identifier
19343439
Citation
Lee HJ, Kim HH, Kim MC, Ryu SY, Kim W, Song KY, Cho GS, Han SU, Hyung WJ, Ryu SW; Korean Laparoscopic Gastrointestinal Surgery Study Group. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9. doi: 10.1007/s00464-009-0419-1. Epub 2009 Apr 3.
Results Reference
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PubMed Identifier
18663532
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
11768259
Citation
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Results Reference
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

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