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Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02541461
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Young Kim, Hanyang University Seoul Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Benign Gastric Tumor Procedure: Laparoscopic gastrectomy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Non-Obese
Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2
 Procedure: Laparoscopic gastrectomy
(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
Obese
Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2
 Procedure: Laparoscopic gastrectomy
(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


Outcome Measures
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Primary Outcome Measures :
  1. Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic) [ Time Frame: pre-surgery, 6 and 12 months post-surgery ]
    Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed


Secondary Outcome Measures :
  1. Changes in lipid profile [ Time Frame: pre-surgery, 6 and 12 months post-surgery ]
    Using laboratory analysis, changes in the lipid profiles (total cholesterol (TC), triglyceride (TG), LDL-C and HDL-C) following gastric operation assessed


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541461


Locations
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Korea, Republic of
Hanyang University Seoul Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanyang University Seoul Hospital
Investigators
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Principal Investigator: Yun Young Choi, MD, PhD Hanyang University Seoul Hospital
More Information
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Publications:

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Responsible Party: Ji Young Kim, Clinical Professor, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT02541461    
Other Study ID Numbers: 2015-04-026-002
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Keywords provided by Ji Young Kim, Hanyang University Seoul Hospital:
Body composition measurement
Lipid profile
Weight loss
Gastrectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases