Clinical trial NCT02541461: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Benign Gastric Tumor
Keywords: Body composition measurement
Lipid profile
Weight loss
Gastrectomy
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
timeFrame: pre-surgery, 6 and 12 months post-surgery
Secondary outcomes:
measure: Changes in lipid profile
timeFrame: pre-surgery, 6 and 12 months post-surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Yun Young Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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